Status:
UNKNOWN
Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma
Lead Sponsor:
Unity Health Toronto
Conditions:
Chronic Subdural Hematoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Chronic subdural hematoma (CSDH) is a common disease after minor head trauma, especially in elderly patients. This medical condition is characterized by blood collection in the subdural space, which c...
Eligibility Criteria
Inclusion
- Patients diagnosed with chronic subdural hematoma, and have a planned or have received a unilateral or bilateral burr-hole craniostomy or mini-craniotomy
- Written informed consent (patient, power of attorney or substitute decision maker)
- Competence to take study medication properly and regularly or access to care giver 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 glomerular filtration rate (GFR) ≤ 30 mL/min
- Hematuria, caused by diseases of renal parenchyma
- Current alcohol abuse (as indicated by an Alcohol Use Disorders Identification Test (AUDIT) score of 10 or higher) drug abuse, or recreational drug use
- Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX)
- Active, history, or increased risk of thrombotic events (including deep vein thrombosis, pulmonary embolism, cerebral venous thrombosis, arterial thrombotic events), symptomatic carotid stenosis, myocardial infarction, acute coronary syndrome, coronary artery disease, or consumption coagulopathy within the past 2 years
- History of angioplasty with cardiac stent placement or mechanical heart valve
- Active or history of brain pathologies such as stroke (hemorrhagic and ischemic), subarachnoid hemorrhage, or malignant brain tumors (glioma, metastasis and others) as well as history of seizures within the past 2 years
- Contraindication to stopping full therapeutic doses of non-acetylsalicylic acid (ASA) antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery
- Patients requiring immediate revision surgery (as defined by attending surgeon)
- Inability of oral drug intake or missing support to guarantee oral drug intake
Key Trial Info
Start Date :
March 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03280212
Start Date
March 6 2017
End Date
March 1 2018
Last Update
September 14 2017
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8