Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage
1 other identifier
interventional
3,400
1 country
48
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2022
Longer than P75 for phase_4
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 30, 2022
CompletedFirst Submitted
Initial submission to the registry
April 19, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
January 22, 2026
January 1, 2026
4.2 years
April 19, 2023
January 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death
Death at day 30. Absolute difference of 3% between intervention and control arm for the number of participants that expired at day 30
30 days
Secondary Outcomes (4)
Change in hematoma volume
24 hours
Neurological impairment
7 days
modified Rankin Scale (mRS)
90 days
Quality of life EQ-5D
90 days
Study Arms (2)
Intervention Arm
EXPERIMENTALThe 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.
Control Arm
NO INTERVENTIONThe 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.
Interventions
The treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml sodium chloride 0.9 % administered over 45 minutes.
Eligibility Criteria
You may qualify if:
- Adult patients aged more than 18 years, presenting with non- traumatic intracerebral haemorrhage within 4.5 hours of onset of stroke symptoms
You may not qualify if:
- 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).
- Glasgow coma scale (GCS) ⩽5.
- ICH secondary to trauma.
- Women of childbearing potential, pregnant, or breastfeeding at randomization.
- Geographical or other factors that prohibit follow-upto 90 days.
- Concurrent or planned treatment with any other hemostatic agents.
- ICH volume \>60 mL as measured by ABC/2 method.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Christian Medical College and Hospital, Ludhiana, Indialead
- Indian Council of Medical Researchcollaborator
- Sree Chitra Tirunal Institute for Medical Sciences & Technologycollaborator
- Post Graduate Institute of Medical Education and Research, Chandigarhcollaborator
- St. Stephen's Hospital, Delhicollaborator
- All India Institute of Medical Sciencescollaborator
- Amrita Institute of Medical Sciences & Research Centercollaborator
- Kasturba Medical College Manipal, Indiacollaborator
- Institute of Neurosciences Kolkatacollaborator
- Bangur Institute of Neurosciences Kolkata, Indiacollaborator
- Guwahati Neurological Research Center, Guwahati, Indiacollaborator
- Baptist Christian Hospital, Tezpur, Indiacollaborator
- National Institute of Mental Health and Neuro Sciences, Indiacollaborator
- Jawaharlal Institute of Postgraduate Medical Education & Researchcollaborator
- Christian Medical College, Vellore, Indiacollaborator
- CARE Hospitals Hyderabad, Indiacollaborator
- Lalitha Super Specialities Hospital Guntur, Indiacollaborator
- Dr. Ramesh Cardiac and Multispeciality Hospital Guntur, Indiacollaborator
- Government General Hospital Guntur, Indiacollaborator
- Fortis Escorts Hospital Jaipur, Indiacollaborator
- Institute of Medical Sciences of the Banaras Hindu University, Indiacollaborator
- Atal Institute of Medical Super Specilities, (AIMSS) Chamiana, Shimlacollaborator
- All India Institute of Medical Sciences, Bhubaneswarcollaborator
- KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre Balgaum, Indiacollaborator
- Guru Gobind Singh Medical College & Hospitalcollaborator
- PBM Hospital Bikaner, Indiacollaborator
- Shree Krishna Hospital Pramukhswami Medical College Anand, Indiacollaborator
- Apollo Excelcare Hospitals Guwahati, Indiacollaborator
- Manipal Hospital Bangalore, Indiacollaborator
- Artemis Hospital Gurgaon, Indiacollaborator
- Dr. Kamakshi Memorial Hospital Chennai, Indiacollaborator
- Bharati Vidyapeeth DTU Medical College Pune, Indiacollaborator
- Aster MIMS Hospital Calicut, Indiacollaborator
- Holy Spirit Hospital Mumbai, Indiacollaborator
- Sparsh Superspeciality Hospital Bangalore, Indiacollaborator
- King George's Medical University, Lucknow, Indiacollaborator
- Assam Medical College, Dibrugarh, Indiacollaborator
- KG Hospital and Post Graduate Medical Institute Coimbatore, Indiacollaborator
- Tirunelveli Medical College, Tirunelveli, Indiacollaborator
- Santokba Durlabhji Memorial Hospital, Jaipur, Indiacollaborator
- Tezpur Medical College and Hospital, Assam, Indiacollaborator
