Intracerebral Hemorrhagic StrokePhase 4NCT05836831
Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage
A Phase 4 study testing Tranexamic acid injection in people with Intracerebral Hemorrhagic Stroke, run by Christian Medical College and Hospital, Ludhiana, India at 48 sites in India.
Trial summary
This multicenter, pragmatic randomized, open-label clinical trial aims to assess whether Tranexamic Acid improves outcomes in adult patients with spontaneous intracerebral haemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Intracerebral Hemorrhagic Stroke
- What is being tested?
- Tranexamic acid injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,400 participants
- Where
- 48 sitesIndia
- Study dates
- 30 Aug 2022to Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged more than 18 years, presenting with non- traumatic intracerebral haemorrhage within 4.5 hours of onset of stroke symptoms
Who cannot join
- 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.
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- 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.
Trial locations and contacts
48 sites in 1 country. Contact the study team or a site near you to ask about taking part.
48 sites in 1 country
India48 sites, 48 recruiting
- Recruiting
Shree Krishna Hospital Pramukhswami Medical College
Anand, Gujarat, 388325
Soaham Desai, MD DM, 9979937885, drsoahamdesai@yahoo.com
Soaham Desai, MD DM
- Not yet recruiting
Manipal Hospital
Bangalore, Karnataka, 560017
Pramod Krishnan, MD DM, 8971599998, pramod.krishnan@manipalhospitals.com
Pramod Krishnan, MD DM
- Recruiting
Sparsh Superspeciality Hospital
Bangalore, Karnataka, 560022
Madhusudhan B Kempegowda, MD DM, 9902078244, drmadhubk@gmail.com
Madhusudhan B Kempegowda, MD DM
- Not yet recruiting
National Institute of Mental Health and Neuro-Sciences
Bangalore, Karnataka, 560029
Girish B Kulkarni, MD DM, 9035160614, gbk5000@rediffmail.com
Girish B Kulkarni, MD DM
- Recruiting
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, Karnataka, 590010
Aralikatte O Saroja, MD DM, 9448468474, sarojaao2002@yahoo.com
Aralikatte O Saroja, MD DM
- Recruiting
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019
Sanjeev K Bhoi, DM,PDF, 9919787978, neuro_sanjeev@aiimsbhubaneswar.edu.in
Sanjeev K Bhoi, DM,PDF
- Recruiting
PBM Hospital
Bikaner, Rajasthan, 334001
Inder Puri, MD DM, 7023266560, dr.inderpuri@gmail.com
Inder Puri, MD DM
- Recruiting
All India Institute of Medical Sciences
Bilāspur, Himachal Pradesh, 174001
Ashish Sharma, MD DM, 98163 97700, ashishsharmamd@yahoo.co.in
Ashish Sharma, MD DM
- Recruiting
Baby Memorial Hospital
Calicut, Kerala, 673004
Ummer Karadan, MD DM, 94478 43954, ummerneuro1@gmail.com
Ummer Karadan, MD DM
- Recruiting
ASTER MIMS Hospital
Calicut, Kerala, 673016
Paul J Alapatt, DM, PDF, 9447342034, pauljalapatt@gmail.com
Paul J Alapatt, DM, PDF
- Recruiting
Postgraduate Institute for Medical Education and Research
Chandigarh, 160012
Dheeraj Khurana, MD DM, 7087009695, dherajk@yahoo.com
Dheeraj Khurana, MD DM
- Recruiting
Dr. Kamakshi Memorial Hospital
Chennai, Tamil Nadu, 600100
Parveen Chander, MD DM, 9444472722, drnpcmd@gmail.com
Parveen Chander, MD DM
- Recruiting
KG Hospital and Post Graduate Medical Institute Coimbatore
Coimbatore, Tamil Nadu, 641018
TCR Ramakrishnan, MD DM, 9443365792, kgneuro@gmail.com
TCR Ramakrishnan, MD DM
- Recruiting
St Stephen's Hospital
Delhi, 110054
Gaurav K Mittal, MD DM, 7042877975, drgkmittal@gmail.com
Gaurav K Mittal, MD DM
- Recruiting
Assam Medical College
Dibrugarh, Assam, 786001
Binod Sarmah, MD DM, 9577631327, b_sarmah2007@yahoo.com
Binod Sarmah, MD DM
- Recruiting
Guru Gobind Singh Medical College and Hospital
Farīdkot, Punjab, 151203
Sulena Sulena, MD DM, 7087907025, sulenasingh@yahoo.co.in
Sulena Sulena, MD DM
- Recruiting
Government General Hospital
Guntur, Andhra Pradesh, 522001
