Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma (TRACE)
Chronic Subdural Hematoma
About this trial
This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring Chronic subdural hematoma, Tranexamic acid, TXA
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with chronic subdural hematoma, and have a planned or have received a unilateral or bilateral burr-hole craniostomy or mini-craniotomy
- Written informed consent (patient, power of attorney or substitute decision maker)
- Competence to take study medication properly and regularly or access to care giver that is able to comply with accurate study medication administration
Exclusion Criteria:
- Hypersensitivity to TXA or any of the ingredients
- Pregnancy
- Irregular menstrual bleeding with unidentified cause
- Acquired colour vision disturbances
- Acute and chronic renal insufficiency indicated by glomerular filtration rate (GFR) ≤ 30 mL/min
- Hematuria, caused by diseases of renal parenchyma
- Current alcohol abuse (as indicated by an Alcohol Use Disorders Identification Test (AUDIT) score of 10 or higher) drug abuse, or recreational drug use
- Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX)
- Active, history, or increased risk of thrombotic events (including deep vein thrombosis, pulmonary embolism, cerebral venous thrombosis, arterial thrombotic events), symptomatic carotid stenosis, myocardial infarction, acute coronary syndrome, coronary artery disease, or consumption coagulopathy within the past 2 years
- History of angioplasty with cardiac stent placement or mechanical heart valve
- Active or history of brain pathologies such as stroke (hemorrhagic and ischemic), subarachnoid hemorrhage, or malignant brain tumors (glioma, metastasis and others) as well as history of seizures within the past 2 years
- Contraindication to stopping full therapeutic doses of non-acetylsalicylic acid (ASA) antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery
- Patients requiring immediate revision surgery (as defined by attending surgeon)
- Inability of oral drug intake or missing support to guarantee oral drug intake
Sites / Locations
- St. Michael's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Tranexamic Acid Arm
Control Arm
Tranexamic Acid 500 milligrams (MG) Participants of the Tranexamic Acid (TXA) arm will receive the study drug, TXA. Participants of average body weight (60-100kg) will receive TXA according to a 500mg three times daily (TID) dose regimen. Weight deviations from this range will see dose adjustments as follows: participants <60kg will receive 500mg two times daily (BID), and participants >100kg will receive 1000mg BID.
No intervention Participants in the control arm will not receive any additional intervention, medication, or placebo, and will serve as a comparative arm for the experimental arm.