Tezpur

Researchers are evaluating whether Tranexamic Acid can improve outcomes in adults who have experienced spontaneous intracerebral hemorrhage (a type of stroke caused by bleeding in the brain). This trial is a Phase 4, multicenter, randomized, open-label study conducted in India, targeting patients who arrive within 4.5 hours of stroke symptom onset. The study aims to address the high burden and mortality associated with this condition, especially due to hematoma expansion early after symptom onset. Previous trials showed reduced hematoma growth but no clear improvement in functional outcomes, so this larger study seeks to clarify Tranexamic Acid's effect when given early. Participants will be randomly assigned to one of two groups: the treatment group will receive an intravenous dose of 2 grams of Tranexamic Acid diluted in 100 ml of sodium chloride 0.9%, given over 45 minutes. The control group will receive standard care according to hospital protocols. Both groups will undergo intensive blood pressure management to keep systolic pressure below 140 mmHg within one hour, maintained for seven days, using antihypertensive medications chosen by the treating clinician. Repeat brain CT scans will be done 24 hours after treatment to monitor hematoma volume, and urgent imaging will be performed if neurological deterioration occurs. Throughout the study, patients will be closely monitored with neurological assessments on day 7 using NIH Stroke Scale and modified Rankin Scale scores. At 90 days, researchers will evaluate quality of life and functional outcomes. Blood pressure medication usage and doses will be recorded during the first week. The primary outcome measured is death within 30 days. The study plans to enroll 3400 patients across 50 stroke centers in India, with follow-up lasting at least 90 days after treatment.