Trial Outcomes & Findings for Control of Major Bleeding After Trauma Study (NCT NCT01838863)

Results Overview

death within 28 days post injury (death of any cause except for death due to a second, clearly unrelated traumatic injury suffered after discharge)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

144 participants

Primary outcome timeframe

28 days

Results posted on

2019-01-08

Participant Flow

The enrollment and randomization occurred almost simultaneously. Once the paramedics determined the patient to be eligible, the cooler was opened and the randomization was done based on the cooler content: cooler with plasma randomized the patient to the experimental and cooler with frozen water randomized the patient to the control group.

Participant milestones

Participant milestones
Measure	Plasma If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Overall Study STARTED	75	69
Overall Study COMPLETED	65	60
Overall Study NOT COMPLETED	10	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The body temperature was measured in the field with a temporal scanner infrared thermometer. Due to the specifics of the study (acute trauma setting), it was not always possible to obtain a body temperature reading in the field (accident scene).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Plasma n=65 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=60 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid	Total n=125 Participants Total of all reporting groups
Age, Continuous	33 years n=65 Participants	32.5 years n=60 Participants	33 years n=125 Participants
Sex: Female, Male Female	13 Participants n=65 Participants	9 Participants n=60 Participants	22 Participants n=125 Participants
Sex: Female, Male Male	52 Participants n=65 Participants	51 Participants n=60 Participants	103 Participants n=125 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=65 Participants	39 Participants n=60 Participants	73 Participants n=125 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=65 Participants	21 Participants n=60 Participants	52 Participants n=125 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=65 Participants	0 Participants n=60 Participants	0 Participants n=125 Participants
Region of Enrollment United States	65 participants n=65 Participants	60 participants n=60 Participants	125 participants n=125 Participants
Body Mass Index (BMI)	27.1 kg/m^2 n=65 Participants	26.1 kg/m^2 n=60 Participants	26.7 kg/m^2 n=125 Participants
Comorbidities	10 Participants n=65 Participants	8 Participants n=60 Participants	18 Participants n=125 Participants
Blunt injury mechanism	30 Participants n=65 Participants	32 Participants n=60 Participants	62 Participants n=125 Participants
New Injury Severity Scale (NISS)	27 units on a scale n=65 Participants	27 units on a scale n=60 Participants	27 units on a scale n=125 Participants
Maximal Abbreviated Injury Score (AIS) for head and neck	0 units on a scale n=65 Participants	0 units on a scale n=60 Participants	0 units on a scale n=125 Participants
Traumatic Brain Injury (TBI) defined as AIS head >=3	15 Participants n=65 Participants	13 Participants n=60 Participants	28 Participants n=125 Participants
Maximal Abbreviated Injury Score (AIS) chest	1 units on a scale n=65 Participants	3 units on a scale n=60 Participants	2 units on a scale n=125 Participants
Maximal Abbreviated Injury Score (AIS) abdomen and pelvis	0 units on a scale n=65 Participants	0 units on a scale n=60 Participants	0 units on a scale n=125 Participants
Maximal Abbreviated Injury Score (AIS) extremities	1 units on a scale n=65 Participants	0 units on a scale n=60 Participants	0 units on a scale n=125 Participants
Heart rate (HR) in the field	110 beats per minute (BPM) n=65 Participants	112 beats per minute (BPM) n=60 Participants	110 beats per minute (BPM) n=125 Participants
Systolic blood pressure (SBP) in the field	64 mmHg n=65 Participants	70 mmHg n=60 Participants	68 mmHg n=125 Participants
Severe shock defined as systolic blood pressure (SBP) in the field <=70mmHg	44 Participants n=65 Participants	33 Participants n=60 Participants	77 Participants n=125 Participants
Body temperature in the field	36 degrees Celsius n=38 Participants • The body temperature was measured in the field with a temporal scanner infrared thermometer. Due to the specifics of the study (acute trauma setting), it was not always possible to obtain a body temperature reading in the field (accident scene).	36 degrees Celsius n=29 Participants • The body temperature was measured in the field with a temporal scanner infrared thermometer. Due to the specifics of the study (acute trauma setting), it was not always possible to obtain a body temperature reading in the field (accident scene).	36 degrees Celsius n=67 Participants • The body temperature was measured in the field with a temporal scanner infrared thermometer. Due to the specifics of the study (acute trauma setting), it was not always possible to obtain a body temperature reading in the field (accident scene).
Glasgow Coma Scale (GCS) in the field	14 units on a scale n=65 Participants	14 units on a scale n=60 Participants	14 units on a scale n=125 Participants
Haemoglobin (Hb) in the field	15.1 g/dL n=32 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).	14.2 g/dL n=27 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).	14.6 g/dL n=59 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).
Platelet count in the field	300.5 1000 cells/microL n=26 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).	273.5 1000 cells/microL n=20 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).	287.5 1000 cells/microL n=46 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).
Fibrinogen in the field	253 mg/dL n=35 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).	278 mg/dL n=29 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).	268 mg/dL n=64 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).
International normalized ratio (INR) in the field	1.1 ratio n=36 Participants • Measure Analysis Population Description: Defined as the first international normalized ratio (INR) obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83-1.19.	1.1 ratio n=29 Participants • Measure Analysis Population Description: Defined as the first international normalized ratio (INR) obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83-1.19.	1.1 ratio n=65 Participants • Measure Analysis Population Description: Defined as the first international normalized ratio (INR) obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83-1.19.
International normalized ratio (INR) in the field >=1.3	2 Participants n=36 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).	2 Participants n=29 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).	4 Participants n=65 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).
Partial thromboplastin time (PTT) in the field	27.1 seconds n=36 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).	26.9 seconds n=28 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).	27.1 seconds n=64 Participants • Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).

