Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage
NCT ID: NCT05836831
Last Updated: 2026-01-22
Study Results
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Basic Information
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RECRUITING
PHASE4
3400 participants
INTERVENTIONAL
2022-08-30
2026-11-30
Brief Summary
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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.
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Detailed Description
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Trial Population:
This multi-centric study will be conducted at 50 stroke centres in India associated with the INSTRuCT Network. All patients presenting with symptoms of stroke to the hospital and admitted to the stroke units will be screened for eligibility and if met, will be included in the study. The INTRINSIC trial intends to recruit 3400 patients.
Trial Design:
INTRINSIC Trial will be a multicenter, randomized, open-label, clinical trial. The participants will be randomized into two groups in a 1:1 ratio using a central database of INSTRuCT central online randomization. The baseline characteristics will be adjusted to stroke severity using the NIHSS score and the volume of haematoma. The treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml sodium chloride 0.9 % administered over 45 minutes. Control arm patients will receive standard of care management as per the institutional protocol. Both groups will have a repeat CT scan after 24 hours to check for any increase in the haematoma volume. Any deterioration in the Glasgow Coma Scale (GCS) will warrant urgent brain CT scans. Antihypertensive drugs used and their doses to control BP will be recorded for up to 7 days. 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.
The need for this study:
The proportion of ICH is high in India and other LMIC's, particularly in Asia. Currently, there are no effective treatments available for sICH. Moreover, Tranexamic Acid is cheap, easily available and easy to administer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Contraindication to TXA.
3. Concurrent participation in another trial.
4. Pre-stroke life expectancy \<3 months (e.g. advanced metastatic cancer).
5. Glasgow coma scale (GCS) ⩽5.
6. ICH secondary to trauma.
7. Women of childbearing potential, pregnant, or breastfeeding at randomization.
8. Geographical or other factors that prohibit follow-upto 90 days.
9. Concurrent or planned treatment with any other hemostatic agents.
10. ICH volume \>60 mL as measured by ABC/2 method.
18 Years
99 Years
ALL
No
Sponsors
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Indian Council of Medical Research
OTHER_GOV
Sree Chitra Tirunal Institute for Medical Sciences & Technology
OTHER_GOV
Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
St. Stephen's Hospital, Delhi
OTHER
All India Institute of Medical Sciences
OTHER
Amrita Institute of Medical Sciences & Research Center
OTHER
Kasturba Medical College Manipal, India
UNKNOWN
Institute of Neurosciences Kolkata
OTHER
Bangur Institute of Neurosciences Kolkata, India
UNKNOWN
Guwahati Neurological Research Center, Guwahati, India
UNKNOWN
Baptist Christian Hospital, Tezpur, India
UNKNOWN
National Institute of Mental Health and Neuro Sciences, India
OTHER
Jawaharlal Institute of Postgraduate Medical Education & Research
OTHER_GOV
Christian Medical College, Vellore, India
OTHER
CARE Hospitals Hyderabad, India
UNKNOWN
Lalitha Super Specialities Hospital Guntur, India
UNKNOWN
Dr. Ramesh Cardiac and Multispeciality Hospital Guntur, India
UNKNOWN
Government General Hospital Guntur, India
UNKNOWN
Fortis Escorts Hospital Jaipur, India
UNKNOWN
Institute of Medical Sciences of the Banaras Hindu University, India
OTHER
Atal Institute of Medical Super Specilities, (AIMSS) Chamiana, Shimla
UNKNOWN
All India Institute of Medical Sciences, Bhubaneswar
OTHER
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre Balgaum, India
UNKNOWN
Guru Gobind Singh Medical College & Hospital
OTHER
PBM Hospital Bikaner, India
UNKNOWN
Shree Krishna Hospital Pramukhswami Medical College Anand, India
UNKNOWN
Apollo Excelcare Hospitals Guwahati, India
UNKNOWN
Manipal Hospital Bangalore, India
UNKNOWN
Artemis Hospital Gurgaon, India
UNKNOWN
Dr. Kamakshi Memorial Hospital Chennai, India
UNKNOWN
Bharati Vidyapeeth DTU Medical College Pune, India
UNKNOWN
Aster MIMS Hospital Calicut, India
UNKNOWN
Holy Spirit Hospital Mumbai, India
UNKNOWN
