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

NCT05081063 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 5210170
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Hemorrhagic Shock; Acute Blood Loss Anemia; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

Study Arms (2)

Low Titer O+ Whole Blood

EXPERIMENTAL

Low Titer O+ Whole blood provided to Level A trauma patients

Combination Product: Routine labs

Component Therapy

ACTIVE COMPARATOR

Component Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas

Combination Product: Routine labs

Interventions

Routine labs COMBINATION_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.

Component Therapy; Low Titer O+ Whole Blood

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

Related Publications (6)

• 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.

  PMID: 31464874 BACKGROUND

• 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.

  PMID: 33831229 BACKGROUND

• 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.

  PMID: 30160310 BACKGROUND

• 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.

  PMID: 32744830 BACKGROUND

• 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.

  PMID: 23979267 BACKGROUND

• 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.

  PMID: 40237834 DERIVED

MeSH Terms

Conditions

Shock, Hemorrhagic; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

Sample size Difference between size of groups Pragmatic randomization scheme

Results Point of Contact

• Title: Kaushik Mukherjee
• Organization: Loma Linda University Health

kmukherjee@llu.edu

9096515948

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Surgery, Trauma Division

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

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: October 18, 2021
• Study Start: March 5, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: August 8, 2025
• Results First Posted: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)