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Ultra-early tranexamic acid after subarachnoid haemorrhage (ULTRA): a randomised controlled trial

Authors :
René Post
Menno R Germans
Maud A Tjerkstra
Mervyn D I Vergouwen
Korné Jellema
Radboud W Koot
Nyika D Kruyt
Peter W A Willems
Jasper F C Wolfs
Frits C de Beer
Hans Kieft
Dharmin Nanda
Bram van der Pol
Gerwin Roks
Frank de Beer
Patricia H A Halkes
Loes J A Reichman
Paul J A M Brouwers
Renske M van den Berg-Vos
Vincent I H Kwa
Taco C van der Ree
Irene Bronner
Janneke van de Vlekkert
Henri P Bienfait
Hieronymus D Boogaarts
Catharina J M Klijn
René van den Berg
Bert A Coert
Janneke Horn
Charles B L M Majoie
Gabriël J E Rinkel
Yvo B W E M Roos
W Peter Vandertop
Dagmar Verbaan
Menno R. Germans
Maud A. Tjerkstra
Mervyn D.I. Vergouwen
Radboud W. Koot
Nyika D. Kruyt
Peter W.A. Willems
Jasper F.C. Wolfs
Frits C. de Beer
Patricia H.A. Halkes
Loes J.A. Reichman
Paul J.A.M. Brouwers
Renske M. van den Berg-Vos
Vincent I.H. Kwa
Taco C. van der Ree
Henri P. Bienfait
Hieronymus D. Boogaarts
Catharina J.M. Klijn
Martine van Bilzen
H.J.G. Dieks
Koen de Gans
J.B.M. ten Holter
Jelle R. de Kruijk
Charlie T.J.M. Leijzer
Delmar Molenaar
Robbert J. van Oostenbrugge
Jeske van Pamelen
Fianne H.M. Spaander
Sarah E. Vermeer
J. Manuela Voorend
Bert A. Coert
Charles B.L.M. Majoie
Gabriël J.E. Rinkel
Yvo B.W.E.M. Roos
W. Peter Vandertop
Neurosurgery
Amsterdam Neuroscience - Neurovascular Disorders
Neurology
Radiology and nuclear medicine
VU University medical center
ACS - Atherosclerosis & ischemic syndromes
Graduate School
ANS - Systems & Network Neuroscience
ANS - Neurovascular Disorders
Experimental Vascular Medicine
Radiology and Nuclear Medicine
ACS - Microcirculation
Source :
Lancet, 397(10269), 112-118. Elsevier Limited, The Lancet (London), 397, 10269, pp. 112-118, ULTRA Investigators 2021, ' Ultra-early tranexamic acid after subarachnoid haemorrhage (ULTRA) : a randomised controlled trial ', Lancet, vol. 397, no. 10269, pp. 112-118 . https://doi.org/10.1016/S0140-6736(20)32518-6, The Lancet (London), 397, 112-118, The Lancet, 397(10269), 112-118. ELSEVIER SCIENCE INC
Publication Year :
2021

Abstract

BACKGROUND: In patients with aneurysmal subarachnoid haemorrhage, short-term antifibrinolytic therapy with tranexamic acid has been shown to reduce the risk of rebleeding. However, whether this treatment improves clinical outcome is unclear. We investigated whether ultra-early, short-term treatment with tranexamic acid improves clinical outcome at 6 months.METHODS: In this multicentre prospective, randomised, controlled, open-label trial with masked outcome assessment, adult patients with spontaneous CT-proven subarachnoid haemorrhage in eight treatment centres and 16 referring hospitals in the Netherlands were randomly assigned to treatment with tranexamic acid in addition to care as usual (tranexamic acid group) or care as usual only (control group). Tranexamic acid was started immediately after diagnosis in the presenting hospital (1 g bolus, followed by continuous infusion of 1 g every 8 h, terminated immediately before aneurysm treatment, or 24 h after start of the medication, whichever came first). The primary endpoint was clinical outcome at 6 months, assessed by the modified Rankin Scale, dichotomised into a good (0-3) or poor (4-6) clinical outcome. Both primary and safety analyses were according to intention to treat. This trial is registered at ClinicalTrials.gov, NCT02684812.FINDINGS: Between July 24, 2013, and July 29, 2019, we enrolled 955 patients; 480 patients were randomly assigned to tranexamic acid and 475 patients to the control group. In the intention-to-treat analysis, good clinical outcome was observed in 287 (60%) of 475 patients in the tranexamic acid group, and 300 (64%) of 470 patients in the control group (treatment centre adjusted odds ratio 0·86, 95% CI 0·66-1·12). Rebleeding after randomisation and before aneurysm treatment occurred in 49 (10%) patients in the tranexamic acid and in 66 (14%) patients in the control group (odds ratio 0·71, 95% CI 0·48-1·04). Other serious adverse events were comparable between groups.INTERPRETATION: In patients with CT-proven subarachnoid haemorrhage, presumably caused by a ruptured aneurysm, ultra-early, short-term tranexamic acid treatment did not improve clinical outcome at 6 months, as measured by the modified Rankin Scale.FUNDING: Fonds NutsOhra.

Details

ISSN :
01406736
Volume :
397
Database :
OpenAIRE
Journal :
The Lancet (London)
Accession number :
edsair.doi.dedup.....98e5e1fd5d199b7b501d62c543ae76f9
Full Text :
https://doi.org/10.1016/S0140-6736(20)32518-6