PRIMARY outcome

Timeframe: 28 days

death within 28 days post injury (death of any cause except for death due to a second, clearly unrelated traumatic injury suffered after discharge)

Outcome measures

Outcome measures
Measure	Plasma n=65 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=60 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Number of Participants That Died Within 28 Days Post Injury	10 Participants	6 Participants

SECONDARY outcome

Timeframe: 28 days

The occurrence of in-hospital death or MOF within the first 28 days postinjury. MOF is defined using the validated Denver MOF score (Denver MOF score\>3 of simultaneously obtained scores after 48 hours postinjury).

Outcome measures

Outcome measures
Measure	Plasma n=65 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=60 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Composite Outcome of 28-day In-hospital Mortality and Postinjury Multiple Organ Failure (MOF) Incidence	14 Participants	7 Participants

SECONDARY outcome

Timeframe: within 30 minutes of Emergency Department (ED) arrival

Defined as the first international normalized ratio (INR) obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83-1.19. Usually, a high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.

Outcome measures

Outcome measures
Measure	Plasma n=63 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=58 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Admission Coagulopathy	1.27 ratio Interval 1.11 to 1.4	1.15 ratio Interval 1.08 to 1.29

SECONDARY outcome

Timeframe: within 30 minutes of Emergency Department (ED) arrival

Defined as international normalized ratio (INR) \>1.3 obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83-1.19. Usually, a high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.

Outcome measures

Outcome measures
Measure	Plasma n=63 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=58 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Number of Participants With Admission Severe Coagulopathy	28 Participants	14 Participants

SECONDARY outcome

Timeframe: within 30 minutes of ED arrival

Admission clot strength will be measured by thrombelastography G-value upon ED arrival. Clot strength measured in kilodynes per square centimetre (kdyn/cm\^2).

Outcome measures

Outcome measures
Measure	Plasma n=55 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=51 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Admission Clot Strength	7.7 kdyne/cm^2 Interval 6.2 to 8.9	7.1 kdyne/cm^2 Interval 5.4 to 9.7

SECONDARY outcome

Timeframe: within 30 minutes of ED arrival

Admission acidosis measured by lactate upon ED arrival.

Outcome measures

Outcome measures
Measure	Plasma n=53 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=52 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Admission Acidosis	5.5 mmol/L Interval 3.9 to 8.5	4.9 mmol/L Interval 3.2 to 7.0

SECONDARY outcome

Timeframe: within 30 minutes of ED arrival

Admission severe acidosis measured by lactate\>5 upon ED arrival.

