Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT03780894
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03780894
Study Brief:
Protocol Section:
NCT03780894