Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fi
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
| Condition(s) | Chronic Subdural Hematoma, Atrial Fibrillation (AF) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: * Age ≥18 years. * Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation with drainage (CSDH is predominantly hypodense or isodense on imaging \[CT/MRI\]; clinical symptoms attributable to the CSDH; patients with bilaterally operated CSDHs will be treated with the same protocol on both sides and analyzed as a single study participant). * Patients that are on an oral anticoagulation medication due to permanent, persistent or paroxysmal spontaneous atrial fibrillation previously known * Randomization done within 4 days of the surgery Exclusion Criteria: * Intraoperative or immediate postoperative hemorrhagic complication * CSDH requiring surgical treatment other than burr-hole evacuation (e.g. craniotomy) * Prior CSDH surgery within 12 mo |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Rahul Raj |
| Locations | Oulu, North Ostrobothnia, Finland; Kuopio, Northern Savonia, Finland; Tampere, Pirkanmaa, Finland; Turku, Southwest Finland, Finland; Helsinki, Uusimaa, Finland; Stockholm, Region Stockholm, Sweden |
| Start date | 2025-07-07 |
| NCT ID | NCT06696079 |
| Official listing | https://clinicaltrials.gov/study/NCT06696079 |