Outcome measures

Outcome measures
Measure	Plasma n=53 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=52 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Number of Participants With Admission Severe Acidosis	27 Participants	25 Participants

SECONDARY outcome

Timeframe: within 30 minutes of ED arrival

Admission acidosis will be defined by base deficit (BD) upon ED arrival.

Outcome measures

Outcome measures
Measure	Plasma n=51 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=50 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Admission Acidosis	9 mEq/L Interval 5.5 to 13.0	8.8 mEq/L Interval 6.0 to 13.0

SECONDARY outcome

Timeframe: within 30 minutes of ED arrival

Admission severe acidosis will be defined by base deficit (BD\>10) upon ED arrival.

Outcome measures

Outcome measures
Measure	Plasma n=51 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=50 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Number of Participants With Admission Severe Acidosis	21 Participants	22 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: after injury and prior to hospital arrival, at about 15 minutes after injury

defined as the first coagulation factor level obtained in the field prior to intervention Coagulation Factor Reference Ranges F2 F5 F7 F8 F9 F11 * % % % % % % 67.0 - 107.0 63.0 - 116.0 52.0 - 120.0 58.0 - 132.0 47.0 - 122.0 52.0 - 120.0

Outcome measures

Outcome measures
Measure	Plasma n=34 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=26 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Baseline (Field) Coagulation Factor Levels Coagulation factor II (prothrombin)	95 percentage of activity Interval 85.0 to 105.0	98 percentage of activity Interval 85.0 to 105.0
Baseline (Field) Coagulation Factor Levels Coagulation factor V (proaccelerin)	85 percentage of activity Interval 73.0 to 99.0	91.5 percentage of activity Interval 77.0 to 100.0
Baseline (Field) Coagulation Factor Levels Coagulation factor VII (proconvertin)	101.5 percentage of activity Interval 84.0 to 127.0	89.5 percentage of activity Interval 80.0 to 114.0
Baseline (Field) Coagulation Factor Levels Coagulation factor VIII (antihemophilic factor)	396.8 percentage of activity Interval 273.0 to 476.0	411.8 percentage of activity Interval 353.2 to 464.6
Baseline (Field) Coagulation Factor Levels Coagulation factor IX (plasma thromboplastin comp)	157 percentage of activity Interval 128.0 to 180.0	160.5 percentage of activity Interval 148.0 to 174.0
Baseline (Field) Coagulation Factor Levels Coagulation factor XI (plasma thromboplastin ante)	126.5 percentage of activity Interval 106.0 to 153.0	141.5 percentage of activity Interval 100.0 to 168.0

OTHER_PRE_SPECIFIED outcome

Timeframe: after injury prior to hospital arrival

defined as abnormal coagulation factor XIII level obtained in the field prior to intervention

Outcome measures

Outcome measures
Measure	Plasma n=34 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=26 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Number of Participants With Abnormal Baseline (Field) Coagulation Factor XIII Level	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: after injury prior to hospital arrival

Population: Not all the timepoints are available for all the patients.

defined as the first coagulation factor level obtained upon ED arrival Coagulation Factor Reference Ranges F2 F5 F7 F8 F9 F11 * % % % % % % 67.0 - 107.0 63.0 - 116.0 52.0 - 120.0 58.0 - 132.0 47.0 - 122.0 52.0 - 120.0

Outcome measures

Outcome measures
Measure	Plasma n=47 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=41 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Admission (First Arrival) Coagulation Factor Levels Coagulation factor VII (proconvertin)	72 percentage of activity Interval 56.0 to 94.0	74 percentage of activity Interval 52.0 to 94.0
Admission (First Arrival) Coagulation Factor Levels Coagulation factor I (fibrinogen)	195 percentage of activity Interval 157.0 to 275.0	222 percentage of activity Interval 154.5 to 282.0
Admission (First Arrival) Coagulation Factor Levels Coagulation factor II (prothrombin)	71 percentage of activity Interval 57.0 to 88.0	79 percentage of activity Interval 65.0 to 92.0
Admission (First Arrival) Coagulation Factor Levels Coagulation factor V (proaccelerin)	64 percentage of activity Interval 41.0 to 83.0	69 percentage of activity Interval 52.0 to 91.0
Admission (First Arrival) Coagulation Factor Levels Coagulation factor VIII (antihemophilic factor)	283.4 percentage of activity Interval 168.4 to 434.2	355.2 percentage of activity Interval 279.0 to 462.6
Admission (First Arrival) Coagulation Factor Levels Coagulation factor IX (plasma thromboplastin comp)	121 percentage of activity Interval 87.0 to 142.0	135 percentage of activity Interval 99.0 to 159.0
Admission (First Arrival) Coagulation Factor Levels Coagulation factor XI (plasma thromboplastin ante)	81 percentage of activity Interval 58.0 to 127.0	109 percentage of activity Interval 72.0 to 135.0

OTHER_PRE_SPECIFIED outcome

Timeframe: within 30 minutes of Emergency Department (ED) arrival

defined as the first abnormal factor XIII (fibrin-stabilizing factor) level obtained upon ED arrival

Outcome measures

Outcome measures
Measure	Plasma n=39 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=40 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Number of Participants With Abnormal Admission Coagulation Factor XIII (Fibrin-stabilizing Factor) Level	0 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Number of participants with 24-hour mortality, adverse outcome free days and transfusions

Outcome measures

Outcome measures
Measure	Plasma n=65 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=60 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Exploratory Analyses Required red blood cell transf. within 24 hour	36 Participants	35 Participants
Exploratory Analyses 24-hour mortality	8 Participants	6 Participants
Exploratory Analyses Acute lung injury (ALI) within 28 days	18 Participants	12 Participants
Exploratory Analyses Acute lung injury (ALI) within 6 hours post-transf	19 Participants	22 Participants
Exploratory Analyses MOF (Denver MOF score>3)	4 Participants	1 Participants
Exploratory Analyses Haemoglobin (Hb)<7g/dL within 6 hours	3 Participants	2 Participants
Exploratory Analyses Massive transf. (>=10 units of RBC or death/6 hrs	15 Participants	12 Participants
Exploratory Analyses Required plasma in first 24 h (not counting field)	29 Participants	26 Participants
Exploratory Analyses Required platelets in first 24 h	15 Participants	11 Participants
Exploratory Analyses Required cryoprecipitate in first 24 h	8 Participants	4 Participants
Exploratory Analyses Required tranexamic acid (TXA) in first 6 h	6 Participants	7 Participants
Exploratory Analyses Required factor VII infusion in first 24 h	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Adverse outcome free days

Outcome measures

Outcome measures
Measure	Plasma n=65 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=60 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Exploratory Analyses. Ventilator free days	26 days Interval 11.0 to 28.0	26 days Interval 18.0 to 28.0
Exploratory Analyses. Intensive care unit (ICU) free days	23 days Interval 7.0 to 26.0	24 days Interval 16.5 to 26.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Mortality, adverse outcome-free days and transfusions in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater

Outcome measures

Outcome measures
Measure	Plasma n=21 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=27 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock Acute lung injury (ALI) within 28 days	8 Participants	12 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock Acute lung injury (ALI) within 6 h post-transfusio	5 Participants	8 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock 28-day mortality	0 Participants	2 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock Death or multiple organ failure within 28 days	0 Participants	2 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock MOF (Denver MOF score>3)	0 Participants	0 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock Haemoglobin (Hb)<7g/dL within 6 hours	1 Participants	0 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock Required red blood cell transfusion within 24 h	7 Participants	14 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock Massive transf. (>=10 units of RBC or death/6 hrs	0 Participants	5 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock Required plasma in first 24 h (not counting field)	3 Participants	9 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock Required platelets in first 24 h	1 Participants	6 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock Required cryoprecipitate in first 24 h	0 Participants	2 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock Required tranexamic acid (TXA) in first 6 h	2 Participants	2 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock Required factor VII infusion in first 24 h	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Adverse outcome-free days in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater

Outcome measures

Outcome measures
Measure	Plasma n=21 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=27 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Adverse Outcome-free Days in a Sub-group With Less Severe Hemorrhagic Shock Ventilator free days	27 days Interval 22.0 to 28.0	26 days Interval 17.0 to 28.0
Adverse Outcome-free Days in a Sub-group With Less Severe Hemorrhagic Shock Intensive care unit (ICU) free days	24 days Interval 22.0 to 27.0	25 days Interval 12.0 to 26.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Level of Haemoglobin (Hb) in g/dL in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater

