This study is an open label randomized controlled trial. Patients with a symptomatic Chronic Subdural Hematoma (CSDH) confirmed on radiological imaging, planned for surgery, age over 18, free from other intracranial pathologies and no previous intracranial surgery, will be recruited at time of admission. Patients eligible for inclusion will be randomized to receive treatment with Tranexamic acid (TXA) as an adjunct to surgery or surgery alone. Surgical evacuation will be performed using a single or double burr hole and 24 hours postoperative drainage. The primary endpoint will be recurrent hematoma requiring repeat surgery within 90 days. Secondary outcomes will be modified Rankin Scale at 90 days, EQ-5D-5L, complications and adverse events, and 90-day mortality.
Symptomatic chronic subdural hematoma confirmed on computer tomography (CT) or magnetic resonance imaging (MRI) measuring greater than 10 mm thickness.
Adult patient ≥18 years
Scheduled for single or double burr hole for evacuation.
No contraindication for TXA
Mechanical heart valve
Newly diagnosed (last 12 months) pulmonary embolism, myocardial infarction, and strong indication for antithrombotic treatment
Intracranial surgery within last 6 months
Pregnancy and woman<40 years
Parallel
Tranexamic Acid (Cyklokapron)
DrugPatients randomized to the treatment group will receive 1g of TXA pre and postoperative intravenously administrated followed by a 28 days treatment course of 500mg x2 of TXA orally
Recurrence of symptomatic chronic subdural hematoma requiring repeat surgery within 90 days
Number of patients with a radiological and clinical significant recurrent hematoma withing 90 days
Functional outcome
Functional outcome measured with the modified Rankin Scale (mRS) score, range 0 (no symptoms) to 6 (death)
Health-related Quality Of Life
Change from baseline in generic health-related quality of life measured with the five dimensional EuroQol questionnaire (EQ-5D-L)
Headache
Change in headache intensity measured with numerical rating scale (1-10)
Complications and adverse events
Complications and adverse events
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St. Olavs Hospital
Lead sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Collaborator
