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

Atte Meretoja, Leonid Churilov, Bruce Charles Vivian Campbell, Richard I Aviv, Nawaf Yassi, Christen David James Barras, Peter J Mitchell, Bernard Yan, Harshal Hanumant Nandurkar, Christopher F Bladin, Tissa Wijeratne, Neil Spratt, Jim Jannes, Jonathan W Sturm, Jayantha Rupasinghe, Jorge A Zavala, Andrew Lee, Timothy John Kleinig, Romesh Markus, Candice DelcourtNeil Mahant, Mark W Parsons, Christopher Royce Levi, Craig S Anderson, Geoffrey Donnan, Stephen M Davis

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Abstract

No evidence-based acute therapies exist for intracerebral hemorrhage. Intracerebral hemorrhage growth is an important determinant of patient outcome. Tranexamic acid is known to reduce hemorrhage in other conditions. Aim: The study aims to test the hypothesis that intracerebral hemorrhage patients selected with computed tomography angiography contrast extravasation spot sign will have lower rates of hematoma growth when treated with intravenous tranexamic acid within 4?5-hours of stroke onset compared with placebo. Design: The Spot sign and Tranexamic acid On Preventing ICH growth - AUStralasia Trial is a multicenter, prospective, 1:1 randomized, double-blind, placebo-controlled, investigator-initiated, academic Phase II trial. Intracerebral hemorrhage patients fulfilling clinical criteria (e.g. Glasgow Coma Scale >7, intracerebral hemorrhage volume 33 or >6ml increase from baseline, and will be adjusted for baseline intracerebral hemorrhage volume. Secondary outcome measures include growth as a continuous measure, thromboembolic events, and the three-month modified Rankin Scale score. Discussion: This is the first trial to evaluate the efficacy of tranexamic acid in intracerebral hemorrhage patients selected based on an imaging biomarker of high likelihood of hematoma growth. The trial is registered as NCT01702636.
Original languageEnglish
Pages (from-to)519 - 524
Number of pages6
JournalInternational Journal of Stroke
Volume9
Issue number4
DOIs
Publication statusPublished - 2014

Cite this

Meretoja, A., Churilov, L., Campbell, B. C. V., Aviv, R. I., Yassi, N., Barras, C. D. J., Mitchell, P. J., Yan, B., Nandurkar, H. H., Bladin, C. F., Wijeratne, T., Spratt, N., Jannes, J., Sturm, J. W., Rupasinghe, J., Zavala, J. A., Lee, A., Kleinig, T. J., Markus, R., ... Davis, S. M. (2014). 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. International Journal of Stroke, 9(4), 519 - 524. https://doi.org/10.1111/ijs.12132