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Recruiting Phase 3 NCT05634109

Whole Blood in Trauma Patients With Hemorrhagic Shock

Trial Parameters

Condition Trauma
Sponsor Fundacion Clinica Valle del Lili
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 220
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-01-14
Completion 2025-12
Interventions
Transfusion of blood products

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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% o

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