Apixaban for Chronic subdural hematoma|Atrial fibrillation

Inclusion criteria

• {"criterion_text":"- Age ≥18 years\n- Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation\n- Patients that are on an oral anticoagulation medication due to permanent, persistent or paroxysmal spontaneous atrial fibrillation previously known\n- Randomization done within 4 days of the surgery\n- Patients with cognitive impairment, including mild cognitive impairment or dementia, are eligible if a legally authorized representative can provide informed consent on their behalf, as detailed in the informed consent section\n- Patients on standard or reduced doses of oral anticoagulants for stroke prevention in atrial fibrillation are eligible. Reduced doses must be in accordance with approved dosing recommendations and clinical practice guidelines based on patient-specific factors such as renal function, age, and body weight."}

Exclusion criteria

• {"criterion_text":"- Intraoperative or immediate postoperative haemorrhagic complication\n- If the operated hematoma reveals to be a cerebrospinal fluid collection (hygroma)\n- 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)\n- Mechanical heart valve(s)\n- Moderate or severe mitral stenosis (other valvular diseases and biological valves are eligible)\n- Women of childbearing potential\n- Contraindication to anticoagulation medication (for example bleeding disorder, documented high risk of fall [e.g. due to severe alcoholism], severe thrombocytopenia, severe anemia)\n- Concomitant use of antiplatelet medication\n- Moderate to severe renal insufficiency (creatinine clearance <30 ml/min or on dialysis)\n- Not a permanent resident in Finland (for Finnish patients) or not a permanent resident in Region Stockholm (Swedish patients)\n- CSDH requiring surgical treatment other than burr-hole evacuation (e.g. craniotomy)\n- Prior CSDH surgery within 12 months\n- Cerebrospinal fluid shunt\n- CSDH is in an arachnoid cyst"}

Primary endpoints

• {"endpoint_text":"- Thromboembolic events (ischemic stroke, systemic embolism)","definition_or_measurement_approach":"Part of the composite primary outcome estimated within 90 days following surgery (composite includes thromboembolic events, haemorrhagic events and vascular death). Thromboembolic events specified as ischemic stroke and systemic embolism."}
• {"endpoint_text":"- Hemorrhagic events","definition_or_measurement_approach":"Part of the composite primary outcome estimated within 90 days following surgery (composite includes thromboembolic events, haemorrhagic events and vascular death). Haemorrhagic events include intracranial haemorrhage and major extracranial bleeding as described in main objective."}
• {"endpoint_text":"- Vascular death","definition_or_measurement_approach":"Part of the composite primary outcome estimated within 90 days following surgery (composite includes thromboembolic events, haemorrhagic events and vascular death). Measured as vascular death within 90 days after surgery."}

Secondary endpoints

• {"endpoint_text":"- All-cause mortality","definition_or_measurement_approach":""}
• {"endpoint_text":"- modified Rankin Scale","definition_or_measurement_approach":""}
• {"endpoint_text":"- Reoperation of ipsilateral hematoma","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number and type of unscheduled emergency radiological examinations","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of emergency department visits","definition_or_measurement_approach":""}
• {"endpoint_text":"- Postoperative total hospitalization days, counted from the day of surgery","definition_or_measurement_approach":"Counted from the day of surgery (explicitly stated)."}
• {"endpoint_text":"- Separation of the components of the primary outcome","definition_or_measurement_approach":"Analysis/separation of the individual components of the composite primary outcome (thromboembolic events, haemorrhagic events, vascular death)."}

Finland

Earliest CTIS Part Ii Submission Date

07-05-2025

Latest Decision Or Authorization Date

04-06-2025

Processing Time Days

28

Number Of Sites

5

Number Of Participants

242

Sweden

Earliest CTIS Part Ii Submission Date

07-05-2025

Latest Decision Or Authorization Date

05-06-2025

Processing Time Days

29

Number Of Sites

1

Number Of Participants

90

Primary sponsor

Full Name

HUS-Yhtymae

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland