Whole Blood in Trauma Patients With Hemorrhagic Shock

NCT05634109 | Recruiting Phase 3 DMC

• 1 other identifier: 1938
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate among trauma patients with hemorrhagic shock the clinical impact of hemostatic resuscitation between whole blood vs. blood components therapy in the following outcomes in a hierarchical analysis: mortality at 28 days and evolution of organ dysfunction.

Conditions

Trauma; Trauma Injury; Trauma, Multiple

Keywords

whole blood; Blood Transfusion; Blood Component Transfusion; Hemorrhage; Advanced Trauma Life Support Care; Hemostatic resuscitation

Outcome Measures

Primary Outcomes (1)

• The primary outcome is a hierarchical outcome consisting of mortality at 28 days post-randomization and evolution of organ dysfunction (difference of Sequential Organ Failure Assessment (SOFA) score between day 1 and day 5 post-randomization).

  The primary outcome is a hierarchical composite outcome that will be analyzed using the Win-Ratio test. The first level will be 28-day mortality. The "winner" will be the participant who survival; in case of a tie, the second level will be the difference in SOFA score between fifth and first day. The "winner" will be participant with the lowest difference.

  28 days post ED admission

Secondary Outcomes (9)

• 24-hour mortality

  First 24 hours post ED admission.

• In-hospital mortality

  28 days post ED admission

• Multiple organ dysfunction incidence

  1-day / 3-day / 5-day / 7-day post-ED admission

• Evolution of Coagulopathy

  Admission - 3 hours - 6 hours - 24 hours post-ED admission

• Intensive care unit-free days

  28-days post-ED admission

Study Arms (2)

Whole Blood

EXPERIMENTAL

Leukoreduced whole blood with a platelet-sparing filter. Participants will be transfused with 3 whole blood units. If the participant requires, an additional transfusion pack composite by 3 whole blood units will be administered.

Biological: Transfusion of blood products

Blood Components Therapy

ACTIVE COMPARATOR

1:1:1 ratio of red blood cells unit, plasma unit, and platelets unit. Participants will be transfused with 3 red blood cell units, 3 fresh frozen plasma units, and 3 platelets units. A second intervention with the same ratio can be transfused to participants if they require it.

Biological: Transfusion of blood products

Interventions

Transfusion of blood products BIOLOGICAL

The intervention will be either a) administration of 6 units of whole blood or b) administration of blood component therapy in the proportion of 6:6:6 units of red blood cells, plasma, and platelets.

Blood Components Therapy; Whole Blood

Eligibility Criteria

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

You may qualify if:

• Adult patients (\> 18 years)
• Activating institutional trauma code for trauma patients with hemorrhagic shock.
• Candidate for massive transfusion (Patient with an Assessment Blood Consumption (ABC) Score ≥ 2 or at the discretion of the treating physician)
• Concurrent availability of whole blood or blood component therapy

You may not qualify if:

• More than 4 hours from trauma to hospital admission
• More than 2 hours from hospital admission to randomization
• Transfusion of more than one packed red blood cell unit prior to randomization.
• Patients who have undergone surgery (laparotomy, thoracotomy, or sternotomy) before hospital admission.
• In-extremis patients with devastating injuries (expected to die within 60 minutes).
• Blood group other than to O or A and positive Rh factor
• Severe traumatic brain injury in which neurosurgical intervention is futile (partial decapitation, massive intracranial hemorrhage, or transcranial gunshot wounds).
• Burns over 20% of the total body surface area.
• Suspected airway burn.
• Cardiopulmonary resuscitation (CPR) before arrival at the ED.
• CPR for more than 5 minutes before randomization.
• Do not resuscitate order.
• Incarcerated/prisoners.
• Known pregnancy in the ED.
• Patient or legal representative who refuse to participate in clinical research studies.

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead
• University of Pittsburgh: collaborator
• Hospital Universitario del Valle Evaristo Garcia: collaborator

Study Sites (1)

Fundacion Clinica Valle del Lili

Cali, Valle del Cauca Department, Colombia

RECRUITING

Related Publications (1)

• Garcia AF, Caicedo Y, Gempeler A, Vallecilla L, Macia C, Orlas C, Fernandez MI, Lancheros-Ramirez P, Quintero M, Hernandez E, Vargas S, Cardenas-Perez L, Ariza F, Zarama V, Carvajal S, Billefals E, Sanchez A, Badiel M, Rosso F, Granados M, Albornoz LA, Puyana JC, Ospina-Tascon G, Ordonez CA. Transfusion of modified whole blood versus blood components therapy in patients with severe trauma: Randomized controlled trial protocol (WEBSTER trial). Injury. 2025 May;56(5):112173. doi: 10.1016/j.injury.2025.112173. Epub 2025 Jan 23.

  PMID: 40087111 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Accidental Injuries; Multiple Trauma; Hemorrhage

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Alberto F Garcia, MD MSc

  Fundacion Clinica Valle del Lili

  PRINCIPAL INVESTIGATOR

• Carlos A Ordoñez, MD

  Fundacion Clinica Valle del Lili

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto F Garcia, MD MSc

CONTACT

+576023319090; alberto.garcia@fvl.org.co

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, Controlled, Randomized, and Open label therapeutic trial.

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 1, 2022
• Study Start: January 14, 2023
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

CO (1)