Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

Adult patients aged more than 18 years, presenting with non- traumatic intracerebral haemorrhage within 4.5 hours of onset of stroke symptoms

Exclusion Criteria:

1. Patients with intracerebral haemorrhage secondary to anticoagulation, thrombolysis, known underlying structural abnormality such as arteriovenous malformation, aneurysm, tumour or venous thrombosis or due to known hereditary coagulation disorders. An underlying structural abnormality does not need to be excluded before enrolment, but where known, patients should not be recruited.

2. Known allergies to Tranexamic Acid.

3. Premorbid modified Rankin scale score >4 at the time of enrollment.

4. Concurrent participation in another drug or device trial.

5. Pre stroke life expectancy <3 months (e.g. advanced metastatic cancer).

6. Glasgow coma scale <7.

7. ICH secondary to trauma.

8. Women pregnant, or breastfeeding at randomization.

9. Planned surgery for ICH within 24 hours.

10. Concurrent or planned treatment with any other haemostatic agents.

11. ICH volume > 60 ml as measured by the ABC/2 method on CT Scan