RecruitingNot ApplicableNCT06696079

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

Sponsor

Rahul Raj

Enrollment

332 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)Chronic Subdural Hematoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing the outcomes of restarting blood-thinning medication (anticoagulation) early versus later after brain surgery for a chronic subdural hematoma — a collection of blood on the surface of the brain — in patients who need anticoagulants for atrial fibrillation (an irregular heart rhythm). The goal is to find the safest timing that prevents both re-bleeding and stroke. **You may be eligible if...** - You are 18 or older - You have had a symptomatic chronic subdural hematoma (a slow bleed on the brain surface) that was surgically drained via burr-hole surgery - You take blood thinners due to atrial fibrillation (permanent, persistent, or paroxysmal) - You are enrolled within 4 days of surgery **You may NOT be eligible if...** - You had a bleeding complication during or immediately after surgery - Your hematoma required a more extensive operation (like a full craniotomy) - You had a previous brain blood collection surgery within the past 12 months - You have a cerebrospinal fluid shunt or another reason requiring anticoagulation (like a blood clot or mechanical heart valve) - You have a contraindication to blood thinners (such as a bleeding disorder or severe anemia) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEarly 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.

DRUGLate 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.