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

Rahul Raj

Status: Not yet enrolling

Conditions: Atrial Fibrillation (AF); Chronic Subdural Hematoma

Treatments: Drug: Late Resumption of Oral Anticoagulation Therapy; Drug: Early Resumption of Oral Anticoagulation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06696079

HUS/7351/2024

Details and patient eligibility

About

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.

Enrollment: 332 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 require anticoagulation, including therapeutical dose of low molecular-weight heparin or heparin (for example, pulmonary embolism, deep vein thrombosis, hypercoagulability syndromes)
• Mechanical heart valve(s)
• Moderate or severe mitral stenosis (other valvular diseases and biological valves are eligible)
• Contraindication to anticoagulation medication (for example bleeding disorder, documented high risk of fall [e.g. due to severe alcoholism], severe thrombocytopenia, severe anemia)
• Concomitant use of antiplatelet medication
• Moderate to severe renal insufficiency (creatinine clearance <30 ml/min or on dialysis)
• Not a permanent resident in Finland (for Finnish patients) or not a permanent resident in Region Stockholm (for Swedish patients)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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332 participants in 2 patient groups

Early resumption

Experimental group

Description:

Oral anticoagulation therapy is resumed on the 5th postoperative day following burr-hole surgery for chronic subdural hematoma.

Treatment:

Drug: Early Resumption of Oral Anticoagulation Therapy

Late resumption

Active Comparator group

Description:

Oral anticoagulation therapy is resumed on the 30th postoperative day following burr-hole surgery for chronic subdural hematoma.

Treatment:

Drug: Late Resumption of Oral Anticoagulation Therapy