Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2

Unity Health Toronto90 enrolled

Overview

Chronic subdural hematoma (CSDH), a common disease after minor head trauma, is characterized by blood collection in the subdural space, which can result in severe neurological impairment. The current standard of care is the surgical evacuation of CSDH. Although clinical and surgical outcomes are satisfying in most cases, considerable morbidity, mortality and recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach to treat CSDH is desirable. Tranexamic acid (TXA), an antifibrinolytic drug, has been shown to decrease hematoma volume in a small cohort of CSDH patients. The present study is designed to test the hypothesis that TXA can reduce the volume of CSDH. Volume measurements of residual CSDH after burr-hole surgery will be performed to quantify treatment success. The trial is designed as a double-blinded randomized controlled trial, where half of the patients will be assigned to daily intake of TXA, whereas the other half will receive placebo. The primary endpoint is defined as volume change in milliliter after 4-8 weeks of treatment. Secondary endpoints are hematoma volume at 8-12 weeks, patient safety, the number of patients with resolution of the CSDH after 4-8 and 8-12 weeks of study participation, the neurological outcome, the rate of reoperation, the time to reoperation, drug safety and compatibility, and participant quality of life (QOL).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Subdural Hematoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Chronic subdural hematoma volume change

Change in hematoma volume in mL according to CT-scan-based volume measurements comparing hematoma on CT scan performed at 4-8 weeks to hematoma on immediate post-operative CT scan.

Time frame: At 4-8 weeks

Secondary Outcomes

Chronic subdural hematoma volume change

Change in hematoma volume in mL according to CT-scan-based volume measurements comparing hematoma on CT scan performed at 4-8 weeks to hematoma on immediate post-operative CT scan.

Time frame: At 12 weeks

Rate of adverse events (AEs)

Adverse events investigated include: * suspected stroke * myocardial infarction * deep vein thrombosis * thromboembolic events * decline in renal function * new-onset neurological deterioration Serious adverse events include: * evidence of stroke * myocardial infarction * deep vein thrombosis * thromboembolic events * convulsions * severe allergic reactions * evidence of retinal degeneration * necessity of hospital admission * mortality