Trial Outcomes & Findings for Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation (NCT NCT04704869)
NCT ID: NCT04704869
Last Updated: 2025-01-14
Results Overview
Mortality from any cause
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1604 participants
Primary outcome timeframe
28 days after emergency department (ED) admission
Results posted on
2025-01-14
Participant Flow
Participant milestones
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
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|---|---|---|
|
Overall Study
STARTED
|
805
|
799
|
|
Overall Study
Completed 28-day Follow up
|
771
|
760
|
|
Overall Study
COMPLETED
|
771
|
760
|
|
Overall Study
NOT COMPLETED
|
34
|
39
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
Baseline characteristics by cohort
| Measure |
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=799 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=805 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Total
n=1604 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
n=785 Participants • Age data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
40 years
n=796 Participants • Age data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
39 years
n=1581 Participants • Age data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
|
Sex: Female, Male
Female
|
167 Participants
n=785 Participants • Sex data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
163 Participants
n=796 Participants • Sex data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
330 Participants
n=1581 Participants • Sex data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
|
Sex: Female, Male
Male
|
618 Participants
n=785 Participants • Sex data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
633 Participants
n=796 Participants • Sex data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
1251 Participants
n=1581 Participants • Sex data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=24 Participants • Ethnicity data were only collected from 48 US participants.
|
1 Participants
n=24 Participants • Ethnicity data were only collected from 48 US participants.
|
1 Participants
n=48 Participants • Ethnicity data were only collected from 48 US participants.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=24 Participants • Ethnicity data were only collected from 48 US participants.
|
14 Participants
n=24 Participants • Ethnicity data were only collected from 48 US participants.
|
30 Participants
n=48 Participants • Ethnicity data were only collected from 48 US participants.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=24 Participants • Ethnicity data were only collected from 48 US participants.
|
9 Participants
n=24 Participants • Ethnicity data were only collected from 48 US participants.
|
17 Participants
n=48 Participants • Ethnicity data were only collected from 48 US participants.
|
|
Race/Ethnicity, Customized
Race · Black
|
10 Participants
n=24 Participants • Race data were only collected from 48 US participants.
|
6 Participants
n=24 Participants • Race data were only collected from 48 US participants.
|
16 Participants
n=48 Participants • Race data were only collected from 48 US participants.
|
|
Race/Ethnicity, Customized
Race · White
|
5 Participants
n=24 Participants • Race data were only collected from 48 US participants.
|
8 Participants
n=24 Participants • Race data were only collected from 48 US participants.
|
13 Participants
n=48 Participants • Race data were only collected from 48 US participants.
|
|
Race/Ethnicity, Customized
Race · Other
|
9 Participants
n=24 Participants • Race data were only collected from 48 US participants.
|
10 Participants
n=24 Participants • Race data were only collected from 48 US participants.
|
19 Participants
n=48 Participants • Race data were only collected from 48 US participants.
|
|
Region of Enrollment
United States
|
24 participants
n=799 Participants
|
25 participants
n=805 Participants
|
48 participants
n=1604 Participants
|
|
Region of Enrollment
United Kingdom
|
775 participants
n=799 Participants
|
780 participants
n=805 Participants
|
1555 participants
n=1604 Participants
|
|
Time from injury to ED arrival
|
75 minutes
n=799 Participants
|
77 minutes
n=805 Participants
|
76 minutes
n=1604 Participants
|
|
Number of Participants who arrived at the Emergency Department with a blunt injury
|
495 Participants
n=785 Participants • Number of participants who arrived in the Emergency Department with a blunt injury data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
519 Participants
n=796 Participants • Number of participants who arrived in the Emergency Department with a blunt injury data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
1014 Participants
n=1581 Participants • Number of participants who arrived in the Emergency Department with a blunt injury data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
|
Number of Participants who arrived to the Emergency Department in cardiac arrest
|
12 Participants
n=717 Participants • Number of participants who arrived to the Emergency Department in cardiac arrest were not be collected for 70 in the Massive Transfusion Protocol arm and for 82 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
17 Participants
n=735 Participants • Number of participants who arrived to the Emergency Department in cardiac arrest were not be collected for 70 in the Massive Transfusion Protocol arm and for 82 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
29 Participants
n=1452 Participants • Number of participants who arrived to the Emergency Department in cardiac arrest were not be collected for 70 in the Massive Transfusion Protocol arm and for 82 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.
|
PRIMARY outcome
Timeframe: 28 days after emergency department (ED) admissionPopulation: Vital status was not available from any source for 34 in the Massive Transfusion Protocol arm and 39 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm. Data presented are from an intention to treat analysis.
