Using whole blood for trauma patients with severe bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.