Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma
Status:
Unknown status
Trial end date:
2018-03-01
Target enrollment:
Participant gender:
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 can result in severe neurological impairment. Current standard of care is the
evacuation of the CSDH by means of different surgical approaches. Although clinical and
surgical outcomes are satisfying in most cases, considerable morbidity and mortality as well
as recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach for
the treatment of CSDH would be desirable. Tranexamic acid (TXA), an antifibrinolytic drug has
been shown to decrease hematoma volume in a small cohort of patients suffering from CSDH. 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 during study
course to quantify treatment success. The trial is designed as a randomized controlled pilot
study, where half of the patients will be assigned to daily intake of TXA, whereas the other
half will receive medical treatment according to current practice without TXA prescription.
The primary endpoint of the study is defined as volume change in milliliters (mL) after 4-8
weeks of treatment. Secondary endpoints are hematoma volume change at 8-12 weeks, the rate of
patients with resolution of the CSDH after 4-8 weeks and 8-12 weeks days, as well as the rate
of reoperation during study course due to hematoma extension and neurological deterioration.
Additionally the neurological outcome and the drug compatibility will be estimated as
secondary objectives.
Phase:
Phase 3
Details
Lead Sponsor:
St. Michael's Hospital, Toronto Unity Health Toronto