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Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage
Sponsor: Christian Medical College and Hospital, Ludhiana, India
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.
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
3400
Start Date
2022-08-30
Completion Date
2026-11
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
Tranexamic acid injection
The treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml sodium chloride 0.9 % administered over 45 minutes.
Locations (48)
Government General Hospital
Guntur, Andhra Pradesh, India
Lalitha Super Specialty Hospital
Guntur, Andhra Pradesh, India
Dr Ramesh Cardiac and Multispecialty Hospital
Guntur, Andhra Pradesh, India
Assam Medical College
Dibrugarh, Assam, India
Guwahati Neurological Research Center
Guwahati, Assam, India
Apollo Excelcare Hospitals
Guwahati, Assam, India
Baptist Christian Hospital
Tezpur, Assam, India
Tezpur Medical College and Hospital
Tezpur, Assam, India
Manipal Hospital
Panjim, Goa, India
Shree Krishna Hospital Pramukhswami Medical College
Anand, Gujarat, India
Artemis Hospital
Gurgaon, Haryana, India
All India Institute of Medical Sciences
Bilāspur, Himachal Pradesh, India
Atal Institute of Medical Super Specilities, (AIMSS) Chamiana
Shimla, Himachal Pradesh, India
Manipal Hospital
Bangalore, Karnataka, India
Sparsh Superspeciality Hospital
Bangalore, Karnataka, India
National Institute of Mental Health and Neuro-Sciences
Bangalore, Karnataka, India
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, Karnataka, India
Kasturba Medical College Manipal
Manipal, Karnataka, India
Baby Memorial Hospital
Calicut, Kerala, India
ASTER MIMS Hospital
Calicut, Kerala, India
Amrita Institute for Medical Sciences and Research Center
Kochi, Kerala, India
Government Medical College Trivandrum
Thiruvananthapuram, Kerala, India
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram, Kerala, India
Fortis Hospital Mulund
Mumbai, Maharashtra, India
Holy Spirit Hospital
Mumbai, Maharashtra, India
Ruby Hall Clinic
Pune, Maharashtra, India
Bharati Vidyapeeth DTU Medical College
Pune, Maharashtra, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Institute of Human Behaviour and Allied Sciences
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences
Bhubaneswar, Odisha, India
Guru Gobind Singh Medical College and Hospital
Farīdkot, Punjab, India
Christian Medical College and Hospital, Ludhiana, Punjab
Ludhiana, Punjab, India
PBM Hospital
Bikaner, Rajasthan, India
Santokba Durlabhji Memorial Hospital
Jaipur, Rajasthan, India
Fortis Escorts Hospital
Jaipur, Rajasthan, India
Dr. Kamakshi Memorial Hospital
Chennai, Tamil Nadu, India
KG Hospital and Post Graduate Medical Institute Coimbatore
Coimbatore, Tamil Nadu, India
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, Tamil Nadu, India
Tirunelveli Medical College
Tirunelveli, Tamil Nadu, India
Christian Medical College Vellore
Vellore, Tamil Nadu, India
CARE Hospitals
Hyderabad, Telangana, India
King George's Medical University
Lucknow, Uttar Pradesh, India
Institute of Medical Sciences of the Banaras Hindu University (BHU)
Varanasi, Uttar Pradesh, India
Institute of Neurosciences
Kolkata, West Bengal, India
Bangur Institute of Neurosciences
Kolkata, West Bengal, India
The Calcutta Medical Research Center
Kolkata, West Bengal, India
Postgraduate Institute for Medical Education and Research
Chandigarh, India
St Stephen's Hospital
Delhi, India