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.
None
Patients with ICH secondary to anticoagulation, thrombolysis, or known underlying structural abnormality such as arteriovenous malformation, aneurysm, tumor, venous thrombosis or due to known hereditary coagulation disorders.
Contraindication to TXA.
Concurrent participation in another trial.
Pre-stroke life expectancy <3 months (e.g. advanced metastatic cancer).
Christian Medical College and Hospital, Ludhiana, India
Lead sponsor
Indian Council of Medical Research
Collaborator
Sree Chitra Tirunal Institute for Medical Sciences & Technology
Collaborator
Post Graduate Institute of Medical Education and Research, Chandigarh
Collaborator
St. Stephen's Hospital, Delhi
Collaborator
All India Institute of Medical Sciences
Collaborator
Amrita Institute of Medical Sciences & Research Center
Collaborator
Kasturba Medical College Manipal, India
Collaborator
Institute of Neurosciences Kolkata
Collaborator
Bangur Institute of Neurosciences Kolkata, India
Collaborator
Guwahati Neurological Research Center, Guwahati, India
Collaborator
Baptist Christian Hospital, Tezpur, India
Collaborator
National Institute of Mental Health and Neuro Sciences, India
Collaborator
Jawaharlal Institute of Postgraduate Medical Education & Research
Collaborator
Christian Medical College, Vellore, India
Collaborator
CARE Hospitals Hyderabad, India
Collaborator
Lalitha Super Specialities Hospital Guntur, India
Collaborator
Dr. Ramesh Cardiac and Multispeciality Hospital Guntur, India
Collaborator
Government General Hospital Guntur, India
Collaborator
Fortis Escorts Hospital Jaipur, India
Collaborator
Institute of Medical Sciences of the Banaras Hindu University, India
Collaborator
Atal Institute of Medical Super Specilities, (AIMSS) Chamiana, Shimla
Collaborator
All India Institute of Medical Sciences, Bhubaneswar
Collaborator
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre Balgaum, India
Collaborator
Guru Gobind Singh Medical College & Hospital
Collaborator
PBM Hospital Bikaner, India
Collaborator
Shree Krishna Hospital Pramukhswami Medical College Anand, India
Collaborator
Apollo Excelcare Hospitals Guwahati, India
Collaborator
Manipal Hospital Bangalore, India
Collaborator
Artemis Hospital Gurgaon, India
Collaborator
Dr. Kamakshi Memorial Hospital Chennai, India
Collaborator
Bharati Vidyapeeth DTU Medical College Pune, India
Collaborator
Aster MIMS Hospital Calicut, India
Collaborator
Holy Spirit Hospital Mumbai, India
Collaborator
Sparsh Superspeciality Hospital Bangalore, India
Collaborator
King George's Medical University, Lucknow, India
Collaborator
Assam Medical College, Dibrugarh, India
Collaborator
KG Hospital and Post Graduate Medical Institute Coimbatore, India
Collaborator
Tirunelveli Medical College, Tirunelveli, India
Collaborator
Santokba Durlabhji Memorial Hospital, Jaipur, India
Collaborator
Tezpur Medical College and Hospital, Assam, India
Collaborator
Baby Memorial Hospital Calicut, India
Collaborator
Institute of Human Behaviour and Allied Sciences Delhi, India
Collaborator
The Calcutta Medical Research Institute, Kolkata, India
Collaborator
Fortis Hospital Mulund Mumbai, India
Collaborator
Government Medical College Trivandrum, India
Collaborator
Ruby Hall Clinic, Pune, India
Collaborator
Manipal Hospital Goa, India
Collaborator