Abstract

Rationale Early mortality in intracerebral haemorrhage (ICH) is due to haematoma volume (HV) expansion and there are no effective treatments available other than reduction in blood pressure. Tranexamic acid (TXA) a hemostatic drug which is widely available and safe can be a cost-effective treatment for ICH, if proven efficacious. Hypothesis: Administration of TXA in ICH patients when given within 4.5 hours of symptom onset will reduce early mortality at 30 days. Design: Indian Trial of Tranexamic acid in Spontaneous Intracerebral Haemorrhage (INTRINSIC Trial) is a multicenter, randomized, open-label, trial enrolling patients aged more than 18 years presenting with non-traumatic ICH within 4.5 hours of symptom onset or when last seen well. Study participants receive 2 grams of TXA administered within 45 minutes while control group receives standard of care. Intensive blood pressure reduction as per INTERACT 2 protocol is followed in done in both groups. Study plans to recruit 3400 patients. Primary outcome is mortality at day 30. Secondary outcomes are radiological reduction of HV at 24 hours from baseline, neurological impairment at day 7 or earlier (if discharged), and assessments of dependency and quality of life at day 90. Summary: If proven to be beneficial, TXA will have a major impact on medical management of ICH. Trial registration: Clinical Trial Registry India (CTRI/2023/03/050224) and Clinical Trials.gov (NCT05836831)