Trial Outcomes & Findings for Pragmatic, Randomized Optimal Platelet and Plasma Ratios (NCT NCT01545232)

NCT ID: NCT01545232

Last Updated: 2019-02-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 680 participants
• Primary outcome timeframe: First 24 hours after ED admission
• Results posted on: 2019-02-08

Participant Flow

Participant milestones

Measure	1:1:1 Blood Transfusion Ratio 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Overall Study STARTED	338	342
Overall Study COMPLETED	338	342
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pragmatic, Randomized Optimal Platelet and Plasma Ratios

Baseline characteristics by cohort

Measure	1:1:1 Blood Transfusion Ratio n=338 Participants 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=342 Participants 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.	Total n=680 Participants Total of all reporting groups
Age, Customized	338 participants n=5 Participants	342 participants n=7 Participants	680 participants n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	59 Participants n=7 Participants	134 Participants n=5 Participants
Sex: Female, Male Male	263 Participants n=5 Participants	283 Participants n=7 Participants	546 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	61 Participants n=5 Participants	59 Participants n=7 Participants	120 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	277 Participants n=5 Participants	283 Participants n=7 Participants	560 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants	8 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	93 Participants n=5 Participants	93 Participants n=7 Participants	186 Participants n=5 Participants
Race (NIH/OMB) White	210 Participants n=5 Participants	224 Participants n=7 Participants	434 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: First 24 hours after ED admission

Population: Number of subjects who were randomized to each group

Outcome measures

Measure	1:1:1 Blood Transfusion Ratio n=338 Participants 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=342 Participants 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
24-hour Mortality	43 participants	58 participants

PRIMARY outcome

Timeframe: First 30 days after ED admission

Population: Number of subjects enrolled into each group.

Outcome measures

Measure	1:1:1 Blood Transfusion Ratio n=338 Participants 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=342 Participants 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
30-day Mortality	75 participants	89 participants

PRIMARY outcome

Timeframe: From time of ED admission, for up to 72 hours

Population: Number of subjects who were randomized to each group

Blood samples were collected at time of ED admission and over time to determine the incidence of reported venous thrombolic events (VTE).

Outcome measures

Measure	1:1:1 Blood Transfusion Ratio n=338 Participants 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=342 Participants 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE)	45 participants	42 participants

SECONDARY outcome

Timeframe: first 30 days after ED admission

Population: Number of hospital free days for each group.

Outcome measures

Measure	1:1:1 Blood Transfusion Ratio n=338 Participants 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=342 Participants 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Hospital Free Days	1 days Interval 0.0 to 17.0	0 days Interval 0.0 to 16.0

SECONDARY outcome

Timeframe: ED admission to hospital discharge or 30 days, whichever comes first

Population: Time to anatomic hemostasis

Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department (ED) arrival.

Outcome measures

Measure	1:1:1 Blood Transfusion Ratio n=338 Participants 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=342 Participants 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Time to Hemostasis	105 minutes Interval 64.0 to 179.0	100 minutes Interval 56.0 to 181.0

SECONDARY outcome

Timeframe: 24 hours from randomization

Outcome measures

Measure	1:1:1 Blood Transfusion Ratio n=338 Participants 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=342 Participants 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Amount of Randomized Blood Products Given to Hemostasis	16 units of blood products Interval 10.0 to 32.0	15 units of blood products Interval 5.0 to 24.0

SECONDARY outcome

Timeframe: Hospital discharge or 30 days, whichever comes first

Population: Glasgow Outcome Extended Score (GOSE) Score on discharged patients who had a head injury (Abbreviated Injury Score (AIS) \> 1) ranging from 1 to 8. The AIS is a coding scale to classify the injury severity. A score is created for each body region, type of anatomic structure (i.e. whole area, vessels,organs), and severity(minor to maximum).

The Glasgow Outcome Extended Score (GOSE) is a tool used to measure recovery following brain injury and assists with prediction of long-term rehabilitation. The 8 scoring categories are death, vegetative state, lower severe disability, upper severe disability, lower moderate disability, upper moderate disability, lower good recovery and upper good recovery. A higher GOSE score correlates with better outcome.

Outcome measures

Measure	1:1:1 Blood Transfusion Ratio n=30 Participants 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=28 Participants 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Functional Status at Time of Hospital Discharge	4 units on the GOSE scale Interval 3.0 to 6.0	4.5 units on the GOSE scale Interval 3.5 to 7.0

SECONDARY outcome

Timeframe: ED admission to hospital discharge or 30 days, whichever comes first

Population: Incidence of primary surgical procedure

Outcome measures

Measure	1:1:1 Blood Transfusion Ratio n=338 Participants 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=342 Participants 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Incidence of Primary Surgical Procedure	290 participants	284 participants

SECONDARY outcome

Timeframe: ED admission to hospital discharge or 30 days, whichever comes first

Population: Incidence of transfusion related serious adverse events-Reportable to FDA

Outcome measures

Measure	1:1:1 Blood Transfusion Ratio n=338 Participants 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=342 Participants 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Incidence of Transfusion Related Serious Adverse Events	1 participants	0 participants

SECONDARY outcome

Timeframe: Hospital discharge or 30 days, whichever comes first

Population: Disposition of subject at time of hospital discharge

Outcome measures

Measure	1:1:1 Blood Transfusion Ratio n=338 Participants 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=342 Participants 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Initial Hospital Discharge Status Home	118 participants	105 participants
Initial Hospital Discharge Status Remained hospitalized at 30 days	82 participants	77 participants
Initial Hospital Discharge Status Other	59 participants	71 participants
Initial Hospital Discharge Status Morgue	75 participants	89 participants
Initial Hospital Discharge Status Unknown	4 participants	0 participants

SECONDARY outcome

Timeframe: first 30 days after ED admission

Population: Number of ventilator free days for each group.

Outcome measures

Measure	1:1:1 Blood Transfusion Ratio n=338 Participants 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=342 Participants 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Ventilator Free Days	8 days Interval 0.0 to 16.0	7 days Interval 0.0 to 14.0

SECONDARY outcome

Timeframe: first 30 days after ED admission

Population: Number of ICU free days for each group.

Outcome measures

Measure	1:1:1 Blood Transfusion Ratio n=338 Participants 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=342 Participants 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
ICU Free Days	5 days Interval 0.0 to 11.0	4 days Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 24 hours after ED admission

Population: Unit of measure for outcome measures below is median number of blood product units that given in each group (1:1:1 or 1:1:2) from time initial hemostasis was complete (PROPPR randomized study products stopped) up to 24 hours following ED admission. Number of participants is based on those who survived up to 24 hours, not participants randomized.

Outcome measures

Measure	1:1:1 Blood Transfusion Ratio n=316 Participants 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=305 Participants 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Amount of Blood Products Given From Hemostasis to 24 Hours After ED Admission	1 units of blood products Interval 0.0 to 6.0	2 units of blood products Interval 0.0 to 9.0

Adverse Events

1:1:1 Blood Transfusion Ratio

Serious events: 2 serious events

Other events: 297 other events

Deaths: 0 deaths

1:1:2 Blood Transfusion Ratio

Serious events: 4 serious events

Other events: 310 other events

Deaths: 0 deaths

Serious adverse events

Measure	1:1:1 Blood Transfusion Ratio n=338 participants at risk 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=342 participants at risk 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Cardiac disorders Transfusion-associated circulatory overload	0.30% 1/338 • Number of events 1 • up to 30 days following ED admission	0.00% 0/342 • up to 30 days following ED admission
Metabolism and nutrition disorders Hypernatremia associated with hypertonic saline use	0.30% 1/338 • Number of events 1 • up to 30 days following ED admission	1.2% 4/342 • Number of events 4 • up to 30 days following ED admission