Mortality from any cause
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=771 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=760 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Number of Participants With Mortality From Any Cause
|
201 Participants
|
192 Participants
|
SECONDARY outcome
Timeframe: 6 hours after ED admissionPopulation: Data were not collected for 15 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected for 10 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
Mortality from any cause
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=784 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=795 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
All Cause Mortality at 6 Hours
|
56 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: 24 hours after ED admissionPopulation: Data were not collected for 16 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected for 11 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm
Mortality from any cause
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=783 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=794 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
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|---|---|---|
|
All Cause Mortality at 24 Hours
|
88 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: 6 months after ED admissionMortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated.
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=799 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=805 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
All Cause Mortality at 6 Months
|
26.1 percentage of participants
Interval 23.2 to 29.4
|
27.3 percentage of participants
Interval 24.3 to 30.7
|
SECONDARY outcome
Timeframe: 12 months after ED admissionMortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated.
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=799 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=805 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
All Cause Mortality at 12 Months
|
26.6 percentage of participants
Interval 23.6 to 30.0
|
27.7 percentage of participants
Interval 24.6 to 31.1
|
SECONDARY outcome
Timeframe: 6 hours after ED admissionPopulation: Data were not collected from 10 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 15 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
Death related to exsanguination
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=784 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=795 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Death From Bleeding at 6 Hours
|
32 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 24 hours after ED admissionPopulation: Data were not collected from 11 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 16 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
Death related to exsanguination
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=783 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=794 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Death From Bleeding at 24 Hours
|
43 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hoursPopulation: Data were not collected from 108 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
Number of units of RBCs
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=695 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=697 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Transfusion Requirements (Number of Units of Red Blood Cells (RBCs))
|
5 Units
Interval 3.0 to 9.0
|
5 Units
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hoursPopulation: Data were not collected from 108 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
Number of units of plasma
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=695 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=697 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Transfusion Requirements (Number of Units of Plasma)
|
4 units
Interval 2.0 to 8.0
|
4 units
Interval 2.0 to 8.0
|
SECONDARY outcome
Timeframe: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hoursPopulation: Data were not collected from 110 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
Number of units of platelets
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=695 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=695 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Transfusion Requirements (Number of Units of Platelets)
|
0 Units
Interval 0.0 to 1.0
|
0 Units
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hoursPopulation: Data were not collected from 110 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
Number of units of cryoprecipitate
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=695 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=695 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Transfusion Requirements (Number of Units of Cryoprecipitate)
|
3 Units
Interval 3.0 to 3.0
|
0 Units
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: at the time of discharge from hospital, about 11-27 days after admissionPopulation: Data were not collected from 431 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 424 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
Destination of participant at time of discharge from hospital
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=375 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=374 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Destination of Participant at Time of Discharge From Hospital
Home
|
280 Participants
|
278 Participants
|
|
Destination of Participant at Time of Discharge From Hospital
Nursing home/rehabilitation facility
|
9 Participants
|
8 Participants
|
|
Destination of Participant at Time of Discharge From Hospital
Other hospital
|
63 Participants
|
72 Participants
|
|
Destination of Participant at Time of Discharge From Hospital
Other
|
23 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day of hospital discharge or 28 days after ED admission (whichever comes first)Population: Data were not collected from 458 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 475 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
The 5-level EQ-5D version (EQ-5D-5L) score range was -0.148 (worst health state) to 0.949 (best health state). A higher score indicating a better health state.
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=324 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=347 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)
|
0.51 score on a scale
Interval 0.26 to 0.72
|
0.50 score on a scale
Interval 0.2 to 0.73
|
SECONDARY outcome
Timeframe: Day of hospital discharge or 28 days after ED admission (whichever comes first)Population: Data were not collected from 93 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 94 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
The Glasgow Outcome Score ranges from 1 to 5, with a higher score indicating a better outcome: 1. Death - Severe injury or death without recovery of consciousness 2. Persistent vegetative state - Severe damage with prolonged state of unresponsiveness and a lack of higher mental functions 3. Severe disability - Severe injury with permanent need for help with daily living 4. Moderate disability - No need for assistance in everyday life, employment is possible but may require special equipment 5. Low disability - Light damage with minor neurological and psychological deficits
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=705 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=712 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Quality of Life as Assessed by the Glasgow Outcome Score
Low disability
|
226 Participants
|
221 Participants
|
|
Quality of Life as Assessed by the Glasgow Outcome Score
Moderate disability
|
129 Participants
|
129 Participants
|
|
Quality of Life as Assessed by the Glasgow Outcome Score
Severe disability
|
155 Participants
|
153 Participants
|
|
Quality of Life as Assessed by the Glasgow Outcome Score
Persistent vegetative state
|
21 Participants
|
27 Participants
|
|
Quality of Life as Assessed by the Glasgow Outcome Score
Death
|
174 Participants
|
182 Participants
|
SECONDARY outcome
Timeframe: 6 months after ED admissionPopulation: Data were not collected from 350 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 331 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
The 5-level EQ-5D version (EQ-5D-5L) score range was -0.148 (worst health state) to 0.949 (best health state). A higher score indicating a better health state.
