Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemo… (NCT03780894) | Clinical Trial Compass
CompletedPhase 1/2
Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care.
Spain79 participantsStarted 2018-11-21
Plain-language summary
This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This study compares presence of Trauma Induced Coagulopathy (TIC) and acute traumatic hemorrhage treatment at pre-hospital phase of care with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC) with the current treatment based on the administration of Crystalloids and TXA.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years AND
* Patients with severe trauma categorized as priority 0 or 1 according to the CatSalut Polytrauma Code (PPT) AND
* Evidence of bleeding or a high bleeding suspicion according to physician judgment OR
* Predicted to need transfusion according to TICCS score ≥10
Exclusion Criteria:
* Moribund patient with devastating injuries and expected to die within 1-hour OR
* Known objection to blood components transfusion OR
* Known acquired or congenital coagulopathies not related to the actual trauma OR
* Known anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxaban, apixaban) OR
* Known Pregnancy OR
* Severe isolated traumatic brain injury OR
* Hemorrhage not related to the actual trauma
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)
Timeframe: Basal (at the crash site)
2
TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)
Timeframe: Basal (at the hospital arrival)
3
All-cause mortality
Timeframe: 1 hour post hospital admission
4
All-cause mortality
Timeframe: 6 hours post hospital admission
5
All-cause mortality
Timeframe: 24 hours post hospital admission
6
Accountability
Timeframe: 30 days
7
Temperature storage conditions of the red blood cells concentrate