Sundarachary Nagarjunakonda, MD DM, 9440257675, sundarachary@yahoo.com
Sundarachary Nagarjunakonda, MD DM
- Recruiting
Lalitha Super Specialty Hospital
Guntur, Andhra Pradesh, 522001
Vijaya Pamidimukkala, MD DM, 9440808621, drvijayapvr@gmail.com
Vijaya Pamidimukkala, MD DM
- Recruiting
Dr Ramesh Cardiac and Multispecialty Hospital
Guntur, Andhra Pradesh, 522004
Somasundaram Kumaravelu, MD DM, 9553651777, neurovelu@gmail.com
Somasundaram Kumaravelu, MD DM
- Recruiting
Artemis Hospital
Gurgaon, Haryana, 122001
Rajsrinivas Parthasarathy, MBBS MRCP, 8826007421, rajsrinivasp@yahoo.co.in
Rajsrinivas Parthasarathy, MBBS MRCP
- Recruiting
Guwahati Neurological Research Center
Guwahati, Assam, 781006
Nomal C Borah, MD DM, 9706050234, ncborah@gnrchospitals.com
Nomal C Borah, MD DM
- Recruiting
Apollo Excelcare Hospitals
Guwahati, Assam, 781033
Lakshya J Basumatary, MD DM, 9954480668, drbasumatary@gmail.com
Lakshya J Basumatary, MD DM
- Recruiting
CARE Hospitals
Hyderabad, Telangana, Hyderabad
Yerasu M Reddy, DM DNB, 9912329342, muralidharnims@gmail.com
Yerasu M Reddy, DM DNB
- Recruiting
Santokba Durlabhji Memorial Hospital
Jaipur, Rajasthan, 302015
Neeraj Bhutani, DM, 98287 11808, drneerajbhutani@rediffmail.com
Neeraj Bhutani, DM
- Recruiting
Fortis Escorts Hospital
Jaipur, Rajasthan, 302017
Neetu Ramrakhiani, MD DM DNB, 9314932648, neetudilip@yahoo.co.in
Neetu Ramrakhiani, MD DM DNB
- Recruiting
Amrita Institute for Medical Sciences and Research Center
Kochi, Kerala, 682041
Vivek K Nambiar, MD DM, 8921485541, vivek19602@aims.amrita.edu
Vivek K Nambiar, MD DM
- Recruiting
Institute of Neurosciences
Kolkata, West Bengal, 700017
Jayanta Roy, MD DM, 9903048154, jroyneuro01@gmail.com
Jayanta Roy, MD DM
- Recruiting
Bangur Institute of Neurosciences
Kolkata, West Bengal, 700020
Biman K Ray, MD DM, 9433185327, biman.kanti@rediffmail.com
Biman K Ray, MD DM
- Recruiting
The Calcutta Medical Research Center
Kolkata, West Bengal, 700027
Sujoy Mukherjee, MD FNB, 9330960230, drsujoym@gmail.com
Sujoy Mukherjee, MD FNB
- Recruiting
King George's Medical University
Lucknow, Uttar Pradesh, 226003
Parveen K Sharma, MD DM, 7388111289, pspgimer@gmail.com
Parveen K Sharma, MD DM
- Recruiting
Christian Medical College and Hospital, Ludhiana, Punjab
Ludhiana, Punjab, 141008
Jeyaraj D Pandian, MD DM, 9915784750, jeyarajpandian@hotmail.com
Jeyaraj D Pandian, MD DM
- Recruiting
Kasturba Medical College Manipal
Manipal, Karnataka, 576104
Girish Menon, MBBS MCh, 7760563666, girish.menon@manipal.edu
Girish Menon, MBBS MCh
- Recruiting
Fortis Hospital Mulund
Mumbai, Maharashtra, 400078
Rajesh Benny, DNB DM, 9820410322, rajeshbenny@gmail.com
Rajesh Benny, DNB DM
- Recruiting
Holy Spirit Hospital
Mumbai, Maharashtra, 400093
Darshan Doshi, MD DM, 9845633469, darshankdoshi@gmail.com
Darshan Doshi, MD DM
- Recruiting
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Rohit Bhatia, MD DM, 98912 67417, rohitbhatia71@yahoo.com
Rohit Bhatia, MD DM
- Recruiting
Institute of Human Behaviour and Allied Sciences
New Delhi, National Capital Territory of Delhi, 110095
Rajinder K Dhamija, MD DNB, 99908 86679, director@ihbas.org
Rajinder K Dhamija, MD DNB
- Not yet recruiting
Manipal Hospital
Panjim, Goa, 403004
Parul Dubey, MD DM, 9552530337, drdubeyparul@gmail.com
Parul Dubey, MD DM
- Recruiting
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, Tamil Nadu, 605006
Sunil K Narayan, DM, PhD, 9443617120, sknarayan@gmail.com
Sunil K Narayan, DM, PhD
- Recruiting
Ruby Hall Clinic
Pune, Maharashtra, 411001
Kapil Zirpe, MBBS MD, 9822844212, kapilzirpe@gmail.com
Kapil Zirpe, MBBS MD
- Recruiting
Bharati Vidyapeeth DTU Medical College
Pune, Maharashtra, 411043
Sankar P Gorthi, MD DM, 8800233991, pgorthi2002@yahoo.com
Sankar P Gorthi, MD DM
- Recruiting
Atal Institute of Medical Super Specilities, (AIMSS) Chamiana
Shimla, Himachal Pradesh, 171001
