Indian Trial of Tranexamic acid in Spontaneous Intracerebral Hemorrhage study protocol

Jeyaraj Durai Pandian; Atul Phillips; Shweta Jain Verma; Deepti Arora; Aneesh Dhasan; Pheba S. Raju; P. N. Sylaja; Biman Kanti Ray; Uddalak Chakraborty; Jacob Johnson; Praveen Kumar Sharma; Sanjeev Bhoi; Menka Jha; Thomas Iype; P. Chithra; Dheeraj Khurana; Sucharita Ray; Dwijen Das; Naurima Kalita; Sweekriti Adhikari; Ashish Sharma; Jayanta Roy; Rajeshwar Sahonta; Sulena Singh; Vikram Chaudhary; Girish Menon; Sanjith Aaron; Deepti Bal; Rajinder K. Dhamija; Monali Chaturvedi; Siddarth Maheshwari; Aralikatte Onkarappa Saroja; Karkal R. Naik; Neeraj Bhutani; Kailash Dhankhar; Dinesh Sharma; Rohit Bhatia; Sankar Prasad Gorthi; Binod Sarmah; Vijaya Pamidimukkala; Sankaralingam Saravanan; Sunil Narayan; Lakshya J. Basumatary; Nagarjunakonda V. Sundarachary; Aruna K. Upputuri; Ummer Karadan; V. G. Pradeep Kumar; Rajsrinivas Parthasarathy; Darshan Doshi; Satish Wagh; T. C.R. Ramakrishnan; Saleem Akhtar; Soaham Desai; N. C. Borah; Rupjyoti Das; Gaurav Mittal; Agam Jain; Paul J. Alapatt; Girish Baburao Kulkarni; Deepak Menon; Pritam Raja; Inder Puri; Vivek Nambiar; Muralidhar Reddy Yerasu; Shyam K. Jaiswal; Kapil Zirpe; Sushma Gurav; Sudheer Sharma; S. Kumaravelu; Rajesh Benny; Vicky Thakkar; Abhishek Pathak; Madhusudhan Kempegowda; Praveen Chander; Neetu Ramrakhiani; Arya Devi KS; P. Sankara Sarma; Rahul Huilgol; Meenakshi Sharma; Rupinder S. Dhaliwal

doi:10.1177/17474930241307933

Indian Trial of Tranexamic acid in Spontaneous Intracerebral Hemorrhage study protocol

Jeyaraj Durai Pandian^*, Atul Phillips, Shweta Jain Verma, Deepti Arora, Aneesh Dhasan, Pheba S. Raju, P. N. Sylaja, Biman Kanti Ray, Uddalak Chakraborty, Jacob Johnson, Praveen Kumar Sharma, Sanjeev Bhoi, Menka Jha, Thomas Iype, P. Chithra, Dheeraj Khurana, Sucharita Ray, Dwijen Das, Naurima Kalita, Sweekriti AdhikariAshish Sharma, Jayanta Roy, Rajeshwar Sahonta, Sulena Singh, Vikram Chaudhary, Girish Menon, Sanjith Aaron, Deepti Bal, Rajinder K. Dhamija, Monali Chaturvedi, Siddarth Maheshwari, Aralikatte Onkarappa Saroja, Karkal R. Naik, Neeraj Bhutani, Kailash Dhankhar, Dinesh Sharma, Rohit Bhatia, Sankar Prasad Gorthi, Binod Sarmah, Vijaya Pamidimukkala, Sankaralingam Saravanan, Sunil Narayan, Lakshya J. Basumatary, Nagarjunakonda V. Sundarachary, Aruna K. Upputuri, Ummer Karadan, V. G. Pradeep Kumar, Rajsrinivas Parthasarathy, Darshan Doshi, Satish Wagh, T. C.R. Ramakrishnan, Saleem Akhtar, Soaham Desai, N. C. Borah, Rupjyoti Das, Gaurav Mittal, Agam Jain, Paul J. Alapatt, Girish Baburao Kulkarni, Deepak Menon, Pritam Raja, Inder Puri, Vivek Nambiar, Muralidhar Reddy Yerasu, Shyam K. Jaiswal, Kapil Zirpe, Sushma Gurav, Sudheer Sharma, S. Kumaravelu, Rajesh Benny, Vicky Thakkar, Abhishek Pathak, Madhusudhan Kempegowda, Praveen Chander, Neetu Ramrakhiani, Arya Devi KS, P. Sankara Sarma, Rahul Huilgol, Meenakshi Sharma, Rupinder S. Dhaliwal

