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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
332
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.
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.
Oulu University Hospital
Oulu, North Ostrobothnia, Finland
NOT_YET_RECRUITINGKuopio University Hospital
Kuopio, Northern Savonia, Finland
NOT_YET_RECRUITINGTampere University Hospital
Tampere, Pirkanmaa, Finland
NOT_YET_RECRUITINGTurku University Hospital
Turku, Southwest Finland, Finland
NOT_YET_RECRUITINGHelsinki University Hospital
Helsinki, Uusimaa, Finland
RECRUITINGKarolinska University Hospital
Stockholm, Region Stockholm, Sweden
NOT_YET_RECRUITINGRate of composite outcome of vascular events
Rate of the composite outcome that combines thromboembolic events (ischemic stroke, systemic embolism), hemorrhagic events (intracranial hemorrhage, major extracranial bleeding), and vascular death.
Time frame: 90 days
Rate of different components of the primary composite outcome
Separation of the components of the primary composite outcome (thromboembolic, hemorrhagic, vascular death).
Time frame: 90 days
Rate of patients with favorable functional outcome
Assessed using the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death).
Time frame: 90 days
Rate of reoperation
Reoperation for the initially treated chronic subdural hematoma.
Time frame: 90 days
Rate of all-cause mortality
Time frame: 90 days and 12 months
Participants' healthcare use
Number and type of unscheduled emergency radiological examinations, - number of emergency department visits, postoperative total hospitalization days
Time frame: 90 days
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