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=468 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=455 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)
|
0.76 score on a scale
Interval 0.63 to 0.93
|
0.66 score on a scale
Interval 0.36 to 0.78
|
SECONDARY outcome
Timeframe: 6 months after ED admissionPopulation: Data for this outcome measure were not collected because the survey was not included on the 6-month follow-up. As a result, no participants received the survey, and therefore, no participants were analyzed in either study arm.
The Glasgow Outcome Score ranges from 1 to 5, with a higher score indicating a better outcome: 1. Death - Severe injury or death without recovery of consciousness 2. Persistent vegetative state - Severe damage with prolonged state of unresponsiveness and a lack of higher mental functions 3. Severe disability - Severe injury with permanent need for help with daily living 4. Moderate disability - No need for assistance in everyday life, employment is possible but may require special equipment 5. Low disability - Light damage with minor neurological and psychological deficits
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day of hospital discharge or 28 days after ED admission (whichever comes first)Population: Data were not collected from 34 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
Number of ventilator days during hospitalization
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=763 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=771 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Hospital Resource Use as Assessed by Number of Ventilator Days
|
1 days
Interval 0.0 to 6.0
|
1 days
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Day of hospital discharge or 28 days after ED admission (whichever comes first)Population: Data were not collected from 34 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
Number of ICU days during hospitalization
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=763 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=771 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Hospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) Days
|
4 days
Interval 1.0 to 12.0
|
4 days
Interval 1.0 to 13.0
|
SECONDARY outcome
Timeframe: Day of hospital discharge or 28 days after ED admission (whichever comes first)Population: Data were not collected from 33 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
Total number of hospital days
Outcome measures
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=763 Participants
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=772 Participants
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Hospital Resource Use as Assessed by Number of Hospital Days
|
11 days
Interval 3.0 to 27.0
|
11 days
Interval 3.0 to 27.0
|
Adverse Events
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
Serious events: 83 serious events
Other events: 0 other events
Deaths: 201 deaths
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
Serious events: 84 serious events
Other events: 0 other events
Deaths: 192 deaths
Serious adverse events
| Measure |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=805 participants at risk
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
n=799 participants at risk
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
|
|---|---|---|
|
Vascular disorders
Venous thromboembolism
|
7.1%
57/805 • Number of events 59 • Day of hospital discharge or 28 days after ED admission (whichever comes first)
28-day vital status was not available from any source for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm; therefore, all-Cause Mortality data could not be assessed for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm.
|
6.9%
55/799 • Number of events 58 • Day of hospital discharge or 28 days after ED admission (whichever comes first)
28-day vital status was not available from any source for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm; therefore, all-Cause Mortality data could not be assessed for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm.
|
|
Vascular disorders
Arterial thrombotic event
|
3.2%
26/805 • Number of events 26 • Day of hospital discharge or 28 days after ED admission (whichever comes first)
28-day vital status was not available from any source for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm; therefore, all-Cause Mortality data could not be assessed for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm.
|
3.3%
26/799 • Number of events 27 • Day of hospital discharge or 28 days after ED admission (whichever comes first)
28-day vital status was not available from any source for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm; therefore, all-Cause Mortality data could not be assessed for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm.
|
|
General disorders
Serious transfusion related adverse event
|
0.00%
0/805 • Day of hospital discharge or 28 days after ED admission (whichever comes first)
28-day vital status was not available from any source for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm; therefore, all-Cause Mortality data could not be assessed for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm.
|
0.38%
3/799 • Number of events 3 • Day of hospital discharge or 28 days after ED admission (whichever comes first)
28-day vital status was not available from any source for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm; therefore, all-Cause Mortality data could not be assessed for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm.
|
Other adverse events
Adverse event data not reported
Additional Information
Bryan A Cotton, MD
The University of Texas Health Science Center at Houston
Phone: 713-500-7313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place