Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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).