Outcome measures

Outcome measures
Measure	Plasma n=21 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=27 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Level of Haemoglobin (Hb) in a Sub-group With Less Severe Hemorrhagic Shock Admission (first arrival) Haemoglobin (Hb)	14.4 g/dL Interval 13.0 to 15.2	13.5 g/dL Interval 12.0 to 14.7
Level of Haemoglobin (Hb) in a Sub-group With Less Severe Hemorrhagic Shock Lowest Haemoglobin (Hb) in first 6 hours	11.6 g/dL Interval 10.1 to 13.6	11.4 g/dL Interval 9.3 to 13.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Transfusions of blood products in units in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater

Outcome measures

Outcome measures
Measure	Plasma n=21 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=27 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock Red blood cell (RBC) transfusion in 24 h	0 units Interval 0.0 to 2.0	1 units Interval 0.0 to 8.0
Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock Plasma transfused in 24h (excluding pre-admission)	0 units Interval 0.0 to 0.0	0 units Interval 0.0 to 2.0
Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock Platelets transfused in 24 h	0 units Interval 0.0 to 0.0	0 units Interval 0.0 to 0.0
Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock Cryoprecipitate transfused in 24 h	0 units Interval 0.0 to 0.0	0 units Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Time to Admission and First Blood Transfusion in minutes in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater

Outcome measures

Outcome measures
Measure	Plasma n=21 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=27 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Time to Admission and First Blood Transfusion in a Sub-group With Less Severe Hemorrhagic Shock Time from injury to ED admission	30 minutes Interval 25.0 to 40.0	25 minutes Interval 19.0 to 32.0
Time to Admission and First Blood Transfusion in a Sub-group With Less Severe Hemorrhagic Shock Time from injury to first unit of RBC	119.5 minutes Interval 44.5 to 159.5	39 minutes Interval 24.0 to 56.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Mortality, adverse outcome-free days and transfusions in the patients with initial systolic blood pressure (SBP) \<=70 mmHg

Outcome measures

Outcome measures
Measure	Plasma n=44 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=33 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock Death or multiple organ failure within 28 days	14 Participants	5 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock 24-hour mortality	8 Participants	4 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock Acute lung injury (ALI) within 28 days	20 Participants	18 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock Acute lung injury (ALI) within 6 h post-transfusio	14 Participants	14 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock MOF (Denver MOF score>3)	4 Participants	1 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock Haemoglobin (Hb)<7g/dL within 6 hours	2 Participants	2 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock Required red blood cell transfusion within 24 h	29 Participants	21 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock Massive transf. (>=10 units of RBC or death/6 hrs	15 Participants	7 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock Required cryoprecipitate in first 24 h	8 Participants	2 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock Required tranexamic acid (TXA) in first 6 h	4 Participants	5 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock Required factor VII infusion in first 24 h	1 Participants	0 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock 28-day mortality	10 Participants	4 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock Required plasma in first 24 h (not counting field)	26 Participants	17 Participants
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock Required platelets in first 24 h	12 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Population: Not all the timepoints are available for all the patients.

Adverse outcome-free days in the patients with initial systolic blood pressure (SBP) \<=70 mmHg

Outcome measures

Outcome measures
Measure	Plasma n=44 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=33 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Number of Adverse Outcome Free Days in a Sub-group With Severe Hemorrhagic Shock Ventilator free days	24.5 days Interval 0.0 to 27.5	26 days Interval 22.0 to 28.0
Number of Adverse Outcome Free Days in a Sub-group With Severe Hemorrhagic Shock Intensive care unit (ICU) free days	20 days Interval 0.0 to 26.0	23 days Interval 19.0 to 25.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Number of participants with mortality, adverse outcome-free days and transfusions in the patients with no severe traumatic brain injury (TBI) is defined as Abbreviated Injury Score (AIS) for Head/Neck \>=3.

