Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage

This multicenter, pragmatic randomized, open-label clinical trial aims to assess whether Tranexamic Acid improves outcomes in adult patients with spontaneous intracerebral haemorrhage. The participants presenting within 4.5 hours of the onset of symptoms of stroke with intracerebral haemorrhage confirmed on Computed Tomography (CT Scan) will be randomized into two groups in a 1:1 ratio using a central online randomization. The treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml 0.9% sodium chloride administered over 45 minutes. Control arm patients will receive standard of care treatment as per the institutional protocol. In both arms, intensive systolic blood pressure reduction to less than 140 mmHg will be done using antihypertensive medications, which has to be achieved within one hour and will be maintained over next seven days. The choice of antihypertensive drug will depend on the clinician's preference. Both groups will have a repeat CT scan after 24 hours to check for any increase in the haematoma volume. Any deterioration in the neurological status will warrant urgent brain imaging. On day 7, the patient will be assessed for their NIHSS score and mRS score. On day 90, quality of life and the functional outcome will be assessed.

NCT Number	NCT05836831
Lead Sponsor	Christian Medical College and Hospital, Ludhiana, India Collaborators: Indian Council of Medical Research, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Post Graduate Institute of Medical Education and Research, Chandigarh, St. Stephen's Hospital, Delhi, All India Institute of Medical Sciences, Amrita Institute of Medical Sciences & Research Center, Kasturba Medical College Manipal, India, Institute of Neurosciences Kolkata, Bangur Institute of Neurosciences Kolkata, India, Guwahati Neurological Research Center, Guwahati, India, Baptist Christian Hospital, Tezpur, India, National Institute of Mental Health and Neuro Sciences, India, Jawaharlal Institute of Postgraduate Medical Education & Research, Christian Medical College, Vellore, India, CARE Hospitals Hyderabad, India, Lalitha Super Specialities Hospital Guntur, India, Dr. Ramesh Cardiac and Multispeciality Hospital Guntur, India, Government General Hospital Guntur, India, Fortis Escorts Hospital Jaipur, India, Institute of Medical Sciences of the Banaras Hindu University, India, Atal Institute of Medical Super Specilities, (AIMSS) Chamiana, Shimla, All India Institute of Medical Sciences, Bhubaneswar, KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre Balgaum, India, Guru Gobind Singh Medical College & Hospital, PBM Hospital Bikaner, India, Shree Krishna Hospital Pramukhswami Medical College Anand, India, Apollo Excelcare Hospitals Guwahati, India, Manipal Hospital Bangalore, India, Artemis Hospital Gurgaon, India, Dr. Kamakshi Memorial Hospital Chennai, India, Bharati Vidyapeeth DTU Medical College Pune, India, Aster MIMS Hospital Calicut, India, Holy Spirit Hospital Mumbai, India, Sparsh Superspeciality Hospital Bangalore, India, King George's Medical University, Lucknow, India, Assam Medical College, Dibrugarh, India, KG Hospital and Post Graduate Medical Institute Coimbatore, India, Tirunelveli Medical College, Tirunelveli, India, Santokba Durlabhji Memorial Hospital, Jaipur, India, Tezpur Medical College and Hospital, Assam, India, Baby Memorial Hospital Calicut, India, Institute of Human Behaviour and Allied Sciences Delhi, India, The Calcutta Medical Research Institute, Kolkata, India, Fortis Hospital Mulund Mumbai, India, Government Medical College Trivandrum, India, Ruby Hall Clinic, Pune, India, Manipal Hospital Goa, India
Conditions	Intracerebral Hemorrhagic Stroke
Enrollment	3,400 participants
Start Date	2022-08-30
Primary Completion	2026-11 (estimated)
Study Completion	2026-11 (estimated)
Updated on ClinicalTrials.gov	2026-01-22