NCT05634109 Whole Blood in Trauma Patients With Hemorrhagic Shock
| NCT ID | NCT05634109 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fundacion Clinica Valle del Lili |
| Condition | Trauma |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-01-14 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 220 participants in total. It began in 2023-01-14 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Alberto F Garcia, MD MSc
PRINCIPAL INVESTIGATOR
Fundacion Clinica Valle del Lili
Frequently Asked Questions
Who can join the NCT05634109 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05634109 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 220 participants.
Is NCT05634109 currently recruiting?
Yes, NCT05634109 is actively recruiting participants. Contact the research team at alberto.garcia@fvl.org.co for enrollment information.
Where is the NCT05634109 trial being conducted?
This trial is being conducted at Cali, Colombia.
Who is sponsoring the NCT05634109 clinical trial?
NCT05634109 is sponsored by Fundacion Clinica Valle del Lili. The principal investigator is Alberto F Garcia, MD MSc at Fundacion Clinica Valle del Lili. The trial plans to enroll 220 participants.