← Back to Clinical Trials
Recruiting NCT06696079

Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation

Trial Parameters

Condition Chronic Subdural Hematoma
Sponsor Rahul Raj
Study Type INTERVENTIONAL
Phase N/A
Enrollment 332
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-07-07
Completion 2026-12
Interventions
Early Resumption of Oral Anticoagulation TherapyLate Resumption of Oral Anticoagulation Therapy

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.

Eligibility Criteria

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 months * Cerebrospinal fluid shunt * CSDH is in an arachnoid cyst * If the operated hematoma is revealed to be a cerebrospinal fluid collection (hygroma) * Conditions other than atrial fibrillation that

Related Trials