Outcome measures

Outcome measures
Measure	Plasma n=52 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=45 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) 24-hour mortality	6 Participants	5 Participants
Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) Acute lung injury (ALI) within 28 days	20 Participants	21 Participants
Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) Required tranexamic acid (TXA) in first 6 h	5 Participants	6 Participants
Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) Required factor VII infusion in first 24 h	1 Participants	0 Participants
Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) Death or multiple organ failure within 28 days	9 Participants	6 Participants
Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) Possible transfusion associated acute lung injury	12 Participants	16 Participants
Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) Required red blood cell transfusion within 72 h	28 Participants	26 Participants
Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) Massive transf. (>=10 units of RBC or death/6 hrs	10 Participants	10 Participants
Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) 28-day mortality	6 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Number of participants with 28-day mortality. Traumatic brain injury (TBI) is defined as Abbreviated Injury Score (AIS) for Head/Neck \>=3.

Outcome measures

Outcome measures
Measure	Plasma n=13 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=15 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Exploratory Analyses in a Sub-group With Severe Traumatic Brain Injury (TBI)	4 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to day 28

Number of participants with severe adverse events (SAE)

Outcome measures

Outcome measures
Measure	Plasma n=75 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=69 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Severe Adverse Events (SAE) Any SAEs	34 Participants	24 Participants
Severe Adverse Events (SAE) Death	12 Participants	6 Participants
Severe Adverse Events (SAE) Infections	14 Participants	13 Participants
Severe Adverse Events (SAE) Thromboembolic events	4 Participants	2 Participants
Severe Adverse Events (SAE) Non-infectious and non-thromboembolic events	15 Participants	11 Participants
Severe Adverse Events (SAE) MOF (Denver MOF score>3)	5 Participants	1 Participants
Severe Adverse Events (SAE) Organ failure (not MOF)	15 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Population: Not all the timepoints are available for all the patients.

Haemoglobin (Hb) level in the patients with initial systolic blood pressure (SBP) \<=70 mmHg

Outcome measures

Outcome measures
Measure	Plasma n=44 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=33 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Haemoglobin (Hb) Level in a Sub-group With Severe Hemorrhagic Shock Admission (first arrival) Haemoglobin (Hb)	11.8 g/dL Interval 10.5 to 13.8	13.2 g/dL Interval 11.8 to 14.6
Haemoglobin (Hb) Level in a Sub-group With Severe Hemorrhagic Shock Lowest Haemoglobin (Hb) in first 6 hours	11.3 g/dL Interval 8.7 to 12.4	10.8 g/dL Interval 8.7 to 12.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Population: Not all the timepoints are available for all the patients.

Number of blood products transfused in units in the patients with initial systolic blood pressure (SBP) \<=70 mmHg

Outcome measures

Outcome measures
Measure	Plasma n=44 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=33 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock Cryoprecipitate transfused in 24 h	0 units Interval 0.0 to 0.0	0 units Interval 0.0 to 0.0
Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock Red blood cell (RBC) transfusion in 24 h	3.5 units Interval 0.0 to 13.5	3 units Interval 0.0 to 8.0
Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock Plasma transfused in 24h (excluding pre-admission)	1 units Interval 0.0 to 5.0	1 units Interval 0.0 to 3.0
Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock Platelets transfused in 24 h	0 units Interval 0.0 to 1.0	0 units Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Population: Not all the timepoints are available for all the patients.

Time to Admission and First Blood Transfusion in the patients with initial systolic blood pressure (SBP) \<=70 mmHg

Outcome measures

Outcome measures
Measure	Plasma n=44 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=33 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Time to Admission and First Blood Transfusion in a Sub-group With Severe Hemorrhagic Shock Time from injury to ED admission	28 minutes Interval 21.0 to 33.0	23 minutes Interval 19.0 to 28.0
Time to Admission and First Blood Transfusion in a Sub-group With Severe Hemorrhagic Shock Time from injury to first unit of RBC	48 minutes Interval 32.0 to 59.0	36 minutes Interval 30.0 to 44.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Haemoglobin (Hb) level in g/dL units.

Outcome measures

Outcome measures
Measure	Plasma n=65 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=60 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Haemoglobin (Hb) Level Admission (first arrival) Haemoglobin (Hb)	12.6 g/dL Interval 11.3 to 14.7	13.5 g/dL Interval 11.9 to 14.7
Haemoglobin (Hb) Level Lowest Haemoglobin (Hb) in first 6 hours	11.3 g/dL Interval 9.6 to 12.6	11 g/dL Interval 9.1 to 12.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Number of blood products transfused in units.

