Phase
Condition
Stroke
Chest Pain
Cardiac Disease
Treatment
Late Resumption of Oral Anticoagulation Therapy
Early Resumption of Oral Anticoagulation Therapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years.
Patients with a symptomatic unilateral or bilateral CSDH requiring burr-holeevacuation with drainage (CSDH is predominantly hypodense or isodense on imaging [CT/MRI]; clinical symptoms attributable to the CSDH; patients with bilaterallyoperated CSDHs will be treated with the same protocol on both sides and analyzed asa single study participant).
Patients that are on an oral anticoagulation medication due to permanent, persistentor paroxysmal spontaneous atrial fibrillation previously known
Randomization done within 4 days of the surgery
Exclusion
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, includingtherapeutical 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 valvesare eligible)
Contraindication to anticoagulation medication (for example bleeding disorder,documented high risk of fall [e.g. due to severe alcoholism], severethrombocytopenia, severe anemia)
Concomitant use of antiplatelet medication
Moderate to severe renal insufficiency (creatinine clearance <30 ml/min or ondialysis)
Not a permanent resident in Finland (for Finnish patients) or not a permanentresident in Region Stockholm (for Swedish patients)
Study Design
Connect with a study center
Oulu University Hospital
Oulu 643492, North Ostrobothnia 830667 90220
FinlandSite Not Available
Kuopio University Hospital
Kuopio 650224, Northern Savonia 830690 70200
FinlandSite Not Available
Tampere University Hospital
Tampere, Pirkanmaa 33520
FinlandSite Not Available
Tampere University Hospital
Tampere 634963, Pirkanmaa 830704 33520
FinlandSite Not Available
Oulu University Hospital
Oulu, Pohjois-Pohjanmaa 90220
FinlandSite Not Available
Kuopio University Hospital
Kuopio, Pohjois-Savo 70200
FinlandSite Not Available
Turku University Hospital
Turku 633679, Southwest Finland 830708 20520
FinlandSite Not Available
Helsinki University Hospital
Helsinki, Uusimaa 00260
FinlandSite Not Available
Helsinki University Hospital
Helsinki 658225, Uusimaa 830709 00260
FinlandActive - Recruiting
Turku University Hospital
Turku, Varsinais-Suomi 20520
FinlandSite Not Available
Karolinska University Hospital
Stockholm, Region Stockholm 17164
SwedenSite Not Available
Karolinska University Hospital
Stockholm 2673730, Region Stockholm 17164
SwedenSite Not Available

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