Study of Intravenous Tranexamic Acid for Adults with Spontaneous Intracerebral Hemorrhage Within 4.5 Hours of Stroke Symptoms

What this Trial Is About

Researchers are evaluating whether Tranexamic Acid can improve outcomes in adults who have a spontaneous intracerebral haemorrhage, a type of stroke caused by bleeding within the brain. This trial focuses on patients who arrive within 4.5 hours after stroke symptoms begin. The study is important because this condition has a high risk of death and disability, and early treatment with haemostatic drugs like Tranexamic Acid could potentially reduce bleeding and improve recovery. The trial is conducted across multiple centers in India and aims to enroll 3400 patients. Participants will be randomly assigned to one of two groups. One group receives 2 grams of Tranexamic Acid given intravenously over 45 minutes, along with intensive blood pressure control to maintain systolic pressure below 140 mmHg for seven days. The other group receives standard care with the same blood pressure management protocol. Both groups will have CT brain scans after 24 hours to check for changes in bleeding. Blood pressure is closely monitored every 15 minutes for the first hour and then hourly for six hours. During the study, patients will be assessed using neurological scores on day 7 and their quality of life and functional status will be measured on day 90. Researchers will monitor death rates within 30 days, changes in haematoma size, neurological impairments, and overall recovery. The study includes regular neurological evaluations and brain imaging as needed. Participation lasts at least 90 days to evaluate outcomes and safety.

Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage