A Phase 3 interventional study of Routine labs in Hemorrhagic Shock, Acute Blood Loss Anemia and Traumatic Brain Injury, sponsored by Loma Linda University. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Loma Linda University · Phase 3, Interventional, and Treatment
Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion.
Objectives
Based on the results from Cotton et al, median transfusion in the component therapy group was 6 PRBC in the first 24 hours and 4 PRBC equivalents in the whole blood group. The standard deviation (estimated from the interquartile range) was approximately 4. Thus with an expectation of alpha = 0.05 and expected power of 90% to detect a similar 2 unit difference in transfusion volume, a sample size of 190 should be sufficient; thus projected sample size of 200 should be more than adequate. Age range will be 18 years and older, and only males will be included in the study. Expected racial/ethnic distribution will be approximately 60% white, 15% black, 8% Asian, and 18% other race. No actual recruitment will be performed; rather all qualifying patients will be included. Consent waiver is being requested.
b. Objectives
1. ICU length of stay 2. Ventilator days 3. SOFA score on day of ICU discharge 4. Presence of ARDS 5. Presence of TRALI 6. Presence of DVT/PE 7. Necessity for Dialysis 8. Necessity for Tracheostomy 9. Evaluate viscoelastic testing parameters in both groups when sent on arrival in ICU
1. Percentage of patients with EXTEM clotting time > 80 sec 2. Percentage of patients with EXTEM amplitude at 10 min \< 40mm and FIBTEM amplitude at 10 min ≤ 10mm 3. Percentage of patients with EXTEM amplitude at 10 min \< 40mm and FIBTEM amplitude at 10 min > 10mm 4. Percentage of patients with maximum thrombolysis > 15% 5. Interval analyses to be performed after 6 and 12 months with provision to continue the study out to 24 months.
1. Stopping rule: A statistically significant difference in hospital mortality at 6 months or 12 months
78 studies on the registry are indexed under Shock, Hemorrhagic; 17 are open to participants now.
This study's enrollment of 199 is above the median of 100 across 39 interventional studies indexed under Shock, Hemorrhagic.
Browse Shock, Hemorrhagic studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low Titer O+ Whole blood provided to Level A trauma patients
Combination Product: Routine labs
Component Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas
Combination Product: Routine labs
Routine labs will be performed with CBC, BMP, Fox screen, ROTEM viscoelastic test, PT/INR, PTT and venous lactate for standard of care for all patients.
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)
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.
Time frame: 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.
Mortality
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
Time frame: 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.
Male highest-tier trauma activations randomized in 24 hour blocks
| Milestone | Low Titer O+ Whole Blood | Component Therapy |
|---|---|---|
| Started | 52 | 147 |
| Completed | 52 | 147 |
| Not completed | 0 | 0 |
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.
| units | Low Titer O+ Whole Blood | Component Therapy |
|---|---|---|
| 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 ± 5.6 | 5.7 ± 6.2 |
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
| Participants | Low Titer O+ Whole Blood | Component Therapy |
|---|---|---|
| Mortality | 4 | 13 |
Collected over Adverse event data was collected through hospital discharge, meaning the duration of time in the hospital after the injury up to 30 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Titer O+ Whole Blood | 17/52 (32.7%) | 0/52 (0%) | 0/52 (0%) |
| Component Therapy | 37/147 (25.2%) | 0/147 (0%) | 0/147 (0%) |
This population was all male given the safety constraints listed in the protocol. Baseline data was only collected for patients that survived 24 hours as this was the analyzed group as specified in the protocol.
| Age, Continuous(years) | Low Titer O+ Whole Blood | Component Therapy | Total |
|---|---|---|---|
| Mean | 39.9 ± 13.6 | 42.1 ± 16.9 | 41.5 ± 16.1 |
| Sex: Female, Male(Participants) | Low Titer O+ Whole Blood | Component Therapy | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 52 | 147 | 199 |
| Race and Ethnicity Not Collected(Participants) | Low Titer O+ Whole Blood | Component Therapy | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Injury severity score(units on a scale) | Low Titer O+ Whole Blood | Component Therapy | Total |
|---|---|---|---|
| Mean | 19.6 ± 11.7 | 19.3 ± 12.2 | 19.4 ± 12.0 |
| Glasgow Coma Scale in ED(units on a scale) | Low Titer O+ Whole Blood | Component Therapy | Total |
|---|---|---|---|
| Median | 13.5 (3 to 15) | 14.0 (3 to 15) | 14 (3 to 15) |
| First systolic blood pressure in ED(mm Hg) | Low Titer O+ Whole Blood | Component Therapy | Total |
|---|---|---|---|
| Mean | 91.2 ± 50.4 | 98.4 ± 44.6 | 96.5 ± 46.2 |
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