Sudhir Sharma, MD DM, 9418523202, sharmasudhir21@gmail.com
Sudhir Sharma, MD DM
- Recruiting
Baptist Christian Hospital
Tezpur, Assam, 784001
Jacob Johnson, MD, 7598626847, cooljacky44@gmail.com
Jacob Johnson, MD
- Recruiting
Tezpur Medical College and Hospital
Tezpur, Assam, 784153
Dwijen Das, MD, 9435181953, drdwijendas@yahoo.co.in
Dwijen Das, MD
- Recruiting
Government Medical College Trivandrum
Thiruvananthapuram, Kerala, 695011
Thomas Iype, MD DM, 94462 30317, drthomasiypeneuro@gmail.com
Thomas Iype, MD DM
- Recruiting
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram, Kerala, 695011
Padmavathyamma N Sylaja, MD DM, 9446566287, sylajapn@hotmail.com
Padmavathyamma N Sylaja, MD DM
- Recruiting
Tirunelveli Medical College
Tirunelveli, Tamil Nadu, 627011
S Saravanan, MD DM, 9842909451, drsaravananneuro@gmail.com
S Saravanan, MD DM
- Recruiting
Institute of Medical Sciences of the Banaras Hindu University (BHU)
Varanasi, Uttar Pradesh, 221005
Abhishek Pathak, MD DM, 8948512666, abhishekpathakaiims@gmail.com
Abhishek Pathak, MD DM
- Recruiting
Christian Medical College Vellore
Vellore, Tamil Nadu, 632517
Deepti Bal, DM, 9003573111, dr.deeptibal@gmail.com
Deepti Bal, DM
About this study
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.
Read the detailed description
Global Burden of Disease, Injury and Risk factors for hemorrhagic stroke 2010 estimated the burden of spontaneous intracranial haemorrhage (sICH) in India is profound (32 -49%) and it is associated with high mortality (up to 63 %) due to haematoma expansion which occurs in 38% of ICH within first few hours of presentation. Early administration of haemostatic drugs has been used in patients with trauma and was associated with improved outcomes. Similarly, if haemostatic drugs are administered early, which can be a simple and cost-effective intervention, may improve the functional outcomes in patients with sICH. Recently, the Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH 2 trial), which was done to see the effectiveness of the administration of tranexamic acid on hematoma expansion and functional outcomes at three months in patients who presented with sICH within 8 hours of presentation of symptoms onset, showed a decrease in haematoma expansion but no improvement in functional outcome at 90 days. Further larger randomized control trials are required to ascertain the effect of early administration of Tranexamic acid (TXA) in sICH. In India patients present to hospitals in the early stages that have developed symptoms after sICH and we propose to study the effect of intravenous Tranexamic Acid for hyperacute primary intracerebral haemorrhage within 4.5 hours of sICH.
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
- Intracerebral Hemorrhagic Stroke
- Being tested
- Tranexamic acid injection
- Keywords
- Stroke, Spontaneous Intracerebral Haemorrhage, Tranexamic acid
- Medical subject headings
- Hemorrhagic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
Also called Injection Pause 500 mg/5 ml, Injection Cyklokapron 500 mg/5 ml, Injection Trapic 500 mg/5 ml, Injection Tramix 500 mg/5 ml
The treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml sodium chloride 0.9 % administered over 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Drug: Tranexamic acid injection |
| Control Arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death at day 30. Absolute difference of 3% between intervention and control arm for the number of participants that expired at day 30
Measured: 30 days
Secondary outcomes (4)
Change in hematoma volume
Radiological (CT scan): Change in hematoma volume from baseline to 24 hours scan, hematoma location and new infraction
Measured: 24 hours
Neurological impairment
Neurological impairment National Institutes of Health Stroke Scale (NIHSS) at day 7 (or discharge if sooner). Lower NIHSS indicates a good outcome.
Measured: 7 days
modified Rankin Scale (mRS)
Dependency using the seven-level modified Rankin Scale (mRS) at day 90. Good outcome is 0-2 and bad outcome is 3-6. Lower mRS indicated good outcome.
Measured: 90 days
Quality of life EQ-5D
Quality of life EuroQoL-5 dimension (EQ-5D) at day 90. Lover score indicates good outcome
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start30 Aug 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracerebral Hemorrhagic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric, randomized, open-label, clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Medical College and Hospital, Ludhiana, India
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Post Graduate Institute of Medical Education and Research, Chandigarh, St. Stephen's Hospital, Delhi, All India Institute of Medical Sciences, Amrita Institute of Medical Sciences & Research Center, Kasturba Medical College Manipal, India, Institute of Neurosciences Kolkata, Bangur Institute of Neurosciences Kolkata, India, Guwahati Neurological Research Center, Guwahati, India, Baptist Christian Hospital, Tezpur, India, National Institute of Mental Health and Neuro Sciences, India, Jawaharlal Institute of Postgraduate Medical Education & Research, Christian Medical College, Vellore, India, CARE Hospitals Hyderabad, India, Lalitha Super Specialities Hospital Guntur, India, Dr. Ramesh Cardiac and Multispeciality Hospital Guntur, India, Government General Hospital Guntur, India, Fortis Escorts Hospital Jaipur, India, Institute of Medical Sciences of the Banaras Hindu University, India, Atal Institute of Medical Super Specilities, (AIMSS) Chamiana, Shimla, All India Institute of Medical Sciences, Bhubaneswar, KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre Balgaum, India, Guru Gobind Singh Medical College & Hospital, PBM Hospital Bikaner, India, Shree Krishna Hospital Pramukhswami Medical College Anand, India, Apollo Excelcare Hospitals Guwahati, India, Manipal Hospital Bangalore, India, Artemis Hospital Gurgaon, India, Dr. Kamakshi Memorial Hospital Chennai, India, Bharati Vidyapeeth DTU Medical College Pune, India, Aster MIMS Hospital Calicut, India, Holy Spirit Hospital Mumbai, India, Sparsh Superspeciality Hospital Bangalore, India, King George's Medical University, Lucknow, India, Assam Medical College, Dibrugarh, India, KG Hospital and Post Graduate Medical Institute Coimbatore, India, Tirunelveli Medical College, Tirunelveli, India, Santokba Durlabhji Memorial Hospital, Jaipur, India, Tezpur Medical College and Hospital, Assam, India, Baby Memorial Hospital Calicut, India, Institute of Human Behaviour and Allied Sciences Delhi, India, The Calcutta Medical Research Institute, Kolkata, India, Fortis Hospital Mulund Mumbai, India, Government Medical College Trivandrum, India, Ruby Hall Clinic, Pune, India, Manipal Hospital Goa, India
- Responsible party
- Principal investigator, Jeyaraj D Pandian, Christian Medical College and Hospital, Ludhiana, India
- Investigators
- Jeyaraj D Pandian, MD DM, Principal investigator, Christian Medical College and Hospital, Ludhiana, Punjab, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836831
- Sponsor's protocol ID
- INTRINSIC Trial
- Status last verified
- Jan 2026
- First submitted
- 19 Apr 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 29778325Meretoja 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.
PubMed 23981692Pandian 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.
PubMed 39633570
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage
- ClinicalTrials.gov ID
- NCT05836831
- Acronym / sponsor ID
- INTRINSIC Trial
- Conditions
- Intracerebral Hemorrhagic Stroke
- Keywords
- Stroke, Spontaneous Intracerebral Haemorrhage, Tranexamic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,400 participants (estimated)
- Lead sponsor
- Christian Medical College and Hospital, Ludhiana, IndiaUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Post Graduate Institute of Medical Education and Research, Chandigarh, St. Stephen's Hospital, Delhi, All India Institute of Medical Sciences, Amrita Institute of Medical Sciences & Research Center, Kasturba Medical College Manipal, India, Institute of Neurosciences Kolkata, Bangur Institute of Neurosciences Kolkata, India, Guwahati Neurological Research Center, Guwahati, India, Baptist Christian Hospital, Tezpur, India, National Institute of Mental Health and Neuro Sciences, India, Jawaharlal Institute of Postgraduate Medical Education & Research, Christian Medical College, Vellore, India, CARE Hospitals Hyderabad, India, Lalitha Super Specialities Hospital Guntur, India, Dr. Ramesh Cardiac and Multispeciality Hospital Guntur, India, Government General Hospital Guntur, India, Fortis Escorts Hospital Jaipur, India, Institute of Medical Sciences of the Banaras Hindu University, India, Atal Institute of Medical Super Specilities, (AIMSS) Chamiana, Shimla, All India Institute of Medical Sciences, Bhubaneswar, KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre Balgaum, India, Guru Gobind Singh Medical College & Hospital, PBM Hospital Bikaner, India, Shree Krishna Hospital Pramukhswami Medical College Anand, India, Apollo Excelcare Hospitals Guwahati, India, Manipal Hospital Bangalore, India, Artemis Hospital Gurgaon, India, Dr. Kamakshi Memorial Hospital Chennai, India, Bharati Vidyapeeth DTU Medical College Pune, India, Aster MIMS Hospital Calicut, India, Holy Spirit Hospital Mumbai, India, Sparsh Superspeciality Hospital Bangalore, India, King George's Medical University, Lucknow, India, Assam Medical College, Dibrugarh, India, KG Hospital and Post Graduate Medical Institute Coimbatore, India, Tirunelveli Medical College, Tirunelveli, India, Santokba Durlabhji Memorial Hospital, Jaipur, India, Tezpur Medical College and Hospital, Assam, India, Baby Memorial Hospital Calicut, India, Institute of Human Behaviour and Allied Sciences Delhi, India, The Calcutta Medical Research Institute, Kolkata, India, Fortis Hospital Mulund Mumbai, India, Government Medical College Trivandrum, India, Ruby Hall Clinic, Pune, India, Manipal Hospital Goa, India
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Global Burden of Disease, Injury and Risk factors for hemorrhagic stroke 2010 estimated the burden of spontaneous intracranial haemorrhage (sICH) in India is profound (32 -49%) and it is associated with high mortality (up to 63 %) due to haematoma expansion which occurs in 38% of ICH within first few hours of presentation. Early administration of haemostatic drugs has been used in patients with trauma and was associated with improved outcomes. Similarly, if haemostatic drugs are administered early, which can be a simple and cost-effective intervention, may improve the functional outcomes in patients with sICH. Recently, the Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH 2 trial), which was done to see the effectiveness of the administration of tranexamic acid on hematoma expansion and functional outcomes at three months in patients who presented with sICH within 8 hours of presentation of symptoms onset, showed a decrease in haematoma expansion but no improvement in functional outcome at 90 days. Further larger randomized control trials are required to ascertain the effect of early administration of Tranexamic acid (TXA) in sICH. In India patients present to hospitals in the early stages that have developed symptoms after sICH and we propose to study the effect of intravenous Tranexamic Acid for hyperacute primary intracerebral haemorrhage within 4.5 hours of sICH.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multicentric, randomized, open-label, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: Tranexamic acid injectionThe 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 intervention | –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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged more than 18 years, presenting with non- traumatic intracerebral haemorrhage within 4.5 hours of onset of stroke symptoms
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid injectionAlso: Injection Pause 500 mg/5 ml, Injection Cyklokapron 500 mg/5 ml, Injection Trapic 500 mg/5 ml, Injection Tramix 500 mg/5 mlThe treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml sodium chloride 0.9 % administered over 45 minutes. | Drug | Intervention Arm |
Primary outcome
Death
Time frame: 30 days
Death at day 30. Absolute difference of 3% between intervention and control arm for the number of participants that expired at day 30
4 secondary outcomes
Change in hematoma volume
Time frame: 24 hours
Neurological impairment
Time frame: 7 days
modified Rankin Scale (mRS)
Time frame: 90 days
Quality of life EQ-5D
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Background: PubMed 29778325Sprigg 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.
- Background: PubMed 23981692Meretoja 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.
- Derived from this study: PubMed 39633570Pandian 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeyaraj D Pandian, MD DM principal investigator
Christian Medical College and Hospital, Ludhiana, Punjab, India
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid injection in people with Intracerebral Hemorrhagic Stroke, run by Christian Medical College and Hospital, Ludhiana, India at 48 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeyaraj D Pandian, MD DM (9915784750, jeyarajpandian@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05836831, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.