Hemorrhagic ShockPhase 3NCT05081063

Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients

A Phase 3 study testing Routine labs in people with Hemorrhagic Shock and Acute Blood Loss Anemia, run by Loma Linda University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion. Objectives 1. Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome) 2. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Hemorrhagic Shock, Acute Blood Loss Anemia, Traumatic Brain Injury
What is being tested?: Routine labs
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 199 participants
Where: 1 siteUnited States
Study dates: 5 Mar 2022to 15 May 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

all adult male patients brought into the emergency department as LEVEL A trauma activations who are receiving emergency blood transfusions

Who cannot join

Female patients (specifically excluded due to risk of alloimmunization of Rh-negative female patients of childbearing age against Rh-positive blood)
children
prisoners
all patients classified as dead upon arrival to the trauma bay

Trial locations and contacts

1 site in 1 country.

United States1 site

Loma Linda University Health
Loma Linda, California, 92354

Other trials in United States

About this study

Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion.

Objectives

Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome)
Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate
Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome)
Evaluate ICU outcomes in each group

Read the detailed description

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.

Objectives
Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome)
Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate
Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome)
Evaluate ICU outcomes in each group:
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
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.
Stopping rule: A statistically significant difference in hospital mortality at 6 months or 12 months
If in favor of LTOWB, consideration of trial termination and making LTOWB the primary standard of care for all trauma patients receiving emergency transfusion except for child-bearing age females (unless Rh immunoglobulin can be administered)
If in favor of component therapy, consideration of trial termination and making component therapy the primary standard care for all trauma patients receiving emergency transfusion

Conditions: Hemorrhagic Shock, Acute Blood Loss Anemia, Traumatic Brain Injury
Being tested: Routine labs
Medical subject headings: Shock, Hemorrhagic, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Routine labsCombination product
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.

Study groups in NCT05081063
Study group	Role	What they receive
Low Titer O+ Whole Blood	Experimental	Low Titer O+ Whole blood provided to Level A trauma patients Receives: Combination Product: Routine labs
Component Therapy	Active comparator	Component Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas Receives: Combination Product: Routine labs

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.

Secondary outcomes (1)

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
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 202215 May 2023

First posted18 Oct 2021
Study start5 Mar 2022
Primary completion15 May 2023
Study completion15 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Hemorrhagic ShockStudies of the same condition, open and under way.
More trials run by Loma Linda UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion
Masking: Single blind
Who is masked: Participant
Enrolment: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05081063
Sponsor's protocol ID: 5210170
Status last verified: Aug 2025
First submitted: 7 Jun 2021
Last updated: 8 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Williams J, Merutka N, Meyer D, Bai Y, Prater S, Cabrera R, Holcomb JB, Wade CE, Love JD, Cotton BA. Safety profile and impact of low-titer group O whole blood for emergency use in trauma. J Trauma Acute Care Surg. 2020 Jan;88(1):87-93. doi: 10.1097/TA.0000000000002498.
PubMed 31464874
Murphy C, Silva de Leonardi N. The use of low-titer group O whole blood is independently associated with improved survival compared to component therapy in adults with severe traumatic hemorrhage. Transfusion. 2021 Apr;61(4):1341-1342. doi: 10.1111/trf.16266. No abstract available.
PubMed 33831229
Seheult JN, Anto V, Alarcon LH, Sperry JL, Triulzi DJ, Yazer MH. Clinical outcomes among low-titer group O whole blood recipients compared to recipients of conventional components in civilian trauma resuscitation. Transfusion. 2018 Aug;58(8):1838-1845. doi: 10.1111/trf.14779. Epub 2018 Aug 30.
PubMed 30160310
Hanna K, Bible L, Chehab M, Asmar S, Douglas M, Ditillo M, Castanon L, Tang A, Joseph B. Nationwide analysis of whole blood hemostatic resuscitation in civilian trauma. J Trauma Acute Care Surg. 2020 Aug;89(2):329-335. doi: 10.1097/TA.0000000000002753.
PubMed 32744830
Cotton BA, Podbielski J, Camp E, Welch T, del Junco D, Bai Y, Hobbs R, Scroggins J, Hartwell B, Kozar RA, Wade CE, Holcomb JB; Early Whole Blood Investigators. A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions. Ann Surg. 2013 Oct;258(4):527-32; discussion 532-3. doi: 10.1097/SLA.0b013e3182a4ffa0.
PubMed 23979267
Strada AM, Suarez G, Luo-Owen X, Tabrizi MB, Rosenthal MG, Stevens WT, Lum SS, Mukherjee K. Pragmatic O-Positive Whole-blood RandoMizaTion in male trauma Patients (POWeR-MTP). Eur J Trauma Emerg Surg. 2025 Apr 16;51(1):175. doi: 10.1007/s00068-025-02848-0.
PubMed 40237834

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hemorrhagic Shock trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients
ClinicalTrials.gov ID: NCT05081063
Acronym / sponsor ID: 5210170
Conditions: Hemorrhagic Shock, Acute Blood Loss Anemia, Traumatic Brain Injury
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 199 participants (actual)
Lead sponsor: Loma Linda UniversityUniversity, hospital or other
Study start: 5 Mar 2022 (actual)
Primary completion: 15 May 2023 (actual)
Study completion: 15 May 2023 (actual)
First posted: 18 Oct 2021 (actual)
Results: Posted 8 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion.

