Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2
- Conditions
- Chronic Subdural Hematoma
- Interventions
- Drug: Tranexamic Acid 500 MGDrug: Placebo
- Registration Number
- NCT04898712
- Lead Sponsor
- Unity Health Toronto
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tranexamic Acid Arm Tranexamic Acid 500 MG 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. Placebo Control Arm Placebo Participants in the control arm will placebo according to the same administration regimen.
- Primary Outcome Measures
Name Time Method Chronic subdural hematoma volume change At 4-8 weeks 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.
- Secondary Outcome Measures
Name Time Method Chronic subdural hematoma volume change At 12 weeks 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.
Rate of adverse events (AEs) At 4, 8, and 12 weeks 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
* mortality36-Item Short Form Survey (SF-36) At 4, 8, 12 weeks Questionnaire assessing patient quality of life outcome profile
National Institutes of Health Stroke Scale (NIHSS) At 4, 8, and 12 weeks Change in National Institutes of Health Stroke Scale (NIHSS) score (neurological outcome) at 4-8 weeks and 8-12 weeks, compared to the baseline visit score
Minimum scale score: 0; Maximum scale score: 42. Higher score means worse neurological impairment.Modified Rankin Scale (mRS) At 4, 8, and 12 weeks Change in Modified Rankin Scale (mRS) score (neurological outcome) at 4-8 weeks and 8-12 weeks, compared to the baseline visit score
Minimum scale score: 0 (no symptoms); Maximum scale score: 6 (death). Higher score means worse neurological outcome.Markwalder's grading scale (MGS) At 4, 8, and 12 weeks Change in Markwalder's grading scale (MGS) score (neurological outcome) at 4-8 weeks and 8-12 weeks, compared to the baseline visit score
Minimum scale score: 0 (normal); Maximum scale score: 4. Higher score means worse neurological outcome.Rate of re-operation At 4, 8, and 12 weeks Rate of re-operation during study course due to hematoma enlargement or other significant cause
Time to reoperation At 4, 8, and 12 weeks Time to reoperation during study course due to hematoma enlargement or other significant cause
Trial Locations
- Locations (1)
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada