Status:
UNKNOWN
Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Chronic Subdural Hematoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04898712
Start Date
July 1 2021
End Date
December 1 2023
Last Update
May 24 2021
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1T8