Whole Blood in Trauma Patients With Hemorrhagic Shock

Recruiting Phase 3 Interventional Study
Trauma Trauma Injury Trauma, Multiple
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
Fundacion Clinica Valle del Lili · Other
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About This Trial

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.

Trial Locations
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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 availa…
Contacts

Alberto F Garcia, MD MSc

+576023319090

alberto.garcia@fvl.org.co

CONTACT