Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage

Status: Recruiting
Location: See all (48) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

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

Locations
Other Locations
India
Shree Krishna Hospital Pramukhswami Medical College
RECRUITING
Anand
Manipal Hospital
NOT_YET_RECRUITING
Bangalore
National Institute of Mental Health and Neuro-Sciences
NOT_YET_RECRUITING
Bangalore
Sparsh Superspeciality Hospital
RECRUITING
Bangalore
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
RECRUITING
Belagavi
All India Institute of Medical Sciences
RECRUITING
Bhubaneswar
PBM Hospital
RECRUITING
Bikaner
All India Institute of Medical Sciences
RECRUITING
Bilāspur
ASTER MIMS Hospital
RECRUITING
Calicut
Baby Memorial Hospital
RECRUITING
Calicut
Postgraduate Institute for Medical Education and Research
RECRUITING
Chandigarh
Dr. Kamakshi Memorial Hospital
RECRUITING
Chennai
KG Hospital and Post Graduate Medical Institute Coimbatore
RECRUITING
Coimbatore
St Stephen's Hospital
RECRUITING
Delhi
Assam Medical College
RECRUITING
Dibrugarh
Guru Gobind Singh Medical College and Hospital
RECRUITING
Farīdkot
Dr Ramesh Cardiac and Multispecialty Hospital
RECRUITING
Guntur
Government General Hospital
RECRUITING
Guntur
Lalitha Super Specialty Hospital
RECRUITING
Guntur
Artemis Hospital
RECRUITING
Gurgaon
Apollo Excelcare Hospitals
RECRUITING
Guwahati
Guwahati Neurological Research Center
RECRUITING
Guwahati
CARE Hospitals
RECRUITING
Hyderabad
Fortis Escorts Hospital
RECRUITING
Jaipur
Santokba Durlabhji Memorial Hospital
RECRUITING
Jaipur
Amrita Institute for Medical Sciences and Research Center
RECRUITING
Kochi
Bangur Institute of Neurosciences
RECRUITING
Kolkata
Institute of Neurosciences
RECRUITING
Kolkata
The Calcutta Medical Research Center
RECRUITING
Kolkata
King George's Medical University
RECRUITING
Lucknow
Christian Medical College and Hospital, Ludhiana, Punjab
RECRUITING
Ludhiana
Kasturba Medical College Manipal
RECRUITING
Manipal
Fortis Hospital Mulund
RECRUITING
Mumbai
Holy Spirit Hospital
RECRUITING
Mumbai
All India Institute of Medical Sciences
RECRUITING
New Delhi
Institute of Human Behaviour and Allied Sciences
RECRUITING
New Delhi
Manipal Hospital
NOT_YET_RECRUITING
Panjim
Jawaharlal Institute of Postgraduate Medical Education and Research
RECRUITING
Puducherry
Bharati Vidyapeeth DTU Medical College
RECRUITING
Pune
Ruby Hall Clinic
RECRUITING
Pune
Atal Institute of Medical Super Specilities, (AIMSS) Chamiana
RECRUITING
Shimla
Baptist Christian Hospital
RECRUITING
Tezpur
Tezpur Medical College and Hospital
RECRUITING
Tezpur
Government Medical College Trivandrum
RECRUITING
Thiruvananthapuram
Sree Chitra Tirunal Institute for Medical Sciences and Technology
RECRUITING
Thiruvananthapuram
Tirunelveli Medical College
RECRUITING
Tirunelveli
Institute of Medical Sciences of the Banaras Hindu University (BHU)
RECRUITING
Varanasi
Christian Medical College Vellore
RECRUITING
Vellore
Contact Information
Primary
Jeyaraj D Pandian, MD DM
jeyarajpandian@hotmail.com
9915784750
Backup
Atul Phillips, MD FNB
atulphillips@yahoo.co.in
9999464983
Time Frame
Start Date: 2022-08-30
Estimated Completion Date: 2026-11
Participants
Target number of participants: 3400
Treatments
Experimental: Intervention Arm
The treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml sodium chloride 0.9 % administered over 45 minutes. Intensive systolic blood pressure reduction to less than 140 mmHg will be done using antihypertensive agents (intravenous and/or oral) which is to be achieved within one hour and has to be maintained over seven days. BP monitoring is done every 15 minutes in the first hour and thereafter every hour for the next six hours after the initiation of intensive BP control. The choice of antihypertensive will depend on the clinician's preference.
No_intervention: Control Arm
The control arm will receive a standard of care management as per the institutional practice. Intensive systolic blood pressure reduction to less than 140 mmHg will be done using antihypertensive (intravenous and/or oral) which is to be achieved within one hour and has to be maintained over seven days. BP monitoring is done for every 15 minutes in the first hour and thereafter every hour for the next six hours after the initiation of intensive BP control. The choice of antihypertensive will depend on the clinician's preference.
Related Therapeutic Areas
Sponsors
Collaborators: Jawaharlal Institute of Postgraduate Medical Education & Research, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Manipal Hospital Bangalore, India, Apollo Excelcare Hospitals Guwahati, India, Government Medical College Trivandrum, India, Baby Memorial Hospital Calicut, India, Post Graduate Institute of Medical Education and Research, Chandigarh, The Calcutta Medical Research Institute, Kolkata, India, King George's Medical University, Lucknow, India, Ruby Hall Clinic, Pune, India, Institute of Human Behaviour and Allied Sciences Delhi, India, Lalitha Super Specialities Hospital Guntur, India, Fortis Hospital Mulund Mumbai, India, Indian Council of Medical Research, Aster MIMS Hospital Calicut, India, All India Institute of Medical Sciences, National Institute of Mental Health and Neuro Sciences, India, Manipal Hospital Goa, India, Bharati Vidyapeeth DTU Medical College Pune, India, St. Stephen's Hospital, Delhi, PBM Hospital Bikaner, India, Institute of Neurosciences Kolkata, Holy Spirit Hospital Mumbai, India, Tezpur Medical College and Hospital, Assam, India, CARE Hospitals Hyderabad, India, Bangur Institute of Neurosciences Kolkata, India, Tirunelveli Medical College, Tirunelveli, India, Fortis Escorts Hospital Jaipur, India, Guru Gobind Singh Medical College & Hospital, Sparsh Superspeciality Hospital Bangalore, India, Kasturba Medical College Manipal, India, KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre Balgaum, India, KG Hospital and Post Graduate Medical Institute Coimbatore, India, All India Institute of Medical Sciences, Bhubaneswar, Atal Institute of Medical Super Specilities, (AIMSS) Chamiana, Shimla, Government General Hospital Guntur, India, Dr. Ramesh Cardiac and Multispeciality Hospital Guntur, India, Dr. Kamakshi Memorial Hospital Chennai, India, Baptist Christian Hospital, Tezpur, India, Artemis Hospital Gurgaon, India, Institute of Medical Sciences of the Banaras Hindu University, India, Christian Medical College, Vellore, India, Santokba Durlabhji Memorial Hospital, Jaipur, India, Assam Medical College, Dibrugarh, India, Guwahati Neurological Research Center, Guwahati, India, Shree Krishna Hospital Pramukhswami Medical College Anand, India, Amrita Institute of Medical Sciences & Research Center
Leads: Christian Medical College and Hospital, Ludhiana, India

This content was sourced from clinicaltrials.gov