Prehospital transdermal glyceryl trinitrate for ultra-acute intracerebral hemorrhage

Bath, Philip M., Woodhouse, Lisa J., Krishnan, Kailash, Appleton, Jason P., Anderson, Craig S., Berge, Eivind, Cala, Lesley, Dixon, Mark, England, Timothy J., Godolphin, Peter J., Hepburn, Trish, Mair, Grant, Montgomery, Alan A., Phillips, Stephen J., Potter, John, Price, Chris I., Randall, Marc, Robinson, Thompson G., Roffe, Christine, Rothwell, Peter M., Sandset, Else C., Sanossian, Nerses, Saver, Jeffrey L., Siriwardena, A. Niroshan, Venables, Graham, Wardlaw, Joanna M. and Sprigg, Nikola (2019) Prehospital transdermal glyceryl trinitrate for ultra-acute intracerebral hemorrhage. Stroke: a Journal of Cerebral Circulation . ISSN 0039-2499

Full content URL: http://doi.org/10.1161/STROKEAHA.119.026389

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Prehospital Transdermal Glyceryl Trinitrate for Ultra-Acute Intracerebral Hemorrhage Data From the RIGHT-2 Trial
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Abstract

Background and Purpose—Pilot trials suggest that glyceryl trinitrate (GTN; nitroglycerin) may improve outcome when
administered early after stroke onset.
Methods—We undertook a multicentre, paramedic-delivered, ambulance-based, prospective randomized, sham-controlled,
blinded-end point trial in adults with presumed stroke within 4 hours of ictus. Participants received transdermal GTN
(5 mg) or a sham dressing (1:1) in the ambulance and then daily for three days in hospital. The primary outcome
was the 7-level modified Rankin Scale at 90 days assessed by central telephone treatment-blinded follow-up. This
prespecified subgroup analysis focuses on participants with an intracerebral hemorrhage as their index event. Analyses
are intention-to-treat.
Results—Of 1149 participants with presumed stroke, 145 (13%; GTN, 74; sham, 71) had an intracerebral hemorrhage:
time from onset to randomization median, 74 minutes (interquartile range, 45–110). By admission to hospital, blood
pressure tended to be lower with GTN as compared with sham: mean, 4.4/3.5 mmHg. The modified Rankin Scale score
at 90 days was nonsignificantly higher in the GTN group: adjusted common odds ratio for poor outcome, 1.87 (95%
CI, 0.98–3.57). A prespecified global analysis of 5 clinical outcomes (dependency, disability, cognition, quality of life,
and mood) was worse with GTN; Mann-Whitney difference, 0.18 (95% CI, 0.01–0.35; Wei-Lachin test). GTN was
associated with larger hematoma and growth, and more mass effect and midline shift on neuroimaging, and altered use
of hospital resources. Death in hospital but not at day 90 was increased with GTN. There were no significant betweengroup differences in serious adverse events.
Conclusions—Prehospital treatment with GTN worsened outcomes in patients with intracerebral hemorrhage. Since these
results could relate to the play of chance, confounding, or a true effect of GTN, further randomized evidence on the use
of vasodilators in ultra-acute intracerebral hemorrhage is needed.

Keywords:stroke, glyceryl trinitrate, GTN, nitroglycerin, multicentre, randomised controlled trial, intracerebral hemorrhage, modified Rankin Scale, blood pressure, ambulances, United Kingdom, Allied Health Personnel, human
Subjects:A Medicine and Dentistry > A300 Clinical Medicine
B Subjects allied to Medicine > B990 Subjects Allied to Medicine not elsewhere classified
Divisions:College of Social Science > School of Health & Social Care
ID Code:37993
Deposited On:23 Oct 2019 08:08

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