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.
Author(s): Meretoja A(1), 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.
Affiliation(s): Author information:
(1)Department of Medicine, University of Melbourne, Parkville, Victoria,
Australia; Department of Neurology, The Royal Melbourne Hospital, Parkville,
Victoria, Australia; The Florey Institute of Neuroscience and Mental Health,
Parkville, Victoria, Australia; Department of Neurology, Helsinki University
Central Hospital, Helsinki, Finland.
Publication date & source: 2014, Int J Stroke. , 9(4):519-24
RATIONALE: 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 <70 ml, no identified secondary cause
of intracerebral hemorrhage, no thrombotic events within the previous 12 months,
no planned surgery) and demonstrating contrast extravasation on computed
tomography angiography will receive either intravenous tranexamic acid 1 g 10-min
bolus followed by 1 g eight-hour infusion or placebo. A second computed
tomography will be performed at 24 ± 3 hours to evaluate intracerebral hemorrhage
growth and patients followed up for three-months.
STUDY OUTCOMES: The primary outcome measure is presence of intracerebral
hemorrhage growth by 24 ± 3 hours, defined as either >33% or >6 ml 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.
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