Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2

Chronic Subdural Hematoma Clinical Trial

— TRACE-2  

Official title:

Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma: An Observer-blinded, Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04898712
• Other study ID #: 17-232
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2021
• Est. completion date: December 2023

Study information

• Verified date: May 2021
• Source: Unity Health Toronto
• Contact: Michael D Cusimano, MD, PhD
• Phone: (+1)416-864-5312
• Email: injuryprevention[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Drug:
• Tranexamic Acid 500 MG
Tranexamic Acid 500mg oral tablets
• Placebo
The placebo will consist of an identical capsule to over-encapsulated tranexamic acid oral tablet entirely filled with microcrystalline cellulose, and sealed.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Unity Health Toronto	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Rate of adverse events (AEs)	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; mortality	At 4, 8, and 12 weeks
Secondary	36-Item Short Form Survey (SF-36)	Questionnaire assessing patient quality of life outcome profile	At 4, 8, 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to reoperation	Time to reoperation during study course due to hematoma enlargement or other significant cause	At 4, 8, and 12 weeks