Indian Trial of Tranexamic acid in Spontaneous Intracerebral Hemorrhage study protocol

Abstract

Rationale: Early mortality in intracerebral hemorrhage (ICH) is due to hematoma volume (HV) expansion, and there are no effective treatments available other than reduction in blood pressure. Tranexamic acid (TXA) a hemostatic drug that 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 h 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 h of symptom onset or when last seen well. Study participants received 2 g of TXA administered within 45 min while control group received standard of care. Intensive blood pressure reduction as per INTERACT 2 protocol is followed is done in both groups. Study plans to recruit 3400 patients. Primary outcome is mortality at day 30. Secondary outcomes are radiological reduction in HV at 24 h 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).

Keywords: Intracerebral hemorrhage; hematoma; management; randomized clinical trial; tranexamic acid; volume.