Whole Blood in Trauma Patients With Hemorrhagic Shock
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacion Clinica Valle del Lili
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Transfusion of blood products
Treatment groups
220 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fundacion Clinica Valle del Lili
Lead sponsor
University of Pittsburgh
Collaborator
Hospital Universitario del Valle Evaristo Garcia
Collaborator
Source ClinicalTrials.gov