^*Corresponding author for this work

Department of Neurosurgery, Kasturba Medical College, Manipal

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

Abstract

Rationale: Early mortality in intracerebral hemorrhage (ICH) is due to hematoma volume (HV) expansion, and there are no effective treatments available other than reduction in blood pressure. Tranexamic acid (TXA) a hemostatic drug that is widely available and safe can be a cost-effective treatment for ICH, if proven efficacious. Hypothesis: Administration of TXA in ICH patients when given within 4.5 h of symptom onset will reduce early mortality at 30 days. Design: Indian Trial of Tranexamic acid in Spontaneous Intracerebral Haemorrhage (INTRINSIC trial) is a multicenter, randomized, open-label, trial enrolling patients aged more than 18 years presenting with non-traumatic ICH within 4.5 h of symptom onset or when last seen well. Study participants received 2 g of TXA administered within 45 min while control group received standard of care. Intensive blood pressure reduction as per INTERACT 2 protocol is followed is done in both groups. Study plans to recruit 3400 patients. Primary outcome is mortality at day 30. Secondary outcomes are radiological reduction in HV at 24 h from baseline, neurological impairment at day 7 or earlier (if discharged), and assessments of dependency and quality of life at day 90. Summary: If proven to be beneficial, TXA will have a major impact on medical management of ICH. Trial registration: Clinical Trial Registry India (CTRI/2023/03/050224) and Clinical Trials.gov (NCT05836831).

Original language	English
Pages (from-to)	756-762
Number of pages	7
Journal	International Journal of Stroke
Volume	20
Issue number	6
DOIs	https://doi.org/10.1177/17474930241307933
Publication status	Published - 07-2025

All Science Journal Classification (ASJC) codes

Neurology
Clinical Neurology

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10.1177/17474930241307933

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Pandian, J. D., Phillips, A., Verma, S. J., Arora, D., Dhasan, A., Raju, P. S., Sylaja, P. N., Ray, B. K., Chakraborty, U., Johnson, J., Sharma, P. K., Bhoi, S., Jha, M., Iype, T., Chithra, P., Khurana, D., Ray, S., Das, D., Kalita, N., ... Dhaliwal, R. S. (2025). Indian Trial of Tranexamic acid in Spontaneous Intracerebral Hemorrhage study protocol. International Journal of Stroke, 20(6), 756-762. https://doi.org/10.1177/17474930241307933

@article{0cbd44d7b0244639aacbe87a9ed4cebf,

title = "Indian Trial of Tranexamic acid in Spontaneous Intracerebral Hemorrhage study protocol",

abstract = "Rationale: Early mortality in intracerebral hemorrhage (ICH) is due to hematoma volume (HV) expansion, and there are no effective treatments available other than reduction in blood pressure. Tranexamic acid (TXA) a hemostatic drug that is widely available and safe can be a cost-effective treatment for ICH, if proven efficacious. Hypothesis: Administration of TXA in ICH patients when given within 4.5 h of symptom onset will reduce early mortality at 30 days. Design: Indian Trial of Tranexamic acid in Spontaneous Intracerebral Haemorrhage (INTRINSIC trial) is a multicenter, randomized, open-label, trial enrolling patients aged more than 18 years presenting with non-traumatic ICH within 4.5 h of symptom onset or when last seen well. Study participants received 2 g of TXA administered within 45 min while control group received standard of care. Intensive blood pressure reduction as per INTERACT 2 protocol is followed is done in both groups. Study plans to recruit 3400 patients. Primary outcome is mortality at day 30. Secondary outcomes are radiological reduction in HV at 24 h from baseline, neurological impairment at day 7 or earlier (if discharged), and assessments of dependency and quality of life at day 90. Summary: If proven to be beneficial, TXA will have a major impact on medical management of ICH. Trial registration: Clinical Trial Registry India (CTRI/2023/03/050224) and Clinical Trials.gov (NCT05836831).",

