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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid Arm | Experimental | 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 Comparator | Participants in the control arm will placebo according to the same administration regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid 500 MG | Drug | Tranexamic Acid 500mg oral tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 4-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 12 weeks |
| Rate of adverse events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael D Cusimano, MD, PhD | Contact | (+1)416-864-5312 | injuryprevention@smh.ca | |
| Abdelhakim Khellaf, MD | Contact | (+1)514-961-1953 | abdelhakim.khellaf@mail.utoronto.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michael D Cusimano, MD, PhD | St. Michael's Hospital / University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B1T8 | Canada |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Double-blind
| Placebo |
| Drug |
The placebo will consist of an identical capsule to over-encapsulated tranexamic acid oral tablet entirely filled with microcrystalline cellulose, and sealed. |
|
Adverse events investigated include:
Serious adverse events include:
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| At 4, 8, and 12 weeks |
| 36-Item Short Form Survey (SF-36) | Questionnaire assessing patient quality of life outcome profile | At 4, 8, 12 weeks |
| National Institutes of Health Stroke Scale (NIHSS) | 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. | At 4, 8, and 12 weeks |
| Modified Rankin Scale (mRS) | 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. | At 4, 8, and 12 weeks |
| Markwalder's grading scale (MGS) | 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. | At 4, 8, and 12 weeks |
| Rate of re-operation | Rate of re-operation during study course due to hematoma enlargement or other significant cause | At 4, 8, and 12 weeks |
| Time to reoperation | Time to reoperation during study course due to hematoma enlargement or other significant cause | At 4, 8, and 12 weeks |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |