Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage

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.

Study Overview

• Status: Recruiting
• Conditions: Intracerebral Hemorrhagic Stroke
• Intervention / Treatment: Drug: Tranexamic acid injection

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 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 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 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 Type: Interventional
• Enrollment (Anticipated): 3400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jeyaraj D Pandian, MD DM; Phone Number: 9915784750; Email: jeyarajpandian@hotmail.com
• Study Contact Backup: Name: Atul Phillips, MD FNB; Phone Number: 9999464983; Email: atulphillips@yahoo.co.in

Study Locations

• India
  • Chandigarh, India, 160012
    • Recruiting
    • Postgraduate Institute for Medical Education and Research
    • Contact: Dheeraj Khurana, MD DM; Phone Number: 7087009695; Email: dherajk@yahoo.com
    • Principal Investigator: Dheeraj Khurana, MD DM
  • Delhi, India, 110054
    • Recruiting
    • St Stephen's Hospital
    • Contact: Gaurav K Mittal, MD DM; Phone Number: 7042877975; Email: drgkmittal@gmail.com
    • Principal Investigator: Gaurav K Mittal, MD DM
  • Andhra Pradesh
    • Guntur, Andhra Pradesh, India, 522001
      • Recruiting
      • Government General Hospital
      • Contact: Sundarachary Nagarjunakonda, MD DM; Phone Number: 9440257675; Email: sundarachary@yahoo.com
      • Principal Investigator: Sundarachary Nagarjunakonda, MD DM
    • Guntur, Andhra Pradesh, India, 522001
      • Recruiting
      • Lalitha Super Specialty Hospital
      • Contact: Vijaya Pamidimukkala, MD DM; Phone Number: 9440808621; Email: drvijayapvr@gmail.com
      • Principal Investigator: Vijaya Pamidimukkala, MD DM
    • Guntur, Andhra Pradesh, India, 522004
      • Recruiting
      • Dr Ramesh Cardiac and Multispecialty Hospital
      • Contact: Somasundaram Kumaravelu, MD DM; Phone Number: 9553651777; Email: neurovelu@gmail.com
      • Principal Investigator: Somasundaram Kumaravelu, MD DM
  • Assam
    • Dibrugarh, Assam, India, 786001
      • Recruiting
      • Assam Medical College
      • Contact: Binod Sarmah, MD DM; Phone Number: 9577631327; Email: b_sarmah2007@yahoo.com
      • Principal Investigator: Binod Sarmah, MD DM
    • Guwahati, Assam, India, 781006
      • Recruiting
      • Guwahati Neurological Research Center
      • Contact: Nomal C Borah, MD DM; Phone Number: 9706050234; Email: ncborah@gnrchospitals.com
      • Principal Investigator: Nomal C Borah, MD DM
    • Guwahati, Assam, India, 781033
      • Recruiting
      • Apollo Excelcare Hospitals
      • Contact: Lakshya J Basumatary, MD DM; Phone Number: 9954480668; Email: drbasumatary@gmail.com
      • Principal Investigator: Lakshya J Basumatary, MD DM
    • Tezpur, Assam, India, 784001
      • Recruiting
      • Baptist Christian Hospital
      • Contact: Jacob Johnson, MD; Phone Number: 7598626847; Email: cooljacky44@gmail.com
      • Principal Investigator: Jacob Johnson, MD
    • Tezpur, Assam, India, 784153
      • Recruiting
      • Tezpur Medical College and Hospital
      • Contact: Dwijen Das, MD; Phone Number: 9435181953; Email: drdwijendas@yahoo.co.in
      • Principal Investigator: Dwijen Das, MD
  • Delhi
    • New Delhi, Delhi, India, 110029
      • Recruiting
      • All India Institute of Medical Sciences
      • Contact: Rohit Bhatia, MD DM; Phone Number: 98912 67417; Email: rohitbhatia71@yahoo.com
      • Principal Investigator: Rohit Bhatia, MD DM
    • New Delhi, Delhi, India, 110095
      • Recruiting
      • Institute of Human Behaviour and Allied Sciences
      • Contact: Rajinder K Dhamija, MD DNB; Phone Number: 99908 86679; Email: director@ihbas.org
      • Principal Investigator: Rajinder K Dhamija, MD DNB
  • Goa
    • Panjim, Goa, India, 403004
      • Not yet recruiting
      • Manipal Hospital
      • Contact: Parul Dubey, MD DM; Phone Number: 9552530337; Email: drdubeyparul@gmail.com
      • Principal Investigator: Parul Dubey, MD DM
  • Gujarat
    • Anand, Gujarat, India, 388325
      • Recruiting
      • Shree Krishna Hospital Pramukhswami Medical College
      • Contact: Soaham Desai, MD DM; Phone Number: 9979937885; Email: drsoahamdesai@yahoo.com
      • Principal Investigator: Soaham Desai, MD DM
  • Haryana
    • Gurgaon, Haryana, India, 122001
      • Recruiting
      • Artemis hospital
      • Contact: Rajsrinivas Parthasarathy, MBBS MRCP; Phone Number: 8826007421; Email: rajsrinivasp@yahoo.co.in
      • Principal Investigator: Rajsrinivas Parthasarathy, MBBS MRCP
  • Himachal Pradesh
    • Bilāspur, Himachal Pradesh, India, 174001
      • Recruiting
      • All India Institute of Medical Sciences
      • Contact: Ashish Sharma, MD DM; Phone Number: 98163 97700; Email: ashishsharmamd@yahoo.co.in
      • Principal Investigator: Ashish Sharma, MD DM
    • Shimla, Himachal Pradesh, India, 171001
      • Recruiting
      • Atal Institute of Medical Super Specilities, (AIMSS) Chamiana
      • Contact: Sudhir Sharma, MD DM; Phone Number: 9418523202; Email: sharmasudhir21@gmail.com
      • Principal Investigator: Sudhir Sharma, MD DM
  • Karnataka
    • Bangalore, Karnataka, India, 560017
      • Not yet recruiting
      • Manipal Hospital
      • Contact: Pramod Krishnan, MD DM; Phone Number: 8971599998; Email: pramod.krishnan@manipalhospitals.com
      • Principal Investigator: Pramod Krishnan, MD DM
    • Bangalore, Karnataka, India, 560022
      • Recruiting
      • Sparsh Superspeciality Hospital
      • Contact: Madhusudhan B Kempegowda, MD DM; Phone Number: 9902078244; Email: drmadhubk@gmail.com
      • Principal Investigator: Madhusudhan B Kempegowda, MD DM
    • Bangalore, Karnataka, India, 560029
      • Not yet recruiting
      • National Institute of Mental Health and Neuro-Sciences
      • Contact: Girish B Kulkarni, MD DM; Phone Number: 9035160614; Email: gbk5000@rediffmail.com
      • Principal Investigator: Girish B Kulkarni, MD DM
    • Belgaum, Karnataka, India, 590010
      • Recruiting
      • KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
      • Contact: Aralikatte O Saroja, MD DM; Phone Number: 9448468474; Email: sarojaao2002@yahoo.com
      • Principal Investigator: Aralikatte O Saroja, MD DM
    • Manipala, Karnataka, India, 576104
      • Recruiting
      • Kasturba Medical College Manipal
      • Contact: Girish Menon, MBBS MCh; Phone Number: 7760563666; Email: girish.menon@manipal.edu
      • Principal Investigator: Girish Menon, MBBS MCh
  • Kerala
    • Calicut, Kerala, India, 673004
      • Recruiting
      • Baby Memorial Hospital
      • Contact: Ummer Karadan, MD DM; Phone Number: 94478 43954; Email: ummerneuro1@gmail.com
      • Principal Investigator: Ummer Karadan, MD DM
    • Calicut, Kerala, India, 673016
      • Recruiting
      • ASTER MIMS Hospital
      • Contact: Paul J Alapatt, DM, PDF; Phone Number: 9447342034; Email: pauljalapatt@gmail.com
      • Principal Investigator: Paul J Alapatt, DM, PDF
    • Kochi, Kerala, India, 682041
      • Recruiting
      • Amrita Institute for Medical Sciences and Research Center
      • Contact: Vivek K Nambiar, MD DM; Phone Number: 8921485541; Email: vivek19602@aims.amrita.edu
      • Principal Investigator: Vivek K Nambiar, MD DM
    • Thiruvananthapuram, Kerala, India, 695011
      • Recruiting
      • Government Medical College Trivandrum
      • Contact: Thomas Iype, MD DM; Phone Number: 94462 30317; Email: drthomasiypeneuro@gmail.com
      • Principal Investigator: Thomas Iype, MD DM
    • Thiruvananthapuram, Kerala, India, 695011
      • Recruiting
      • Sree Chitra Tirunal Institute for Medical Sciences and Technology
      • Contact: Padmavathyamma N Sylaja, MD DM; Phone Number: 9446566287; Email: sylajapn@hotmail.com
      • Principal Investigator: Padmavathyamma N Sylaja, MD DM
  • Maharashtra
    • Mumbai, Maharashtra, India, 400078
      • Recruiting
      • Fortis Hospital Mulund
      • Contact: Rajesh Benny, DNB DM; Phone Number: 9820410322; Email: rajeshbenny@gmail.com
      • Principal Investigator: Rajesh Benny, DNB DM
    • Mumbai, Maharashtra, India, 400093
      • Recruiting
      • Holy Spirit Hospital
      • Contact: Darshan Doshi, MD DM; Phone Number: 9845633469; Email: darshankdoshi@gmail.com
      • Principal Investigator: Darshan Doshi, MD DM
    • Pune, Maharashtra, India, 411001
      • Recruiting
      • Ruby Hall Clinic
      • Contact: Kapil Zirpe, MBBS MD; Phone Number: 9822844212; Email: kapilzirpe@gmail.com
      • Principal Investigator: Kapil Zirpe, MBBS MD
    • Pune, Maharashtra, India, 411043
      • Recruiting
      • Bharati Vidyapeeth DTU Medical College
      • Contact: Sankar P Gorthi, MD DM; Phone Number: 8800233991; Email: pgorthi2002@yahoo.com
      • Principal Investigator: Sankar P Gorthi, MD DM
  • Orissa
    • Bhubaneswar, Orissa, India, 751019
      • Recruiting
      • All India Institute of Medical Sciences
      • Contact: Sanjeev K Bhoi, DM,PDF; Phone Number: 9919787978; Email: neuro_sanjeev@aiimsbhubaneswar.edu.in
      • Principal Investigator: Sanjeev K Bhoi, DM,PDF
  • Punjab
    • Farīdkot, Punjab, India, 151203
      • Recruiting
      • Guru Gobind Singh Medical College and Hospital
      • Contact: Sulena Sulena, MD DM; Phone Number: 7087907025; Email: sulenasingh@yahoo.co.in
      • Principal Investigator: Sulena Sulena, MD DM
    • Ludhiāna, Punjab, India, 141008
      • Recruiting
      • Christian Medical College and Hospital, Ludhiana, Punjab
      • Contact: Jeyaraj D Pandian, MD DM; Phone Number: 9915784750; Email: jeyarajpandian@hotmail.com
      • Principal Investigator: Jeyaraj D Pandian, MD DM
  • Rajasthan
    • Bīkaner, Rajasthan, India, 334001
      • Recruiting
      • PBM Hospital
      • Contact: Inder Puri, MD DM; Phone Number: 7023266560; Email: dr.inderpuri@gmail.com
      • Principal Investigator: Inder Puri, MD DM
    • Jaipur, Rajasthan, India, 302017
      • Recruiting
      • Fortis Escorts Hospital
      • Contact: Neetu Ramrakhiani, MD DM DNB; Phone Number: 9314932648; Email: neetudilip@yahoo.co.in
      • Principal Investigator: Neetu Ramrakhiani, MD DM DNB
    • Jaipur, Rajasthan, India, 302015
      • Recruiting
      • Santokba Durlabhji Memorial Hospital
      • Contact: Neeraj Bhutani, DM; Phone Number: 98287 11808; Email: drneerajbhutani@rediffmail.com
      • Principal Investigator: Neeraj Bhutani, DM
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600100
      • Recruiting
      • Dr. Kamakshi Memorial Hospital
      • Contact: Parveen Chander, MD DM; Phone Number: 9444472722; Email: drnpcmd@gmail.com
      • Principal Investigator: Parveen Chander, MD DM
    • Coimbatore, Tamil Nadu, India, 641018
      • Recruiting
      • KG Hospital and Post Graduate Medical Institute Coimbatore
      • Contact: TCR Ramakrishnan, MD DM; Phone Number: 9443365792; Email: kgneuro@gmail.com
      • Principal Investigator: TCR Ramakrishnan, MD DM
    • Puducherry, Tamil Nadu, India, 605006
      • Recruiting
      • Jawaharlal Institute Of Postgraduate Medical Education And Research
      • Contact: Sunil K Narayan, DM, PhD; Phone Number: 9443617120; Email: sknarayan@gmail.com
      • Principal Investigator: Sunil K Narayan, DM, PhD
    • Tirunelveli, Tamil Nadu, India, 627011
      • Recruiting
      • Tirunelveli Medical College
      • Contact: S Saravanan, MD DM; Phone Number: 9842909451; Email: drsaravananneuro@gmail.com
      • Principal Investigator: S Saravanan, MD DM
    • Vellore, Tamil Nadu, India, 632517
      • Recruiting
      • Christian Medical College Vellore
      • Contact: Deepti Bal, DM; Phone Number: 9003573111; Email: dr.deeptibal@gmail.com
      • Principal Investigator: Deepti Bal, DM
  • Telangana
    • Hyderabad, Telangana, India, Hyderabad
      • Recruiting
      • Care Hospitals
      • Contact: Yerasu M Reddy, DM DNB; Phone Number: 9912329342; Email: muralidharnims@gmail.com
      • Principal Investigator: Yerasu M Reddy, DM DNB
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226003
      • Recruiting
      • King George's Medical University
      • Contact: Parveen K Sharma, MD DM; Phone Number: 7388111289; Email: pspgimer@gmail.com
      • Principal Investigator: Parveen K Sharma, MD DM
    • Varanasi, Uttar Pradesh, India, 221005
      • Recruiting
      • Institute of Medical Sciences of the Banaras Hindu University (BHU)
      • Contact: Abhishek Pathak, MD DM; Phone Number: 8948512666; Email: abhishekpathakaiims@gmail.com
      • Principal Investigator: Abhishek Pathak, MD DM
  • West Bengal
    • Kolkata, West Bengal, India, 700017
      • Recruiting
      • Institute of Neurosciences
      • Contact: Jayanta Roy, MD DM; Phone Number: 9903048154; Email: jroyneuro01@gmail.com
      • Principal Investigator: Jayanta Roy, MD DM
    • Kolkata, West Bengal, India, 700020
      • Recruiting
      • Bangur Institute of Neurosciences
      • Contact: Biman K Ray, MD DM; Phone Number: 9433185327; Email: biman.kanti@rediffmail.com
      • Principal Investigator: Biman K Ray, MD DM
    • Kolkata, West Bengal, India, 700027
      • Recruiting
      • The Calcutta Medical Research Center
      • Contact: Sujoy Mukherjee, MD FNB; Phone Number: 9330960230; Email: drsujoym@gmail.com
      • Principal Investigator: Sujoy Mukherjee, MD FNB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with intracerebral haemorrhage secondary to anticoagulation, thrombolysis, known underlying structural abnormality such as arteriovenous malformation, aneurysm, tumour or venous thrombosis or due to known hereditary coagulation disorders. An underlying structural abnormality does not need to be excluded before enrolment, but where known, patients should not be recruited.
2. Known allergies to Tranexamic Acid.
3. Premorbid modified Rankin scale score >4 at the time of enrollment.
4. Concurrent participation in another drug or device trial.
5. Pre stroke life expectancy <3 months (e.g. advanced metastatic cancer).
6. Glasgow coma scale <7.
7. ICH secondary to trauma.
8. Women pregnant, or breastfeeding at randomization.
9. Planned surgery for ICH within 24 hours.
10. Concurrent or planned treatment with any other haemostatic agents.
11. ICH volume > 60 ml as measured by the ABC/2 method on CT Scan