author = "Pandian, \{Jeyaraj Durai\} and Atul Phillips and Verma, \{Shweta Jain\} and Deepti Arora and Aneesh Dhasan and Raju, \{Pheba S.\} and Sylaja, \{P. N.\} and Ray, \{Biman Kanti\} and Uddalak Chakraborty and Jacob Johnson and Sharma, \{Praveen Kumar\} and Sanjeev Bhoi and Menka Jha and Thomas Iype and P. Chithra and Dheeraj Khurana and Sucharita Ray and Dwijen Das and Naurima Kalita and Sweekriti Adhikari and Ashish Sharma and Jayanta Roy and Rajeshwar Sahonta and Sulena Singh and Vikram Chaudhary and Girish Menon and Sanjith Aaron and Deepti Bal and Dhamija, \{Rajinder K.\} and Monali Chaturvedi and Siddarth Maheshwari and Saroja, \{Aralikatte Onkarappa\} and Naik, \{Karkal R.\} and Neeraj Bhutani and Kailash Dhankhar and Dinesh Sharma and Rohit Bhatia and Gorthi, \{Sankar Prasad\} and Binod Sarmah and Vijaya Pamidimukkala and Sankaralingam Saravanan and Sunil Narayan and Basumatary, \{Lakshya J.\} and Sundarachary, \{Nagarjunakonda V.\} and Upputuri, \{Aruna K.\} and Ummer Karadan and \{Pradeep Kumar\}, \{V. G.\} and Rajsrinivas Parthasarathy and Darshan Doshi and Satish Wagh and Ramakrishnan, \{T. C.R.\} and Saleem Akhtar and Soaham Desai and Borah, \{N. C.\} and Rupjyoti Das and Gaurav Mittal and Agam Jain and Alapatt, \{Paul J.\} and Kulkarni, \{Girish Baburao\} and Deepak Menon and Pritam Raja and Inder Puri and Vivek Nambiar and Yerasu, \{Muralidhar Reddy\} and Jaiswal, \{Shyam K.\} and Kapil Zirpe and Sushma Gurav and Sudheer Sharma and S. Kumaravelu and Rajesh Benny and Vicky Thakkar and Abhishek Pathak and Madhusudhan Kempegowda and Praveen Chander and Neetu Ramrakhiani and KS, \{Arya Devi\} and Sarma, \{P. Sankara\} and Rahul Huilgol and Meenakshi Sharma and Dhaliwal, \{Rupinder S.\}",

note = "Publisher Copyright: {\textcopyright} 2025 World Stroke Organization.",

year = "2025",

month = jul,

doi = "10.1177/17474930241307933",

language = "English",

volume = "20",

pages = "756--762",

journal = "International Journal of Stroke",

issn = "1747-4930",

publisher = "SAGE Publications Ltd",

number = "6",

}

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, Chithra, P, 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, TCR, 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 2025, 'Indian Trial of Tranexamic acid in Spontaneous Intracerebral Hemorrhage study protocol', International Journal of Stroke, vol. 20, no. 6, pp. 756-762. https://doi.org/10.1177/17474930241307933

TY - JOUR

T1 - Indian Trial of Tranexamic acid in Spontaneous Intracerebral Hemorrhage study protocol

AU - Pandian, Jeyaraj Durai

AU - Phillips, Atul

AU - Verma, Shweta Jain

AU - Arora, Deepti

AU - Dhasan, Aneesh

AU - Raju, Pheba S.

AU - Sylaja, P. N.

AU - Ray, Biman Kanti

AU - Chakraborty, Uddalak

AU - Johnson, Jacob

AU - Sharma, Praveen Kumar

AU - Bhoi, Sanjeev

AU - Jha, Menka

AU - Iype, Thomas

AU - Chithra, P.

AU - Khurana, Dheeraj

AU - Ray, Sucharita

AU - Das, Dwijen

AU - Kalita, Naurima

AU - Adhikari, Sweekriti

AU - Sharma, Ashish

AU - Roy, Jayanta

AU - Sahonta, Rajeshwar

AU - Singh, Sulena

AU - Chaudhary, Vikram

AU - Menon, Girish

AU - Aaron, Sanjith

AU - Bal, Deepti

AU - Dhamija, Rajinder K.

AU - Chaturvedi, Monali

AU - Maheshwari, Siddarth

AU - Saroja, Aralikatte Onkarappa

AU - Naik, Karkal R.

AU - Bhutani, Neeraj

AU - Dhankhar, Kailash

AU - Sharma, Dinesh

AU - Bhatia, Rohit

AU - Gorthi, Sankar Prasad

AU - Sarmah, Binod

AU - Pamidimukkala, Vijaya

AU - Saravanan, Sankaralingam

AU - Narayan, Sunil

AU - Basumatary, Lakshya J.

AU - Sundarachary, Nagarjunakonda V.

AU - Upputuri, Aruna K.

AU - Karadan, Ummer

AU - Pradeep Kumar, V. G.

