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New treatment option for Trauma
Official title Whole Blood in Trauma Patients With Hemorrhagic Shock
ClinicalTrials.gov ID: NCT05634109
What this study is testing
What is Transfusion of blood products?
Transfusion of blood products is an investigational medicine, being studied as a potential treatment for trauma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cali, Valle del Cauca Department, Colombia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cali, Valle del Cauca Department, Colombia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.