The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma (TRACE)

Inclusion Criteria: Patients aged 45 and older weighing between 45-150 kg diagnosed with symptomatic SDH will be included. SDH is defined as unilateral or bilateral crescentic collection of blood (hyper, iso, or hypodense, or mixed density) of greater than or equals to 8 mm in thickness along the cerebral convexity on CT of the head. Symptomatic SDH patients eligible for inclusion are those with SDH with one or more of the following symptoms attributable to the SDH: headache, gait disturbance, confusion or cognitive decline, limb weakness or numbness/paresthesia, speech or visual disturbance, drowsiness or impaired consciousness, seizures, impaired cognition, or memory loss at the time of assessment. Exclusion Criteria: - Patients will be excluded for any of the following conditions: Asymptomatic for longer than 72 hours SDH less than 8 mm in maximal thickness Have an acutely deteriorating neurological status (e.g., brain herniation with pupillary dilation, aneurysm rupture, etc.) that is likely to be fatal within 6 hours or less due to a predominantly acute SDH Presence of brain contusion larger than 5 cm or subarachnoid hemorrhage (SAH) thicker than 10 mm with Glasgow Coma Scale (GCS)< 13 Patients with primarily interhemispheric or tentorial SDH Hypersensitivity to TXA or any of the placebo ingredients Pregnancy Irregular menstrual bleeding with unidentified cause Known acquired colour vision disturbances Hematuria caused by renal parenchymal disease Acute and chronic renal insufficiency indicated by estimated Glomerular Filtration Rate (eGFR) ≤ 30 mL/min Concomitant (current) intake of birth control pill and/or hormonal replacement therapy, and anti-inhibitor coagulant concentrates (factor VIII inhibitor bypass activity (FEIBA), factor VII, activated factor IX) Consumption coagulopathy/disseminated intravascular coagulation (DIC) in the last 7 days Not competent to take study medication properly and regularly or not having access to caregiver that is able to comply with study medication administration Mechanical heart valve Contraindication to stopping full therapeutic doses of non-acetylsalicylic acid antiplatelets, warfarin, direct oral anticoagulant (e.g., apixaban) or other anticoagulant for 2 weeks after surgery or recent blood clot and/or recent thromboembolic complications in the last 2 weeks SDH caused by intracranial hypotension Known thrombophilia (e.g., antiphospholipid syndrome) Any active malignancy: metastatic cancer systemically or to the brain or a primary malignant brain tumour treated within the last 6 months Previous enrolment in this trial for a prior episode Time interval >3 days from the time of clinical assessment to eligibility assessment Patients weighing <45 kg or >150 kg