NCT06696079

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

Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation (RELACS): An International Multicenter, Randomized Controlled, Two-arm, Assessor-blinded, Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 332 (estimated)
• Sponsor: Rahul Raj · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	Early Resumption of Oral Anticoagulation Therapy	The patient's prescribed anticoagulant therapy for atrial fibrillation is resumed on the 5th postoperative day following burr-hole surgery for chronic subdural hematoma. This early resumption strategy is compared to the standard practice of resuming anticoagulation therapy on the 30th postoperative day.
DRUG	Late Resumption of Oral Anticoagulation Therapy	The patient's prescribed anticoagulant therapy for atrial fibrillation is resumed on the 30th postoperative day following burr-hole surgery for chronic subdural hematoma. This standard resumption strategy is compared to the early approach of resuming anticoagulation therapy on the 5th postoperative day.

Timeline

• Start date: 2025-07-07
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2024-11-19
• Last updated: 2025-08-22

Locations

6 sites across 2 countries: Finland, Sweden