AU - Parthasarathy, Rajsrinivas

AU - Doshi, Darshan

AU - Wagh, Satish

AU - Ramakrishnan, T. C.R.

AU - Akhtar, Saleem

AU - Desai, Soaham

AU - Borah, N. C.

AU - Das, Rupjyoti

AU - Mittal, Gaurav

AU - Jain, Agam

AU - Alapatt, Paul J.

AU - Kulkarni, Girish Baburao

AU - Menon, Deepak

AU - Raja, Pritam

AU - Puri, Inder

AU - Nambiar, Vivek

AU - Yerasu, Muralidhar Reddy

AU - Jaiswal, Shyam K.

AU - Zirpe, Kapil

AU - Gurav, Sushma

AU - Sharma, Sudheer

AU - Kumaravelu, S.

AU - Benny, Rajesh

AU - Thakkar, Vicky

AU - Pathak, Abhishek

AU - Kempegowda, Madhusudhan

AU - Chander, Praveen

AU - Ramrakhiani, Neetu

AU - KS, Arya Devi

AU - Sarma, P. Sankara

AU - Huilgol, Rahul

AU - Sharma, Meenakshi

AU - Dhaliwal, Rupinder S.

PY - 2025/7

Y1 - 2025/7

N2 - Rationale: Early mortality in intracerebral hemorrhage (ICH) is due to hematoma volume (HV) expansion, and there are no effective treatments available other than reduction in blood pressure. Tranexamic acid (TXA) a hemostatic drug that is widely available and safe can be a cost-effective treatment for ICH, if proven efficacious. Hypothesis: Administration of TXA in ICH patients when given within 4.5 h of symptom onset will reduce early mortality at 30 days. Design: Indian Trial of Tranexamic acid in Spontaneous Intracerebral Haemorrhage (INTRINSIC trial) is a multicenter, randomized, open-label, trial enrolling patients aged more than 18 years presenting with non-traumatic ICH within 4.5 h of symptom onset or when last seen well. Study participants received 2 g of TXA administered within 45 min while control group received standard of care. Intensive blood pressure reduction as per INTERACT 2 protocol is followed is done in both groups. Study plans to recruit 3400 patients. Primary outcome is mortality at day 30. Secondary outcomes are radiological reduction in HV at 24 h from baseline, neurological impairment at day 7 or earlier (if discharged), and assessments of dependency and quality of life at day 90. Summary: If proven to be beneficial, TXA will have a major impact on medical management of ICH. Trial registration: Clinical Trial Registry India (CTRI/2023/03/050224) and Clinical Trials.gov (NCT05836831).

AB - Rationale: Early mortality in intracerebral hemorrhage (ICH) is due to hematoma volume (HV) expansion, and there are no effective treatments available other than reduction in blood pressure. Tranexamic acid (TXA) a hemostatic drug that is widely available and safe can be a cost-effective treatment for ICH, if proven efficacious. Hypothesis: Administration of TXA in ICH patients when given within 4.5 h of symptom onset will reduce early mortality at 30 days. Design: Indian Trial of Tranexamic acid in Spontaneous Intracerebral Haemorrhage (INTRINSIC trial) is a multicenter, randomized, open-label, trial enrolling patients aged more than 18 years presenting with non-traumatic ICH within 4.5 h of symptom onset or when last seen well. Study participants received 2 g of TXA administered within 45 min while control group received standard of care. Intensive blood pressure reduction as per INTERACT 2 protocol is followed is done in both groups. Study plans to recruit 3400 patients. Primary outcome is mortality at day 30. Secondary outcomes are radiological reduction in HV at 24 h from baseline, neurological impairment at day 7 or earlier (if discharged), and assessments of dependency and quality of life at day 90. Summary: If proven to be beneficial, TXA will have a major impact on medical management of ICH. Trial registration: Clinical Trial Registry India (CTRI/2023/03/050224) and Clinical Trials.gov (NCT05836831).

UR - https://www.scopus.com/pages/publications/85214098758

UR - https://www.scopus.com/inward/citedby.url?scp=85214098758&partnerID=8YFLogxK

U2 - 10.1177/17474930241307933

DO - 10.1177/17474930241307933

M3 - Article

C2 - 39633570

AN - SCOPUS:85214098758

SN - 1747-4930

VL - 20

SP - 756

EP - 762

JO - International Journal of Stroke

JF - International Journal of Stroke

IS - 6

ER -

Indian Trial of Tranexamic acid in Spontaneous Intracerebral Hemorrhage study protocol

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