Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage

Summary

This multicenter, pragmatic randomized, open-label clinical trial aims to assess whether Tranexamic Acid improves outcomes in adult patients with spontaneous intracerebral haemorrhage. The participants presenting within 4.5 hours of the onset of symptoms of stroke with intracerebral haemorrhage confirmed on Computed Tomography (CT Scan) will be randomized into two groups in a 1:1 ratio using a central online randomization. The treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml 0.9% sodium chloride administered over 45 minutes. Control arm patients will receive standard of care treatment as per the institutional protocol. In both arms, intensive systolic blood pressure reduction to less than 140 mmHg will be done using antihypertensive medications, which has to be achieved within one hour and will be maintained over next seven days. The choice of antihypertensive drug will depend on the clinician's preference. Both groups will have a repeat CT scan after 24 hours to check for any increase in the haematoma volume. Any deterioration in the neurological status will warrant urgent brain imaging. On day 7, the patient will be assessed for their NIHSS score and mRS score. On day 90, quality of life and the functional outcome will be assessed.

Timeline

Start

2022-08-30

Primary completion

2026-11

Completion

2026-11

Publications

• Background 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.
• Background 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.

Drugs

Indications