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 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT05472766
Eligibility Criteria:
Inclusion Criteria:
1. ≥18 years of age
2. Any SDH, defined as either acute or encapsulated partially liquefied hematoma in the subdural space diagnosed on a CT scan
3. Can have surgical drainage (either burr hole or craniotomy) for aSDH and cSDH
4. On therapeutic anticoagulation (DOAC or warfarin) as standard of care therapy prior to presentation for stroke prophylaxis secondary to AF
Exclusion Criteria:
1. aSDH requiring decompressive craniectomy
2. Mechanical heart valve or moderate to severe mitral stenosis
3. Known chronic coagulopathy (elevated INR \>1.5 or PTT\>40s after anticoagulant reversal, thrombocytopenia with platelet count \<50x109/L) that is not amenable to reversal
4. \>37 days has elapsed since initial diagnosis without recruitment into the trial
5. Active gastroduodenal ulcer, urogenital or respiratory tract hemorrhage
6. Known pregnancy or breastfeeding
7. Indication for therapeutic anticoagulation other than AF
8. Pre-randomization brain CT at 2-4 weeks after initial diagnosis or surgery date reveals significant recurrence requiring surgical drainage
9. Known to be non-compliant with prior anticoagulant
10. MRP decides to restart Warfarin (as opposed to DOACs) as prophylactic anticoagulant as part of standard therapy for the patient after cSDH or aSDH
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05472766
Study Brief:
Protocol Section:
NCT05472766