- Baby Memorial Hospital Calicut, Indiacollaborator
- Institute of Human Behaviour and Allied Sciences Delhi, Indiacollaborator
- The Calcutta Medical Research Institute, Kolkata, Indiacollaborator
- Fortis Hospital Mulund Mumbai, Indiacollaborator
- Government Medical College Trivandrum, Indiacollaborator
- Ruby Hall Clinic, Pune, Indiacollaborator
- Manipal Hospital Goa, Indiacollaborator
Study Sites (48)
Government General Hospital
Guntur, Andhra Pradesh, 522001, India
Lalitha Super Specialty Hospital
Guntur, Andhra Pradesh, 522001, India
Dr Ramesh Cardiac and Multispecialty Hospital
Guntur, Andhra Pradesh, 522004, India
Assam Medical College
Dibrugarh, Assam, 786001, India
Guwahati Neurological Research Center
Guwahati, Assam, 781006, India
Apollo Excelcare Hospitals
Guwahati, Assam, 781033, India
Baptist Christian Hospital
Tezpur, Assam, 784001, India
Tezpur Medical College and Hospital
Tezpur, Assam, 784153, India
Manipal Hospital
Panjim, Goa, 403004, India
Shree Krishna Hospital Pramukhswami Medical College
Anand, Gujarat, 388325, India
Artemis Hospital
Gurgaon, Haryana, 122001, India
All India Institute of Medical Sciences
Bilāspur, Himachal Pradesh, 174001, India
Atal Institute of Medical Super Specilities, (AIMSS) Chamiana
Shimla, Himachal Pradesh, 171001, India
Manipal Hospital
Bangalore, Karnataka, 560017, India
Sparsh Superspeciality Hospital
Bangalore, Karnataka, 560022, India
National Institute of Mental Health and Neuro-Sciences
Bangalore, Karnataka, 560029, India
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, Karnataka, 590010, India
Kasturba Medical College Manipal
Manipal, Karnataka, 576104, India
Baby Memorial Hospital
Calicut, Kerala, 673004, India
ASTER MIMS Hospital
Calicut, Kerala, 673016, India
Amrita Institute for Medical Sciences and Research Center
Kochi, Kerala, 682041, India
Government Medical College Trivandrum
Thiruvananthapuram, Kerala, 695011, India
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram, Kerala, 695011, India
Fortis Hospital Mulund
Mumbai, Maharashtra, 400078, India
Holy Spirit Hospital
Mumbai, Maharashtra, 400093, India
Ruby Hall Clinic
Pune, Maharashtra, 411001, India
Bharati Vidyapeeth DTU Medical College
Pune, Maharashtra, 411043, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029, India
Institute of Human Behaviour and Allied Sciences
New Delhi, National Capital Territory of Delhi, 110095, India
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019, India
Guru Gobind Singh Medical College and Hospital
Farīdkot, Punjab, 151203, India
Christian Medical College and Hospital, Ludhiana, Punjab
Ludhiana, Punjab, 141008, India
PBM Hospital
Bikaner, Rajasthan, 334001, India
Santokba Durlabhji Memorial Hospital
Jaipur, Rajasthan, 302015, India
Fortis Escorts Hospital
Jaipur, Rajasthan, 302017, India
Dr. Kamakshi Memorial Hospital
Chennai, Tamil Nadu, 600100, India
KG Hospital and Post Graduate Medical Institute Coimbatore
Coimbatore, Tamil Nadu, 641018, India
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, Tamil Nadu, 605006, India
Tirunelveli Medical College
Tirunelveli, Tamil Nadu, 627011, India
Christian Medical College Vellore
Vellore, Tamil Nadu, 632517, India
CARE Hospitals
Hyderabad, Telangana, Hyderabad, India
King George's Medical University
Lucknow, Uttar Pradesh, 226003, India
Institute of Medical Sciences of the Banaras Hindu University (BHU)
Varanasi, Uttar Pradesh, 221005, India
Institute of Neurosciences
Kolkata, West Bengal, 700017, India
Bangur Institute of Neurosciences
Kolkata, West Bengal, 700020, India
The Calcutta Medical Research Center
Kolkata, West Bengal, 700027, India
Postgraduate Institute for Medical Education and Research
Chandigarh, 160012, India
St Stephen's Hospital
Delhi, 110054, India
Related Publications (3)
Sprigg N, Flaherty K, Appleton JP, Al-Shahi Salman R, Bereczki D, Beridze M, Christensen H, Ciccone A, Collins R, Czlonkowska A, Dineen RA, Duley L, Egea-Guerrero JJ, England TJ, Krishnan K, Laska AC, Law ZK, Ozturk S, Pocock SJ, Roberts I, Robinson TG, Roffe C, Seiffge D, Scutt P, Thanabalan J, Werring D, Whynes D, Bath PM; TICH-2 Investigators. Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial. Lancet. 2018 May 26;391(10135):2107-2115. doi: 10.1016/S0140-6736(18)31033-X. Epub 2018 May 16.