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; The treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml sodium chloride 0.9 % adminsitered 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 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.	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.; Other Names: Injection Pause 500 mg/5 ml; Injection Cyklokapron 500 mg/5 ml; Injection Trapic 500 mg/5 ml; Injection Tramix 500 mg/5 ml
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death at day 7	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hematoma volume	Radiological (CT scan): Change in hematoma volume from baseline to 24 hours scan, hematoma location and new infraction	24 hours
Neurological impairment	Neurological impairment (NIHSS) at day 7 (or discharge if sooner)	7 days
modified Rankin Scale (mRS)	Dependency using the seven-level modified Rankin Scale (mRS) at day 90	90 days
Quality of life EQ-5D	Quality of life (EQ-5D) at day 90	90 days

Collaborators and Investigators

• Sponsor: Christian Medical College and Hospital, Ludhiana, India
• Collaborators: All India Institute of Medical Sciences, New Delhi; Indian Council of Medical Research; King George's Medical University; All India Institute of Medical Sciences, Bhubaneswar; Christian Medical College, Vellore, India; National Institute of Mental Health and Neuro Sciences, India; Jawaharlal Institute of Postgraduate Medical Education & Research; Postgraduate Institute of Medical Education and Research, Chandigarh; Amrita Institute of Medical Sciences & Research Center; Sree Chitra Tirunal Institute for Medical Sciences & Technology; Institute of Medical Sciences of the Banaras Hindu University (BHU),India; Assam Medical College; St. Stephen's Hospital, Delhi; 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; 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; Atal Institute of Medical Super Specilities, (AIMSS) Chamiana, Shimla; 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; All India Institute of Medical Sciences, Bilaspur, India; KG Hospital and Post Graduate Medical Institute Coimbatore, India; Tirunelveli Medical College, Tirunelveli, India; Santokba Durlabhji Memorial Hospital; 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; Fortis Hospital Mulund Mumbai, India; Government Medical College Trivandrum, India; Ruby Hall Clinic, Pune, India; Manipal Hospital Goa, India
• Investigators: Principal Investigator: Jeyaraj D Pandian, MD DM, Christian Medical College and Hospital, Ludhiana, Punjab, India

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Tranexamic acid; Spontaneous Intracerebral Haemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Hemorrhagic Stroke; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: INTRINSIC Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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. 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No