Outcome measures

Outcome measures
Measure	Plasma n=65 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=60 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Number of Blood Products Transfused. Red blood cell (RBC) transfusion in 24 h	2 units Interval 0.0 to 8.0	1.5 units Interval 0.0 to 8.0
Number of Blood Products Transfused. Plasma transfused in 24h (excluding pre-admission)	0 units Interval 0.0 to 4.0	0 units Interval 0.0 to 3.0
Number of Blood Products Transfused. Platelets transfused in 24 h	0 units Interval 0.0 to 0.0	0 units Interval 0.0 to 0.0
Number of Blood Products Transfused. Cryoprecipitate transfused in 24 h	0 units Interval 0.0 to 0.0	0 units Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay up to 28 days.

Time to admission and first blood product transfusion in minutes.

Outcome measures

Outcome measures
Measure	Plasma n=65 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=60 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Time to Admission and First Blood Transfusion Time from injury to first unit of RBC	46.5 minutes Interval 32.0 to 55.5	37 minutes Interval 24.0 to 46.0
Time to Admission and First Blood Transfusion Time from ED admission to first unit of RBC	16 minutes Interval 7.0 to 28.0	10 minutes Interval 4.0 to 18.0
Time to Admission and First Blood Transfusion Time to first plasma (including pre-admission)	24 minutes Interval 20.0 to 31.5	58.5 minutes Interval 40.0 to 115.0
Time to Admission and First Blood Transfusion Time from injury to ED admission	28 minutes Interval 22.0 to 34.0	24 minutes Interval 19.0 to 31.0
Time to Admission and First Blood Transfusion Time from admission to first platelet transfused	130 minutes Interval 91.0 to 222.0	88 minutes Interval 56.0 to 166.0

POST_HOC outcome

Timeframe: after injury and prior to hospital arrival, at about 15 minutes after injury

Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) activated clotting time (ACT).

Outcome measures

Outcome measures
Measure	Plasma n=43 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=37 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.	121 second Interval 113.0 to 128.0	121 second Interval 113.0 to 128.0

POST_HOC outcome

Timeframe: post-intervention and upon ED arrival

Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) activated clotting time (ACT) in seconds.

Outcome measures

Outcome measures
Measure	Plasma n=55 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=51 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.	128 second Interval 113.0 to 136.0	121 second Interval 113.0 to 136.0

POST_HOC outcome

Timeframe: after injury and prior to hospital arrival, at about 15 minutes after injury

Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) angle in degrees.

Outcome measures

Outcome measures
Measure	Plasma n=43 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=37 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.	70.6 degrees Interval 66.9 to 75.6	70.6 degrees Interval 66.1 to 74.3

POST_HOC outcome

Timeframe: after injury and prior to hospital arrival, at about 15 minutes after injury

Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) maximum amplitude (MA).

Outcome measures

Outcome measures
Measure	Plasma n=43 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=37 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.	62 millimeter (mm) Interval 57.5 to 68.0	63.5 millimeter (mm) Interval 58.0 to 67.0

POST_HOC outcome

Timeframe: after injury and prior to hospital arrival, at about 15 minutes after injury

Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG). Clot strength measured in kilodynes per square centimetre (kdyn/cm\^2).

Outcome measures

Outcome measures
Measure	Plasma n=43 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=37 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.	8.2 kdyn/cm^2 Interval 6.8 to 10.6	8.7 kdyn/cm^2 Interval 6.9 to 10.2

POST_HOC outcome

Timeframe: after injury and prior to hospital arrival, at about 15 minutes after injury

Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG). Percentage of clot lysis 30 minutes after maximal amplitude (MA) value is finalized.

Outcome measures

Outcome measures
Measure	Plasma n=43 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=37 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.	2.2 percentage of clot lysed at 30 minutes Interval 1.0 to 3.7	1.8 percentage of clot lysed at 30 minutes Interval 0.9 to 3.7

POST_HOC outcome

Timeframe: post-intervention and upon ED arrival

Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) angle measured in degrees.

