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:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT03320603
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (≥ 18 years old)
* Receiving oral anticoagulants (VKA or DOAC)
* With a severe bleeding episode meeting at least one of the following criteria
* External hemorrhage which cannot be controlled by usual means or
* Hemodynamic instability: SBP \< 90 mmHg or SBP decrease
* 40 mmHg from usual SBP or mean BP \< 65 mmHg or any sign of shock or
* Patient requiring a hemostatic procedure in emergency:
surgery, interventional radiology, endoscopy or
* Need for transfusion of packed red blood cells or
* Hemorrhage jeopardizing the vital or functional prognosis:
e.g. intracranial hemorrhage, intraspinal hemorrhage, intraocular or retro-ocular hemorrhage, hemothorax, hemoperitoneum, retroperitoneal hemorrhage, hemopericardium, deep muscle hematoma or compartment syndrome, acute digestive hemorrhage, hemarthrosis.
* Admitted in the participating emergency service
* Accepting the collection of his/her own health-related data
Exclusion Criteria:
* Patient participating in another interventional study
* Pregnant or nursing woman
* Patient under supervision or legal guardianship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03320603
Study Brief:
Protocol Section:
NCT03320603