Tranexamic acid for spontaneous intracerebral hemorrhage: a randomized controlled
pilot trial (ISRCTN50867461).
Author(s): Sprigg N(1), Renton CJ(2), Dineen RA(2), Kwong Y(3), Bath PM(2).
Affiliation(s): Author information:
(1)Stroke Trials Unit, Division of Clinical Neurosciences, School of Medicine,
University of Nottingham, Nottingham, UK. Electronic address:
nikola.sprigg@nottingham.ac.uk. (2)Stroke Trials Unit, Division of Clinical
Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK.
(3)Department of Radiology, Nottingham University Hospitals NHS Trust,
Nottingham, UK.
Publication date & source: 2014, J Stroke Cerebrovasc Dis. , 23(6):1312-8
BACKGROUND: Spontaneous intracerebral hemorrhage (ICH) can be devastating,
particularly if hematoma expansion (HE) occurs. Tranexamic acid (TA), an
antifibrinolytic drug, significantly reduced mortality in bleeding patients after
trauma in the large CRASH-2 trial. The CRASH-2 ICH substudy found that TA
nonsignificantly reduced mortality and dependency in traumatic ICH. The aim of
this study was to assess the feasibility of performing a randomized controlled
trial of tranexamic acid in spontaneous ICH, ahead of a definitive study.
METHODS: We performed a single-center, prospective, randomized (2:1),
double-blind, placebo-controlled blinded endpoint trial of TA (intravenous 1 g
bolus, 1 g infusion/8 h) in acute (<24 hours) spontaneous ICH. The primary
objective was to test the feasibility of recruiting to the trial. Other
objectives included tolerability (adverse events) and the effect of TA on HE and
death and dependency.
RESULTS: The trial was feasible, with 24 patients enrolled (TA, n=16; placebo,
n=8) between March 2011 and March 2012, and acceptable-only 3 patients declined
to participate. All patients received the correct randomized treatment; 1 patient
in the TA group did not complete the infusion because of neurologic
deterioration. There were no significant differences in secondary outcomes
including adverse events, HE, death, and dependency. One patient in the TA group
had a deep vein thrombosis .
CONCLUSIONS: This, the first randomized controlled trial of TA in ICH, found that
the protocol could be delivered on schedule (2 patients/mo) and was feasible.
Larger studies are needed to assess safety and efficacy of TA in ICH.
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