Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage
Status:
Recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Christian Medical College and Hospital, Ludhiana, India
Collaborators:
All India Institute of Medical Sciences, Bhubaneswar All India Institute of Medical Sciences, Bilaspur, India All India Institute of Medical Sciences, New Delhi Amrita Institute of Medical Sciences & Research Center Apollo Excelcare Hospitals Guwahati, India Artemis Hospital Gurgaon, India Assam Medical College Aster MIMS Hospital Calicut, India Atal Institute of Medical Super Specilities, (AIMSS) Chamiana, Shimla Baby Memorial Hospital Calicut, India Bangur Institute of Neurosciences Kolkata, India Baptist Christian Hospital, Tezpur, India Bharati Vidyapeeth DTU Medical College Pune, India CARE Hospitals Hyderabad, India Christian Medical College, Vellore, India Dr. Kamakshi Memorial Hospital Chennai, India Dr. Ramesh Cardiac and Multispeciality Hospital Guntur, India Fortis Escorts Hospital Jaipur, India Fortis Hospital Mulund Mumbai, India Government General Hospital Guntur, India Government Medical College Trivandrum, India Guru Gobind Singh Medical College & Hospital Guwahati Neurological Research Center, Guwahati, India Holy Spirit Hospital Mumbai, India Indian Council of Medical Research Institute of Human Behaviour and Allied Sciences Delhi, India Institute of Medical Sciences of the Banaras Hindu University (BHU),India Institute of Neurosciences Kolkata Jawaharlal Institute of Postgraduate Medical Education & Research Kasturba Medical College Manipal, India KG Hospital and Post Graduate Medical Institute Coimbatore, India King George's Medical University KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre Balgaum, India Lalitha Super Specialities Hospital Guntur, India Manipal Hospital Bangalore, India Manipal Hospital Goa, India National Institute of Mental Health and Neuro Sciences, India PBM Hospital Bikaner, India Postgraduate Institute of Medical Education and Research, Chandigarh Ruby Hall Clinic, Pune, India Santokba Durlabhji Memorial Hospital Shree Krishna Hospital Pramukhswami Medical College Anand, India Sparsh Superspeciality Hospital Bangalore, India Sree Chitra Tirunal Institute for Medical Sciences & Technology St. Stephen's Hospital, Delhi Tezpur Medical College and Hospital, Assam, India The Calcutta Medical Research Institute Tirunelveli Medical College, Tirunelveli, India