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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Transfusion of blood products
Biological/VaccineThe 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.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Whole BloodExperimental treatment 1 intervention
Group B: Blood Components TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The primary outcome is a hierarchical outcome consisting of mortality at 28 days post-randomization and evolution of organ dysfunction (difference of Sequential Organ Failure Assessment (SOFA) score between day 1 and day 5 post-randomization).
The primary outcome is a hierarchical composite outcome that will be analyzed using the Win-Ratio test. The first level will be 28-day mortality. The "winner" will be the participant who survival; in case of a tie, the second level will be the difference in SOFA score between fifth and first day. The "winner" will be participant with the lowest difference.
Time frame
28 days post ED admissionSecondary outcomes
1
24-hour mortality
The occurrence of deaths in the first 24 hours post-ED admission and we will document and record the time of death in hours.
Time frame
First 24 hours post ED admission.2
In-hospital mortality
The occurrence of deaths during the hospital stays post-ED admission, and we will document and record the time of death in days.
Time frame
28 days post ED admission3
Multiple organ dysfunction incidence
Multiple organ dysfunction is a score ≥ 3 in two or more systems evaluated by SOFA score.
Time frame
1-day / 3-day / 5-day / 7-day post-ED admission4
Evolution of Coagulopathy
We will evaluate the values of INR, fibrinogen, and MA-TEG during the admission and the first 24 hours post-ED admission.
Time frame
Admission - 3 hours - 6 hours - 24 hours post-ED admissionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundacion Clinica Valle del Lili
Lead sponsor
University of Pittsburgh
Collaborator
Hospital Universitario del Valle Evaristo Garcia
Collaborator
Source ClinicalTrials.gov