PMID: 29778325BACKGROUNDMeretoja A, Churilov L, Campbell BC, Aviv RI, Yassi N, Barras C, Mitchell P, Yan B, Nandurkar H, Bladin C, Wijeratne T, Spratt NJ, Jannes J, Sturm J, Rupasinghe J, Zavala J, Lee A, Kleinig T, Markus R, Delcourt C, Mahant N, Parsons MW, Levi C, Anderson CS, Donnan GA, Davis SM. The spot sign and tranexamic acid on preventing ICH growth--AUStralasia Trial (STOP-AUST): protocol of a phase II randomized, placebo-controlled, double-blind, multicenter trial. Int J Stroke. 2014 Jun;9(4):519-24. doi: 10.1111/ijs.12132. Epub 2013 Aug 26.
PMID: 23981692BACKGROUNDPandian JD, Phillips A, Verma SJ, Arora D, Dhasan A, Raju PS, Sylaja PN, Ray BK, Chakraborty U, Johnson J, Sharma PK, Bhoi S, Jha M, Iype T, P C, Khurana D, Ray S, Das D, Kalita N, Adhikari S, Sharma A, Roy J, Sahonta R, Singh S, Chaudhary V, Menon G, Aaron S, Bal D, Dhamija RK, Chaturvedi M, Maheshwari S, Saroja AO, Naik KR, Bhutani N, Dhankhar K, Sharma D, Bhatia R, Gorthi SP, Sarmah B, Pamidimukkala V, Saravanan S, Narayan S, Basumatary LJ, Sundarachary NV, Upputuri AK, Karadan U, Pradeep Kumar VG, Parthasarathy R, Doshi D, Wagh S, Ramakrishnan T, Akhtar S, Desai S, Borah NC, Das R, Mittal G, Jain A, Alapatt PJ, Kulkarni GB, Menon D, Raja P, Puri I, Nambiar V, Yerasu MR, Jaiswal SK, Zirpe K, Gurav S, Sharma S, Kumaravelu S, Benny R, Thakkar V, Pathak A, Kempegowda M, Chander P, Ramrakhiani N, Ks AD, Sarma PS, Huilgol R, Sharma M, Dhaliwal RS. Indian Trial of Tranexamic acid in Spontaneous Intracerebral Hemorrhage study protocol. Int J Stroke. 2025 Jul;20(6):756-762. doi: 10.1177/17474930241307933. Epub 2025 Jan 3.
PMID: 39633570DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeyaraj D Pandian, MD DM
Christian Medical College and Hospital, Ludhiana, Punjab, India
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Open-label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal and Professor, Department of Neurology
Study Record Dates
First Submitted
April 19, 2023
First Posted
May 1, 2023
Study Start
August 30, 2022
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
All information collected from medical records for the study will be stored electronically in a specifically designed database at the Christian Medical College and Hospital, Ludhiana, Punjab, India. Participants information will be identified only by their initials and a study registration number. Any information transferred electronically will be coded to protect confidentiality. All computer records will be password-protected. The study results may be presented at conferences or in scientific publications, but individual participants will not be identifiable. If needed, data will be available in future for other researchers outside the primary research group for secondary purposes, such as meta-analyses, reanalysis, or replication of results.