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Whole Blood in Trauma Patients With Hemorrhagic Shock

NCT05634109 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-02-27

No results posted yet for this study

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

Interventions

BIOLOGICAL

Transfusion of blood products

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.

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • Hospital Universitario del Valle Evaristo Garcia

    collaborator UNKNOWN

  • Fundacion Clinica Valle del Lili

    lead OTHER

Principal Investigators

  • Alberto F Garcia, MD MSc · Fundacion Clinica Valle del Lili

  • Carlos A Ordoñez, MD · Fundacion Clinica Valle del Lili

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-14
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05634109 on ClinicalTrials.gov