Using whole blood for trauma patients with severe bleeding
Whole Blood vs. Blood Components Therapy in the Hemostatic Resuscitation of Severe Trauma Patients: An Open-label, Randomized, Controlled Clinical Trial
This study tests whether using whole blood for trauma patients with severe bleeding can help them survive better and have fewer organ problems compared to traditional blood treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacion Clinica Valle del Lili Academic / other |
| Locations | 1 site (Cali, Valle del Cauca Department) |
| Trial ID | NCT05634109 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical impact of hemostatic resuscitation using whole blood compared to traditional blood component therapy in trauma patients experiencing hemorrhagic shock. It aims to determine the effects on mortality rates and organ dysfunction over a 28-day period. The trial will be conducted as an open-label, randomized, prospective, single-center study, enrolling adult patients who require a blood transfusion due to severe trauma. The research seeks to clarify the benefits of whole blood transfusion in emergency settings, particularly in low-resource environments.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have experienced severe trauma and are in need of a massive blood transfusion.
Not a fit: Patients who have sustained devastating injuries or have specific contraindications, such as severe traumatic brain injury or burns over 20%, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality and improve recovery outcomes for trauma patients with severe bleeding.
How similar studies have performed: While the use of whole blood in trauma settings is gaining attention, this specific approach is still being evaluated and has not been widely tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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 availability of whole blood or blood component therapy Exclusion Criteria: * 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. * In-extremis patients with devastating injuries (expected to die within 60 minutes). * Blood group other than to O or A and positive Rh factor * Severe traumatic brain injury in which neurosurgical intervention is futile (partial decapitation, massive intracranial hemorrhage, or transcranial gunshot wounds). * Burns over 20% of the total body surface area. * Suspected airway burn. * Cardiopulmonary resuscitation (CPR) before arrival at the ED. * CPR for more than 5 minutes before randomization. * Do not resuscitate order. * Incarcerated/prisoners. * Known pregnancy in the ED. * Patient or legal representative who refuse to participate in clinical research studies.
Where this trial is running
Cali, Valle del Cauca Department
- Fundacion Clinica Valle del Lili — Cali, Valle del Cauca Department, Colombia (Recruiting)
Study contacts
- Principal investigator: Alberto F Garcia, MD MSc — Fundacion Clinica Valle del Lili
- Study coordinator: Alberto F Garcia, MD MSc
- Email: alberto.garcia@fvl.org.co
- Phone: +576023319090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.