Actively Recruiting
Whole Blood in Trauma Patients With Hemorrhagic Shock
Led by Fundacion Clinica Valle del Lili · Updated on 2025-02-27
220
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
Sponsors
F
Fundacion Clinica Valle del Lili
Lead Sponsor
U
University of Pittsburgh
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Whole Blood in Trauma Patients With Hemorrhagic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (over 18 years old)
- Trauma patients with hemorrhagic shock activating institutional trauma code
- Candidates for massive transfusion (Assessment Blood Consumption Score of 2 or higher or physician discretion)
- Availability of whole blood or blood component therapy at the time of treatment
You will not qualify if you...
- More than 4 hours between trauma and hospital admission
- More than 2 hours from hospital admission to randomization
- Transfusion of more than one packed red blood cell unit before randomization
- Surgery (laparotomy, thoracotomy, or sternotomy) performed before hospital admission
- Patients expected to die within 60 minutes due to severe injuries
- Blood group other than O or A with positive Rh factor
- Severe traumatic brain injury where neurosurgical intervention is not possible
- Burns covering more than 20% of total body surface area
- Suspected airway burns
- Cardiopulmonary resuscitation before emergency department arrival
- Cardiopulmonary resuscitation lasting more than 5 minutes before randomization
- Do not resuscitate orders
- Incarcerated or prisoner status
- Known pregnancy at emergency department admission
- Refusal to participate in clinical research by patient or legal representative
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fundacion Clinica Valle del Lili
Cali, Valle del Cauca Department, Colombia
Actively Recruiting
Research Team
A
Alberto F Garcia, MD MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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