Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage

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.

Conditions

• Intracerebral Hemorrhagic Stroke

Interventions

DRUG

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.

Sponsors & Collaborators

• Indian Council of Medical Research

  collaborator OTHER_GOV

• Sree Chitra Tirunal Institute for Medical Sciences & Technology

  collaborator OTHER_GOV

• Post Graduate Institute of Medical Education and Research, Chandigarh

  collaborator OTHER

• St. Stephen's Hospital, Delhi

  collaborator OTHER

• All India Institute of Medical Sciences

  collaborator OTHER

• Amrita Institute of Medical Sciences & Research Center

  collaborator OTHER

• Kasturba Medical College Manipal, India

  collaborator UNKNOWN

• Institute of Neurosciences Kolkata

  collaborator OTHER

• Bangur Institute of Neurosciences Kolkata, India

  collaborator UNKNOWN

• Guwahati Neurological Research Center, Guwahati, India

  collaborator UNKNOWN

• Baptist Christian Hospital, Tezpur, India

  collaborator UNKNOWN

• National Institute of Mental Health and Neuro Sciences, India

  collaborator OTHER

• Jawaharlal Institute of Postgraduate Medical Education & Research

  collaborator OTHER_GOV

• Christian Medical College, Vellore, India

  collaborator OTHER

• CARE Hospitals Hyderabad, India

  collaborator UNKNOWN

• Lalitha Super Specialities Hospital Guntur, India

  collaborator UNKNOWN

• Dr. Ramesh Cardiac and Multispeciality Hospital Guntur, India

  collaborator UNKNOWN

• Government General Hospital Guntur, India

  collaborator UNKNOWN

• Fortis Escorts Hospital Jaipur, India

  collaborator UNKNOWN

• Institute of Medical Sciences of the Banaras Hindu University, India

  collaborator OTHER

• Atal Institute of Medical Super Specilities, (AIMSS) Chamiana, Shimla

  collaborator UNKNOWN

• All India Institute of Medical Sciences, Bhubaneswar

  collaborator OTHER

• KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre Balgaum, India

  collaborator UNKNOWN

• Guru Gobind Singh Medical College & Hospital

  collaborator OTHER

• PBM Hospital Bikaner, India

  collaborator UNKNOWN

• Shree Krishna Hospital Pramukhswami Medical College Anand, India

  collaborator UNKNOWN

• Apollo Excelcare Hospitals Guwahati, India

  collaborator UNKNOWN

• Manipal Hospital Bangalore, India

  collaborator UNKNOWN

• Artemis Hospital Gurgaon, India

  collaborator UNKNOWN

• Dr. Kamakshi Memorial Hospital Chennai, India

  collaborator UNKNOWN

• Bharati Vidyapeeth DTU Medical College Pune, India

  collaborator UNKNOWN

• Aster MIMS Hospital Calicut, India

  collaborator UNKNOWN

• Holy Spirit Hospital Mumbai, India

  collaborator UNKNOWN

• Sparsh Superspeciality Hospital Bangalore, India

  collaborator UNKNOWN

• King George's Medical University, Lucknow, India

  collaborator UNKNOWN

• Assam Medical College, Dibrugarh, India

  collaborator UNKNOWN

• KG Hospital and Post Graduate Medical Institute Coimbatore, India

  collaborator UNKNOWN

• Tirunelveli Medical College, Tirunelveli, India

  collaborator UNKNOWN

• Santokba Durlabhji Memorial Hospital, Jaipur, India

  collaborator UNKNOWN

• Tezpur Medical College and Hospital, Assam, India

  collaborator UNKNOWN

• Baby Memorial Hospital Calicut, India

  collaborator UNKNOWN

• Institute of Human Behaviour and Allied Sciences Delhi, India

  collaborator UNKNOWN

• The Calcutta Medical Research Institute, Kolkata, India

  collaborator UNKNOWN

• Fortis Hospital Mulund Mumbai, India

  collaborator UNKNOWN

• Government Medical College Trivandrum, India

  collaborator UNKNOWN

• Ruby Hall Clinic, Pune, India

  collaborator UNKNOWN

• Manipal Hospital Goa, India

  collaborator UNKNOWN

• Christian Medical College and Hospital, Ludhiana, India

  lead OTHER

Principal Investigators

• Jeyaraj D Pandian, MD DM · Christian Medical College and Hospital, Ludhiana, Punjab, India

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-30

Primary Completion

2026-11-30

Completion

2026-11-30

Countries

• India

Study Locations