Clinical trial NCT04898712: Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2
Official title: Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma: An Observer-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Subdural Hematoma
Keywords: Tranexamic acid
Chronic Subdural Hematoma
Neurosurgery
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2021-05-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Chronic subdural hematoma volume change
timeFrame: At 4-8 weeks
Secondary outcomes:
measure: Chronic subdural hematoma volume change
timeFrame: At 12 weeks
measure: Rate of adverse events (AEs)
timeFrame: At 4, 8, and 12 weeks
measure: 36-Item Short Form Survey (SF-36)
timeFrame: At 4, 8, 12 weeks
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: At 4, 8, and 12 weeks
measure: Modified Rankin Scale (mRS)
timeFrame: At 4, 8, and 12 weeks
measure: Markwalder's grading scale (MGS)
timeFrame: At 4, 8, and 12 weeks
measure: Rate of re-operation
timeFrame: At 4, 8, and 12 weeks
measure: Time to reoperation
timeFrame: At 4, 8, and 12 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: St. Michael's Hospital / University of Toronto
name: Michael D Cusimano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: