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โ† Trials
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Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation

RecruitingNAAges 18 Years - anyAllRahul Raj
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In plain words

What the trial is, and whether it could suit you

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 follow

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 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)
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What it tests

  • Early Resumption of Oral Anticoagulation Therapy
  • Late Resumption of Oral Anticoagulation Therapy
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Where

6 sites
Oulu University Hospital
Oulu, Finland
Kuopio University Hospital
Kuopio, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Helsinki University Hospital
Helsinki, Finland
Karolinska University Hospital
Stockholm, Sweden
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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