Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma (TRACE)
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|ClinicalTrials.gov Identifier: NCT03280212|
Recruitment Status : Unknown
Verified September 2017 by Michael Cusimano, St. Michael's Hospital, Toronto.
Recruitment status was: Recruiting
First Posted : September 12, 2017
Last Update Posted : September 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Subdural Hematoma||Drug: Tranexamic Acid 500 MG||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma: A Single-centre, Observer-blinded, Randomized Controlled Trial.|
|Actual Study Start Date :||March 6, 2017|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Experimental: Tranexamic Acid Arm
Tranexamic Acid 500 milligrams (MG)
Participants of the Tranexamic Acid (TXA) arm will receive the study drug, TXA. Participants of average body weight (60-100kg) will receive TXA according to a 500mg three times daily (TID) dose regimen. Weight deviations from this range will see dose adjustments as follows: participants <60kg will receive 500mg two times daily (BID), and participants >100kg will receive 1000mg BID.
Drug: Tranexamic Acid 500 MG
Tranexamic Acid 500mg oral tablets.
Other Name: TXA
No Intervention: Control Arm
Participants in the control arm will not receive any additional intervention, medication, or placebo, and will serve as a comparative arm for the experimental arm.
- Chronic subdural hematoma volume change [ Time Frame: 4-8 weeks, 8-12 weeks ]Change in hematoma volume in mL according to volume measurements made on CT scans comparing CT scan at 4-8 weeks to immediate post-operative CT scan.
- Neurological outcome [ Time Frame: 4-8 weeks, 8-12 weeks ]An assessment of neurological outcome as measured by the National Institutes of Health Stroke Scale (NIHSS)
- Quality of life [ Time Frame: 4-8 weeks, 8-12 weeks ]Participants quality of life as measured on the Health Utilities Index (HUI).
- Quality of life [ Time Frame: 4-8 weeks, 8-12 weeks ]Participants quality of life as measured on the 36-item Short Form Health Survey (SF-36).
- Occurrence of adverse events [ Time Frame: 4-8 weeks, 8-12 weeks ]Safety of the TXA dose regimen by monitoring incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280212
|Contact: Adriana M Workewych, HBScfirstname.lastname@example.org|
|Contact: Stanley Zhangemail@example.com|
|St. Michael's Hospital||Recruiting|
|Toronto, Ontario, Canada, M5B 1W8|
|Contact: Adriana M Workewych, HBSc 416-864-5312 firstname.lastname@example.org|
|Principal Investigator: Michael D Cusimano, Md, PhD|