Trial Outcomes & Findings for Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients (NCT NCT05081063)

Results Overview

assessment of pRBC equivalents transfused in each arm, an increase in HGB by 1g/dl per unit transfused will be considered successful A blood draw of 5ml will be obtained and tested to assess HGB level. An increase in HGB by 1g/dl per unit transfused will be considered a successful result.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

199 participants

Primary outcome timeframe

The total transfusion requirement of packed red blood cells was analyzed for the duration of the inpatient hospitalization for patients surviving at least 24 hours. This time is defined as a time period up to 30 days.

Results posted on

2025-08-08

Participant Flow

Male highest-tier trauma activations randomized in 24 hour blocks

Participant milestones

Participant milestones
Measure	Low Titer O+ Whole Blood Low Titer O+ Whole blood provided to Level A trauma patients	Component Therapy Component Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas
Overall Study STARTED	52	147
Overall Study COMPLETED	52	147
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Titer O+ Whole Blood n=52 Participants Low Titer O+ Whole blood provided to Level A trauma patients	Component Therapy n=147 Participants Component Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas	Total n=199 Participants Total of all reporting groups
Age, Continuous	39.9 years STANDARD_DEVIATION 13.6 • n=52 Participants	42.1 years STANDARD_DEVIATION 16.9 • n=147 Participants	41.5 years STANDARD_DEVIATION 16.1 • n=199 Participants
Sex: Female, Male Female	0 Participants n=52 Participants	0 Participants n=147 Participants	0 Participants n=199 Participants
Sex: Female, Male Male	52 Participants n=52 Participants	147 Participants n=147 Participants	199 Participants n=199 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Injury severity score	19.6 units on a scale STANDARD_DEVIATION 11.7 • n=52 Participants	19.3 units on a scale STANDARD_DEVIATION 12.2 • n=147 Participants	19.4 units on a scale STANDARD_DEVIATION 12.0 • n=199 Participants
Glasgow Coma Scale in ED	13.5 units on a scale n=52 Participants	14.0 units on a scale n=147 Participants	14 units on a scale n=199 Participants
First systolic blood pressure in ED	91.2 mm Hg STANDARD_DEVIATION 50.4 • n=52 Participants	98.4 mm Hg STANDARD_DEVIATION 44.6 • n=147 Participants	96.5 mm Hg STANDARD_DEVIATION 46.2 • n=199 Participants

PRIMARY outcome

Timeframe: The total transfusion requirement of packed red blood cells was analyzed for the duration of the inpatient hospitalization for patients surviving at least 24 hours. This time is defined as a time period up to 30 days.

Population: Population of patients surviving 24 hours analyzed for transfusion measures

assessment of pRBC equivalents transfused in each arm, an increase in HGB by 1g/dl per unit transfused will be considered successful A blood draw of 5ml will be obtained and tested to assess HGB level. An increase in HGB by 1g/dl per unit transfused will be considered a successful result.

Outcome measures

Outcome measures
Measure	Low Titer O+ Whole Blood n=40 Participants Low Titer O+ Whole blood provided to Level A trauma patients	Component Therapy n=123 Participants Component Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas
Packed Red Blood Cells Equivalents Units Transfused (1 Whole Blood Unit Treated as 1 Packed Red Blood Cell Unit and 1 Fresh Frozen Plasma Unit)	3.8 units Standard Deviation 5.6	5.7 units Standard Deviation 6.2

SECONDARY outcome

Timeframe: In patients surviving at least 24 hours who were included in analysis of outcome measures, we assessed survival to hospital discharge. This means the duration of time in the hospital up to discharge with a maximum of 30 days.

Assessment of mortality This is a composite measurement which includes the following in order to be assessed as pulseless with no respiratory drive or brain death: 1. there is no evidence of arousal or awareness to maximal external stimuli 2. pupils are fixed in a midsized or dilated position and non reactive to light 3. corneal, oculocephalic and oculovestibular reflexes are absent 4. There is no facial movement to noxious stimuli 5. the gag reflex is absent to bilateral posterior pharyngeal stimuli 6. the cough reflex is absent to deep tracheal suctioning 7. there is no brain mediated motor response to noxious stimuli of the limbs 8. spontaneous respirations are not observed when apnea test targets reach pH \<7.30 and PaCO2 \>60mmhg

Outcome measures

Outcome measures
Measure	Low Titer O+ Whole Blood n=40 Participants Low Titer O+ Whole blood provided to Level A trauma patients	Component Therapy n=123 Participants Component Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas
Mortality	4 Participants	13 Participants

Adverse Events

Low Titer O+ Whole Blood

Serious events: 0 serious events

Other events: 0 other events

Deaths: 17 deaths

Component Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 37 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kaushik Mukherjee

Loma Linda University Health

Phone: 9096515948

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place