Other adverse events

Measure	1:1:1 Blood Transfusion Ratio n=338 participants at risk 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.	1:1:2 Blood Transfusion Ratio n=342 participants at risk 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
General disorders Systemic inflammatory response syndrome	68.3% 231/338 • Number of events 265 • up to 30 days following ED admission	63.2% 216/342 • Number of events 239 • up to 30 days following ED admission
Infections and infestations Sepsis	29.3% 99/338 • Number of events 110 • up to 30 days following ED admission	26.6% 91/342 • Number of events 102 • up to 30 days following ED admission
Infections and infestations Infection	29.0% 98/338 • Number of events 155 • up to 30 days following ED admission	31.0% 106/342 • Number of events 146 • up to 30 days following ED admission
Renal and urinary disorders Acute Kidney Injury	21.9% 74/338 • Number of events 87 • up to 30 days following ED admission	24.9% 85/342 • Number of events 93 • up to 30 days following ED admission
Infections and infestations Ventilator-associated pneumonia	18.3% 62/338 • Number of events 70 • up to 30 days following ED admission	17.0% 58/342 • Number of events 65 • up to 30 days following ED admission
Metabolism and nutrition disorders Transfusion-related metabolic complications	15.7% 53/338 • Number of events 53 • up to 30 days following ED admission	17.3% 59/342 • Number of events 60 • up to 30 days following ED admission
Respiratory, thoracic and mediastinal disorders Acute Lung Injury	13.9% 47/338 • Number of events 56 • up to 30 days following ED admission	16.7% 57/342 • Number of events 66 • up to 30 days following ED admission
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	13.6% 46/338 • Number of events 55 • up to 30 days following ED admission	14.0% 48/342 • Number of events 57 • up to 30 days following ED admission
Vascular disorders Deep Vein Thrombosis	7.4% 25/338 • Number of events 28 • up to 30 days following ED admission	7.0% 24/342 • Number of events 24 • up to 30 days following ED admission
General disorders Abdominal Complication	7.1% 24/338 • Number of events 29 • up to 30 days following ED admission	6.4% 22/342 • Number of events 23 • up to 30 days following ED admission
Cardiac disorders Cardiac arrest	6.8% 23/338 • Number of events 25 • up to 30 days following ED admission	7.9% 27/342 • Number of events 30 • up to 30 days following ED admission
General disorders Multiple Organ Failure	5.9% 20/338 • Number of events 24 • up to 30 days following ED admission	4.4% 15/342 • Number of events 18 • up to 30 days following ED admission
Respiratory, thoracic and mediastinal disorders Symptomatic pulmonary embolism	4.1% 14/338 • Number of events 14 • up to 30 days following ED admission	3.8% 13/342 • Number of events 13 • up to 30 days following ED admission
General disorders Additional bleeding after hemostasis requiring intervention	3.8% 13/338 • Number of events 13 • up to 30 days following ED admission	4.7% 16/342 • Number of events 18 • up to 30 days following ED admission
Respiratory, thoracic and mediastinal disorders Asymptomatic pulmonary embolism	3.3% 11/338 • Number of events 11 • up to 30 days following ED admission	3.2% 11/342 • Number of events 11 • up to 30 days following ED admission
Nervous system disorders Stroke	2.4% 8/338 • Number of events 9 • up to 30 days following ED admission	3.2% 11/342 • Number of events 11 • up to 30 days following ED admission
General disorders Abdominal Compartment syndrome	0.89% 3/338 • Number of events 3 • up to 30 days following ED admission	0.88% 3/342 • Number of events 3 • up to 30 days following ED admission
Immune system disorders Delayed serological transfusion reaction	0.59% 2/338 • Number of events 2 • up to 30 days following ED admission	0.00% 0/342 • up to 30 days following ED admission
General disorders Transfusion-related allergic reaction	0.59% 2/338 • Number of events 2 • up to 30 days following ED admission	0.29% 1/342 • Number of events 1 • up to 30 days following ED admission
Immune system disorders Febrile nonhemolytic transfusion reaction	0.30% 1/338 • Number of events 1 • up to 30 days following ED admission	0.29% 1/342 • Number of events 1 • up to 30 days following ED admission
Cardiac disorders Myocardial Infarction	0.00% 0/338 • up to 30 days following ED admission	0.58% 2/342 • Number of events 2 • up to 30 days following ED admission

Additional Information

John Holcomb, M.D.

University of Texas Health Science Center - Houston

Phone: 713-500-5493

Email: John.Holcomb@uth.tmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place