The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma
Status:
Not yet recruiting
Trial end date:
2027-03-01
Target enrollment:
Participant gender:
Summary
Subdural hematoma (SDH) is a common condition experienced after head injury. Blood collects
on the surface of the brain, causing headaches which can progress to confusion, weakness, or
even coma. While patients with SDH often receive surgery, not all patients require surgery
right away to ease pressure on the brain. After surgery, there can be up to 30 percent chance
of more bleeding and the need for more surgeries. Given this, a drug capable of lowering the
chance of more bleeding and speeding the recovery of the patient is highly desirable. In this
study, we will test a commonly used, cheap drug called Tranexamic Acid (TXA). While the body
stops unwanted and sometimes dangerous bleeding naturally by forming blood clots, TXA stops
these blood clots from breaking down, which helps to keep bleeding spots plugged. Our
previous study showed that TXA helped speed up patients' recovery; but a larger number of
patients is necessary to evaluate how well TXA works to reduce bleeding and improve
patient-reported outcomes. In this study, regardless of the need for surgery, half of the
patients will be randomly assigned to take TXA, while the other half will take a placebo,
which is a look-alike substance that contains no active drug. We will measure multiple
outcomes over time to determine if TXA is working and lowers healthcare and personal costs,
while also taking blood and surgical samples, to better understand how this drug works in SDH
patients.
Phase:
Phase 3
Details
Lead Sponsor:
Michael Cusimano
Collaborators:
Applied Health Research Centre Canadian Institutes of Health Research (CIHR) The Physicians' Services Incorporated Foundation