Interventional Recruiting
NCT06696079 on ClinicalTrials.gov
Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation
Official title: Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation (RELACS): An International Multicenter, Randomized Controlled, Two-arm, Assessor-blinded, Trial
- Sponsor: Rahul Raj
- Collaborators: Tampere University Hospital, Kuopio University Hospital, Turku University Hospital, Oulu University Hospital, Karolinska University Hospital
- Enrollment: 332 (Estimated)
- Study start: 2025-07-07 (Actual)
- Primary completion: 2026-12-01 (Estimated)
- Study completion: 2027-06-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: Single (Outcomes Assessor)
- PrimaryPurpose: Treatment
Brief Summary
The goal of this randomized clinical trial is to assess the benefit of early resumption versus late resumption of oral anticoagulation medication in adults with atrial fibrillation undergoing surgery for chronic subdural hematoma. The main questions it aims to answer are:
* Does anticoagulation resumption 5 days after surgery as compared to 30 days after surgery result in fewer thromboembolic complications, without increasing the risk for bleeding?
* Does anticoagulation resumption 5 days after surgery as compared to 30 days after surgery affect the risk of reoperation, functional outcome, mortality, and healthcare use?
Researchers will compare early anticoagulation resumption (5 days) and late anticoagulation resumption (30 days) after chronic subdural hematoma surgery.
Participants will either resume the medication 5 days or 30 days after the surgery. The participants will be followed up for 3 months after the surgery.
Conditions
- Chronic Subdural Hematoma
- Atrial Fibrillation (AF)
Intervention / Treatment
- Drug: Early Resumption of Oral Anticoagulation Therapy
- Drug: Late Resumption of Oral Anticoagulation Therapy
Primary Outcome Measures
-
Rate of composite outcome of vascular events
(90 days)
Rate of the composite outcome that combines thromboembolic events (ischemic stroke, systemic embolism), hemorrhagic events (intracranial hemorrhage, major extracranial bleeding), and vascular death.
Countries
Finland, Sweden
Locations and Investigators
-
Karolinska University Hospital, Solna, Sweden
- Jiri, Bartek
-
Oulu University Hospital, Oulu, Finland
- Oula, Knuutinen
-
Kuopio University Hospital, Kuopio, Finland
- Nils, Danner
- Turku University Hospital, Turku, Finland
-
Tampere University Hospital, Tampere, Finland
- Teemu, Luoto
-
HUS-Yhtymae, Helsinki, Finland
- Rahul, Raj
Study Officials
- Rahul Raj, MD, PhD (Study Chair) — Helsinki University Hospital & University of Helsinki
- Jarno Satopää, MD, PhD (Principal Investigator) — Helsinki University Hospital & University of Helsinki
- Jussi P Posti, MD, PhD (Principal Investigator) — Turku University Hospital and University of Turku
- Teemu Luoto, MD, PhD (Principal Investigator) — Tampere University Hospital and Tampere University
- Nils Danner, MD, PhD (Principal Investigator) — Kuopio University Hospital and University of Eastern Finland
- Oula Knuutinen, MD, PhD (Principal Investigator) — Oulu University Hospital and University of Oulu
- Jiri Bartek, MD, PhD (Principal Investigator) — Karolinska University Hospital