Objectives

Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome)
Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate
Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome)
Evaluate ICU outcomes in each group

Detailed description

Objectives
Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome)
Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate
Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome)
Evaluate ICU outcomes in each group:
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
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.
Stopping rule: A statistically significant difference in hospital mortality at 6 months or 12 months
If in favor of LTOWB, consideration of trial termination and making LTOWB the primary standard of care for all trauma patients receiving emergency transfusion except for child-bearing age females (unless Rh immunoglobulin can be administered)
If in favor of component therapy, consideration of trial termination and making component therapy the primary standard care for all trauma patients receiving emergency transfusion

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion

Arm	Type	Receives
Low Titer O+ Whole Blood	Experimental	Combination Product: Routine labsLow Titer O+ Whole blood provided to Level A trauma patients
Component Therapy	Active comparator	Combination Product: Routine labsComponent Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

all adult male patients brought into the emergency department as LEVEL A trauma activations who are receiving emergency blood transfusions

Key exclusion criteria (4 listed)

Female patients (specifically excluded due to risk of alloimmunization of Rh-negative female patients of childbearing age against Rh-positive blood)
children
prisoners
all patients classified as dead upon arrival to the trauma bay

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Routine labsRoutine 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.	Combination product	Component Therapy, Low Titer O+ Whole Blood

Primary outcome

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)
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.
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.

1 secondary outcome

Mortality
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.

Results and safety

Results posted to the registry on 8 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Titer O+ Whole Blood	52	52
Component Therapy	147	147

Primary outcome: 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)

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.. Mean (Standard Deviation). Unit: units

Measure	Low Titer O+ Whole Blood n = 40	Component Therapy n = 123
Value	3.8 (5.6)	5.7 (6.2)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected through hospital discharge, meaning the duration of time in the hospital after the injury up to 30 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Titer O+ Whole Blood	0 of 52 (0%)	0 of 52 (0%)	17 of 52
Component Therapy	0 of 147 (0%)	0 of 147 (0%)	37 of 147

Limitations and caveats (from the sponsor): Sample size Difference between size of groups Pragmatic randomization scheme

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31464874Williams J, Merutka N, Meyer D, Bai Y, Prater S, Cabrera R, Holcomb JB, Wade CE, Love JD, Cotton BA. Safety profile and impact of low-titer group O whole blood for emergency use in trauma. J Trauma Acute Care Surg. 2020 Jan;88(1):87-93. doi: 10.1097/TA.0000000000002498.
Background: PubMed 33831229Murphy C, Silva de Leonardi N. The use of low-titer group O whole blood is independently associated with improved survival compared to component therapy in adults with severe traumatic hemorrhage. Transfusion. 2021 Apr;61(4):1341-1342. doi: 10.1111/trf.16266. No abstract available.
Background: PubMed 30160310Seheult JN, Anto V, Alarcon LH, Sperry JL, Triulzi DJ, Yazer MH. Clinical outcomes among low-titer group O whole blood recipients compared to recipients of conventional components in civilian trauma resuscitation. Transfusion. 2018 Aug;58(8):1838-1845. doi: 10.1111/trf.14779. Epub 2018 Aug 30.
Background: PubMed 32744830Hanna K, Bible L, Chehab M, Asmar S, Douglas M, Ditillo M, Castanon L, Tang A, Joseph B. Nationwide analysis of whole blood hemostatic resuscitation in civilian trauma. J Trauma Acute Care Surg. 2020 Aug;89(2):329-335. doi: 10.1097/TA.0000000000002753.
Background: PubMed 23979267Cotton BA, Podbielski J, Camp E, Welch T, del Junco D, Bai Y, Hobbs R, Scroggins J, Hartwell B, Kozar RA, Wade CE, Holcomb JB; Early Whole Blood Investigators. A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions. Ann Surg. 2013 Oct;258(4):527-32; discussion 532-3. doi: 10.1097/SLA.0b013e3182a4ffa0.
Derived from this study: PubMed 40237834Strada AM, Suarez G, Luo-Owen X, Tabrizi MB, Rosenthal MG, Stevens WT, Lum SS, Mukherjee K. Pragmatic O-Positive Whole-blood RandoMizaTion in male trauma Patients (POWeR-MTP). Eur J Trauma Emerg Surg. 2025 Apr 16;51(1):175. doi: 10.1007/s00068-025-02848-0.
Individual participant dataSharing planned: No

Related trials for Hemorrhagic Shock

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RecruitingPhase 4
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Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Routine labs in people with Hemorrhagic Shock and Acute Blood Loss Anemia, run by Loma Linda University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05081063, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.