Evaluating Tranexamic Acid to Treat Symptomatic Subdural Hematoma in Adults 45 and Older

What this Trial Is About

Subdural hematoma SDH is a common condition following head injury where blood collects on the brains surface, causing symptoms like headaches, confusion, weakness, or coma. This research aims to evaluate Tranexamic Acid TXA, a commonly used drug that helps prevent blood clots from breaking down, to see if it can reduce bleeding and improve recovery in patients with symptomatic SDH. The study is a randomized controlled trial including patients aged 45 and older with symptomatic SDH. Participants will be randomly assigned to receive either TXA or a placebo. Both groups receive a single oral or intravenous loading dose within three hours of randomization or before surgery if possible, followed by 500 mg doses three times daily for 45 days. The TXA group receives active drug doses, while the placebo group receives capsules and infusions without active ingredients, matching the schedule and administration method of TXA. During the study, participants will have multiple assessments including quality of life questionnaires measured every two weeks up to 45 days, and additional evaluations up to 180 days. Researchers will track bleeding, surgical interventions, cognitive and physical function, hospital stay length, and adverse events. Blood and surgical samples will be collected to understand how TXA works in these patients. The total monitoring period extends to 180 days after randomization.

The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma