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

Not Applicable

Not yet recruiting

• Conditions: Chronic Subdural Hematoma; Atrial Fibrillation (AF)
• Interventions: Drug: Early Resumption of Oral Anticoagulation Therapy; Drug: Late Resumption of Oral Anticoagulation Therapy

• Registration Number: NCT06696079
• Lead Sponsor: Rahul Raj

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-19
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Study Start: 2025-02
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 332

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early resumption	Early Resumption of Oral Anticoagulation Therapy	Oral anticoagulation therapy is resumed on the 5th postoperative day following burr-hole surgery for chronic subdural hematoma.
Late resumption	Late Resumption of Oral Anticoagulation Therapy	Oral anticoagulation therapy is resumed on the 30th postoperative day following burr-hole surgery for chronic subdural hematoma.

Primary Outcome Measures

Name	Time	Method
Rate of composite outcome of vascular events	90 days	Rate of the composite outcome that combines thromboembolic events (ischemic stroke, systemic embolism), hemorrhagic events (intracranial hemorrhage, major extracranial bleeding), and vascular death.

Secondary Outcome Measures

Name	Time	Method
Rate of different components of the primary composite outcome	90 days	Separation of the components of the primary composite outcome (thromboembolic, hemorrhagic, vascular death).
Rate of patients with favorable functional outcome	90 days	Assessed using the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death).
Rate of reoperation	90 days	Reoperation for the initially treated chronic subdural hematoma.
Rate of all-cause mortality	90 days and 12 months
Participants' healthcare use	90 days	Number and type of unscheduled emergency radiological examinations, - number of emergency department visits, postoperative total hospitalization days

Trial Locations

Locations (6)

Tampere University Hospital; 🇫🇮 Tampere, Pirkanmaa, Finland

Oulu University Hospital; 🇫🇮 Oulu, Pohjois-Pohjanmaa, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Pohjois-Savo, Finland

Helsinki University Hospital; 🇫🇮 Helsinki, Uusimaa, Finland

Turku University Hospital; 🇫🇮 Turku, Varsinais-Suomi, Finland

Karolinska University Hospital; 🇸🇪 Stockholm, Region Stockholm, Sweden