Outcome measures

Outcome measures
Measure	Plasma n=55 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=51 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.	60.5 degree Interval 55.5 to 64.0	58.5 degree Interval 52.0 to 66.0

POST_HOC outcome

Timeframe: post-intervention and upon ED arrival

Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) maximal amplitude (MA).

Outcome measures

Outcome measures
Measure	Plasma n=55 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=51 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.	70.9 millimeter (mm) Interval 66.1 to 76.1	69.3 millimeter (mm) Interval 63.2 to 74.4

POST_HOC outcome

Timeframe: post-intervention and upon ED arrival

Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) clot strength measures by G value in kilodynes per square centimetre (kdyn/cm\^2).

Outcome measures

Outcome measures
Measure	Plasma n=55 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=51 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.	7.7 kdyn/cm^2 Interval 6.2 to 8.9	7.1 kdyn/cm^2 Interval 5.4 to 9.7

POST_HOC outcome

Timeframe: post-intervention and upon ED arrival

Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) clot lysis 30 minutes after the maximal amplitude (MA) was finalized.

Outcome measures

Outcome measures
Measure	Plasma n=55 Participants If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=51 Participants If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.	1.3 percentage of clot lysed at 30 minutes Interval 0.3 to 2.6	1.6 percentage of clot lysed at 30 minutes Interval 0.7 to 3.1

Adverse Events

Plasma

Serious events: 34 serious events

Other events: 5 other events

Deaths: 12 deaths

Standard

Serious events: 24 serious events

Other events: 2 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Plasma n=75 participants at risk If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=69 participants at risk If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Infections and infestations Infections	18.7% 14/75 • Number of events 23 • Hospital stay up to 28 days.	18.8% 13/69 • Number of events 20 • Hospital stay up to 28 days.
Vascular disorders DVTs and PEs	5.3% 4/75 • Number of events 4 • Hospital stay up to 28 days.	2.9% 2/69 • Number of events 2 • Hospital stay up to 28 days.
Renal and urinary disorders Acute kidney injury (AKI)	6.7% 5/75 • Number of events 5 • Hospital stay up to 28 days.	8.7% 6/69 • Number of events 6 • Hospital stay up to 28 days.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome (ARDS)	26.7% 20/75 • Number of events 20 • Hospital stay up to 28 days.	20.3% 14/69 • Number of events 14 • Hospital stay up to 28 days.
Hepatobiliary disorders Liver failure	5.3% 4/75 • Number of events 4 • Hospital stay up to 28 days.	5.8% 4/69 • Number of events 4 • Hospital stay up to 28 days.
Cardiac disorders Cardiac	9.3% 7/75 • Number of events 7 • Hospital stay up to 28 days.	8.7% 6/69 • Number of events 6 • Hospital stay up to 28 days.
Endocrine disorders Adrenal insufficiency	1.3% 1/75 • Number of events 1 • Hospital stay up to 28 days.	0.00% 0/69 • Hospital stay up to 28 days.
Gastrointestinal disorders GI bleed	2.7% 2/75 • Number of events 2 • Hospital stay up to 28 days.	0.00% 0/69 • Hospital stay up to 28 days.
Skin and subcutaneous tissue disorders Hematoma	1.3% 1/75 • Number of events 1 • Hospital stay up to 28 days.	0.00% 0/69 • Hospital stay up to 28 days.
Surgical and medical procedures Hemorrhage	2.7% 2/75 • Number of events 2 • Hospital stay up to 28 days.	0.00% 0/69 • Hospital stay up to 28 days.

Other adverse events

Other adverse events
Measure	Plasma n=75 participants at risk If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario. Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.	Standard n=69 participants at risk If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario. Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Psychiatric disorders Intensive Care Unit (ICU) delirium	4.0% 3/75 • Hospital stay up to 28 days.	2.9% 2/69 • Hospital stay up to 28 days.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	1.3% 1/75 • Hospital stay up to 28 days.	0.00% 0/69 • Hospital stay up to 28 days.
Nervous system disorders Facial paralysis	1.3% 1/75 • Hospital stay up to 28 days.	0.00% 0/69 • Hospital stay up to 28 days.

Additional Information

Dr. Ernest E. Moore

Denver Health Medical Center

Phone: 303.602.1820

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place