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RECRUITING
NCT06696079
NA

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

Sponsor: Rahul Raj

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

332

Start Date

2025-07-07

Completion Date

2027-06

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

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.

Locations (6)

Oulu University Hospital

Oulu, North Ostrobothnia, Finland

Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Turku University Hospital

Turku, Southwest Finland, Finland

Helsinki University Hospital

Helsinki, Uusimaa, Finland

Karolinska University Hospital

Stockholm, Region Stockholm, Sweden