TY - JOUR
T1 - 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
AU - Meretoja, Atte
AU - Churilov, Leonid
AU - Campbell, Bruce Charles Vivian
AU - Aviv, Richard I
AU - Yassi, Nawaf
AU - Barras, Christen David James
AU - Mitchell, Peter J
AU - Yan, Bernard
AU - Nandurkar, Harshal Hanumant
AU - Bladin, Christopher F
AU - Wijeratne, Tissa
AU - Spratt, Neil
AU - Jannes, Jim
AU - Sturm, Jonathan W
AU - Rupasinghe, Jayantha
AU - Zavala, Jorge A
AU - Lee, Andrew
AU - Kleinig, Timothy John
AU - Markus, Romesh
AU - Delcourt, Candice
AU - Mahant, Neil
AU - Parsons, Mark W
AU - Levi, Christopher Royce
AU - Anderson, Craig S
AU - Donnan, Geoffrey
AU - Davis, Stephen M
PY - 2014
Y1 - 2014
N2 - 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.
AB - 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.
UR - http://onlinelibrary.wiley.com.ezproxy.lib.monash.edu.au/doi/10.1111/ijs.12132/abstract;jsessionid=1B1F4526BA78AC6A4BB287231819834B.f02t01
U2 - 10.1111/ijs.12132
DO - 10.1111/ijs.12132
M3 - Article
SN - 1747-4930
VL - 9
SP - 519
EP - 524
JO - International Journal of Stroke
JF - International Journal of Stroke
IS - 4
ER -