Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2 (TRACE-2)
Chronic Subdural Hematoma
About this trial
This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring Tranexamic acid, Chronic Subdural Hematoma, Neurosurgery
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of chronic subdural hematoma (CSDH)
- Written informed consent (patient, power of attorney or substitute decision maker)
- Competence to take study medication properly and regularly or access to caregiver 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 GFR ≤ 30 mL/min
- Hematuria, caused by diseases of renal parenchyma
- Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX)
- History of angioplasty with cardiac stent placement, or cardiac (including mechanical) valve placement
- Active history of stroke (hemorrhagic and ischemic), or subarachnoid hemorrhage, within the past 6 months
- Consumption coagulopathy/disseminated intravascular coagulation (DIC) in the last 7 days
- History of malignant brain tumors (glioma, metastasis and others) or seizures within the 6 months
- Contraindication to stopping full therapeutic doses of non-ASA antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery
- Inability of oral drug intake or missing support to guarantee oral drug intake
- SDH as caused by intracranial hypotension resulting from CSF shunt placement
Sites / Locations
- St. Michael's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Tranexamic Acid Arm
Placebo Control Arm
Participants in the experimental arm will receive tranexamic acid (TXA) during surgery for CSDH evacuation with a single 1000mg intraoperative intravenous (IV) dose. Participants with a body weight 60-100kg will also receive a post-operative dose regimen of 500 mg TXA orally, 3 times a day (TID). Weight deviations from this body weight range will be considered with a dose adjustment of 1000mg TXA two times a day (BID) for a body weight >100 kg, and 500 mg TXA BID for body weight <60kg.
Participants in the control arm will placebo according to the same administration regimen.