Sparsh Superspeciality Hospital Bangalore, India
UNKNOWN
King George's Medical University, Lucknow, India
UNKNOWN
Assam Medical College, Dibrugarh, India
UNKNOWN
KG Hospital and Post Graduate Medical Institute Coimbatore, India
UNKNOWN
Tirunelveli Medical College, Tirunelveli, India
UNKNOWN
Santokba Durlabhji Memorial Hospital, Jaipur, India
UNKNOWN
Tezpur Medical College and Hospital, Assam, India
UNKNOWN
Baby Memorial Hospital Calicut, India
UNKNOWN
Institute of Human Behaviour and Allied Sciences Delhi, India
UNKNOWN
The Calcutta Medical Research Institute, Kolkata, India
UNKNOWN
Fortis Hospital Mulund Mumbai, India
UNKNOWN
Government Medical College Trivandrum, India
UNKNOWN
Ruby Hall Clinic, Pune, India
UNKNOWN
Manipal Hospital Goa, India
UNKNOWN
Christian Medical College and Hospital, Ludhiana, India
OTHER
Responsible Party
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Jeyaraj D Pandian
Principal and Professor, Department of Neurology
Principal Investigators
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Jeyaraj D Pandian, MD DM
Role: PRINCIPAL_INVESTIGATOR
Christian Medical College and Hospital, Ludhiana, Punjab, India
Locations
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Government General Hospital
Guntur, Andhra Pradesh, India
Lalitha Super Specialty Hospital
Guntur, Andhra Pradesh, India
Dr Ramesh Cardiac and Multispecialty Hospital
Guntur, Andhra Pradesh, India
Assam Medical College
Dibrugarh, Assam, India
Guwahati Neurological Research Center
Guwahati, Assam, India
Apollo Excelcare Hospitals
Guwahati, Assam, India
Baptist Christian Hospital
Tezpur, Assam, India
Tezpur Medical College and Hospital
Tezpur, Assam, India
Manipal Hospital
Panjim, Goa, India
Shree Krishna Hospital Pramukhswami Medical College
Anand, Gujarat, India
Artemis Hospital
Gurgaon, Haryana, India
All India Institute of Medical Sciences
Bilāspur, Himachal Pradesh, India
Atal Institute of Medical Super Specilities, (AIMSS) Chamiana
Shimla, Himachal Pradesh, India
Manipal Hospital
Bangalore, Karnataka, India
Sparsh Superspeciality Hospital
Bangalore, Karnataka, India
National Institute of Mental Health and Neuro-Sciences
Bangalore, Karnataka, India
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, Karnataka, India
Kasturba Medical College Manipal
Manipal, Karnataka, India
Baby Memorial Hospital
Calicut, Kerala, India
ASTER MIMS Hospital
Calicut, Kerala, India
Amrita Institute for Medical Sciences and Research Center
Kochi, Kerala, India
Government Medical College Trivandrum
Thiruvananthapuram, Kerala, India
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram, Kerala, India
Fortis Hospital Mulund
Mumbai, Maharashtra, India
Holy Spirit Hospital
Mumbai, Maharashtra, India
Ruby Hall Clinic
Pune, Maharashtra, India
Bharati Vidyapeeth DTU Medical College
Pune, Maharashtra, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Institute of Human Behaviour and Allied Sciences
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences
Bhubaneswar, Odisha, India
Guru Gobind Singh Medical College and Hospital
Farīdkot, Punjab, India
Christian Medical College and Hospital, Ludhiana, Punjab
Ludhiana, Punjab, India
PBM Hospital
Bikaner, Rajasthan, India
Santokba Durlabhji Memorial Hospital
Jaipur, Rajasthan, India
Fortis Escorts Hospital
Jaipur, Rajasthan, India
Dr. Kamakshi Memorial Hospital
Chennai, Tamil Nadu, India
KG Hospital and Post Graduate Medical Institute Coimbatore
Coimbatore, Tamil Nadu, India
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, Tamil Nadu, India
Tirunelveli Medical College
Tirunelveli, Tamil Nadu, India
Christian Medical College Vellore
Vellore, Tamil Nadu, India
CARE Hospitals
Hyderabad, Telangana, India
King George's Medical University
Lucknow, Uttar Pradesh, India
Institute of Medical Sciences of the Banaras Hindu University (BHU)
Varanasi, Uttar Pradesh, India
Institute of Neurosciences
Kolkata, West Bengal, India
Bangur Institute of Neurosciences
Kolkata, West Bengal, India
The Calcutta Medical Research Center
Kolkata, West Bengal, India
Postgraduate Institute for Medical Education and Research
Chandigarh, , India
St Stephen's Hospital
Delhi, , India
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Meretoja 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.
Pandian 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.
Other Identifiers
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INTRINSIC Trial
Identifier Type: -
Identifier Source: org_study_id
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