Transfusion of modified whole blood versus blood components therapy in patients with severe trauma: Randomized controlled trial protocol (WEBSTER trial).
Alberto F García, Yaset Caicedo, Andrés Gempeler...
https://pubmed.ncbi.nlm.nih.gov/40087111Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID05634109
Whole Blood vs. Blood Components Therapy in the Hemostatic Resuscitation of Severe Trauma Patients: An Open-label, Randomized, Controlled Clinical Trial
Led by Fundacion Clinica Valle del Lili · Updated on 2025-02-27
220
Participants Needed
1
Research Sites
12 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
Researchers are evaluating hemostatic resuscitation methods in trauma patients experiencing hemorrhagic shock, comparing the use of whole blood against traditional blood components therapy. The study aims to clarify the effects of whole blood resuscitation on outcomes such as mortality within 28 days and changes in organ function. This open-label, randomized, controlled trial addresses ongoing uncertainties about the best approach to blood transfusion in severe trauma care. Participants are randomly assigned to one of two groups: the experimental group receives transfusions of whole blood in packs of three units, with the possibility of a second pack if needed; the control group receives blood components in a 1:1:1 ratio—three units each of red blood cells, fresh frozen plasma, and platelets—with a similar option for additional transfusions. The trial is conducted at a single center and includes prospective enrollment of severe trauma patients requiring transfusion. During the study, participants will be monitored for mortality at 28 days and organ dysfunction measured by changes in the Sequential Organ Failure Assessment (SOFA) score from day one to day five. Secondary outcomes include early and in-hospital mortality, incidence of organ dysfunction over the first week, coagulopathy evolution, intensive care and hospital stay durations, transfusion volumes, and transfusion-related complications. Safety assessments cover transfusion reactions and trauma-related adverse events, ensuring comprehensive follow-up until 28 days post-admission.
CONDITIONS
Brief Title
Whole Blood in Trauma Patients With Hemorrhagic Shock
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients over 18 years old
- Trauma patients with hemorrhagic shock activating institutional trauma code
- Candidate for massive transfusion with an Assessment Blood Consumption (ABC) Score of 2 or higher or as decided by the treating physician
- Concurrent availability of whole blood or blood component therapy
You will not qualify if you...
- 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 before randomization
- Patients who had surgery (laparotomy, thoracotomy, or sternotomy) before hospital admission
- In-extremis patients expected to die within 60 minutes
- Blood group other than O or A with positive Rh factor
- Severe traumatic brain injury where neurosurgery is not possible
- Burns covering more than 20% of total body surface area
- Suspected airway burn
- Cardiopulmonary resuscitation before arrival at the emergency department
- CPR lasting more than 5 minutes before randomization
- Do not resuscitate order
- Incarcerated or prisoners
- Known pregnancy in the emergency department
- Patient or legal representative refusal to participate in clinical research studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Treatment
Duration - Up to 24 hours post emergency department admission
Participants receive transfusions as part of hemostatic resuscitation. They are randomly assigned to receive either whole blood units or blood component therapy. If needed, a second transfusion with the same type and amount may be given.
Initial transfusion and possible second transfusion within 24 hours
Follow-up
Duration - Up to 28 days post emergency department admission
Participants are monitored for outcomes including mortality, organ function, coagulopathy, transfusion reactions, and other safety events up to 28 days after admission.
Multiple assessments during hospital stay and follow-up visits as needed
Trial Site Locations
Total: 1 location
1
Fundacion Clinica Valle del Lili
Cali, Valle del Cauca Department, Colombia
Actively Recruiting
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Research Team
A
Alberto F Garcia, MD MSc
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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