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Recruiting NCT05634109

Whole Blood in Trauma Patients With Hemorrhagic Shock

Conditions: Trauma, Trauma Injury, Trauma, Multiple

Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 220
Sponsor: Fundacion Clinica Valle del Lili

Location: Colombia

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 therapyExclusion Criteria:More than 4 hours from trauma to hospital admissionMore than 2 hours from hospital admission to randomizationTransfusion 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 factorSevere 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05634109). StuddyBuddy aggregates publicly available trial information.