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
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Kuopio University Hospital
NOT_YET_RECRUITING
Kuopio
Oulu University Hospital
NOT_YET_RECRUITING
Oulu
Tampere University Hospital
NOT_YET_RECRUITING
Tampere
Turku University Hospital
NOT_YET_RECRUITING
Turku
Sweden
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
Contact Information
Primary
Rahul Raj, MD, PhD
rahul.raj@hus.fi
+358504272516
Backup
Jarno Satopää, MD, PhD
jarno.satopaa@hus.fi
+358504286743‬
Time Frame
Start Date: 2025-07-07
Estimated Completion Date: 2027-06
Participants
Target number of participants: 332
Treatments
Experimental: Early resumption
Oral anticoagulation therapy is resumed on the 5th postoperative day following burr-hole surgery for chronic subdural hematoma.
Active_comparator: Late resumption
Oral anticoagulation therapy is resumed on the 30th postoperative day following burr-hole surgery for chronic subdural hematoma.
Sponsors
Collaborators: Oulu University Hospital, Tampere University Hospital, Karolinska University Hospital, Turku University Hospital, Kuopio University Hospital
Leads: Rahul Raj

This content was sourced from clinicaltrials.gov

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