Tranexamic Acid After Aneurysmal Subarachnoid Hemorrhage: Post-Hoc Analysis of the ULTRA Trial

Department of Neurosurgery, Amsterdam Neuroscience Research Institute, Amsterdam University Medical Centres, Amsterdam, the Netherlands m.a.tjerkstra@amsterdamumc.nl. Department of Neurosurgery, Amsterdam Neuroscience Research Institute, Amsterdam University Medical Centres, Amsterdam, the Netherlands. Department of Neurosurgery, Clinical Neuroscience Centre, University Hospital Zurich, Zurich, Switzerland. Department of Neurology and Neurosurgery, UMC Utrecht Brain Centre, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands. Department of Neurology, Haaglanden Medical Centre, The Hague, the Netherlands. Department of Neurosurgery, Leids University Medical Centre, the Netherlands. Department of Neurology, Leids University Medical Centre, the Netherlands. Department of Neurosurgery, Haaglanden Medical Centre, The Hague, the Netherlands. Department of Neurosurgery, Isala Hospital, Zwolle, the Netherlands. Department of Intensive Care, Isala Hospital, Zwolle, the Netherlands. Department of Neurosurgery, Elisabeth Tweesteden ziekenhuis, Tilburg, the Netherlands. Department of Neurology, Elisabeth Tweesteden ziekenhuis, Tilburg, the Netherlands. Department of Neurology, Spaarne Gasthuis, Haarlem, the Netherlands. Department of Neurology, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands. Department of Neurology, Ziekenhuisgroep Twente, Almelo, the Netherlands. Department of Neurology, Medisch Spectrum Twente, Enschede, the Netherlands. Department of Neurology, OLVG, Amsterdam, the Netherlands. Department of Neurology, Amsterdam University Medical Centres, location AMC, Amsterdam, the Netherlands. Department of Neurology, Dijklander Hospital, Hoorn, the Netherlands. Department of Neurology, Flevo Hospital, Almere, the Netherlands. Department of Neurology, Gelre Hospital, Apeldoorn, The Netherlands. Department of Neurosurgery, Radboud University Medical Centre, Nijmegen, the Netherlands. Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, the Netherlands. Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centres, location AMC, Amsterdam, the Netherlands. Department of Intensive Care, Amsterdam University Medical Centres, location AMC, Amsterdam, the Netherlands.

Neurology. 2022
Abstract
BACKGROUND AND OBJECTIVES The ULTRA-trial showed that ultra-early and short-term tranexamic acid treatment after subarachnoid hemorrhage did not improve clinical outcome at six months. An expected proportion of the included patients had non-aneurysmal subarachnoid hemorrhage In this post-hoc study, we will investigate whether ultra-early and short-term tranexamic acid treatment in patients with aneurysmal subarachnoid hemorrhage improves clinical outcome at six months. METHODS The ULTRA-trial is a multicenter, prospective, randomized, controlled, open-label trial with blinded outcome assessment, conducted between July 24, 2013 and January 20, 2020. After confirmation of subarachnoid hemorrhage on non-contrast computer tomography, patients were allocated to either ultra-early and short-term tranexamic acid treatment with usual care, or usual care only. In this post-hoc analysis, we included all ULTRA-participants with a confirmed aneurysm on CT angiography and/or digital subtraction angiography. The primary endpoint was clinical outcome at six months, assessed by the modified Rankin Scale, dichotomized into good (0-3) and poor (4-6) outcome. RESULTS Of the 813 ULTRA-trial patients who had an aneurysmal subarachnoid hemorrhage, 409 (50%) were assigned to the tranexamic acid group and 404 (50%) to the control group. In the intention-to-treat analysis, 233 of 405 (58%) patients in the tranexamic acid group and 238 of 399 (60%) patients in the control group had a good clinical outcome (adjusted odds ratio (aOR) 0·92; 95% confidence interval (C.I.) 0·69 to 1·24). None of the secondary outcomes showed significant differences between the treatment groups: excellent clinical outcome (mRS 0-2) aOR 0.76, 95% C.I. 0.57-1.03, all-cause mortality at 30 days aOR 0.91, 95% C.I. 0.65-1.28), all-cause mortality at six months aOR 1.10 (95% C.I. 0.80-1.52). DISCUSSION Ultra-early and short-term tranexamic acid treatment did not improve clinical outcome at six months in patients with aneurysmal subarachnoid hemorrhage and therefore, cannot be recommended. TRIAL REGISTRATION ClinicalTrials.gov (NCT02684812; submission date February 18, 2016, first patient enrollment on July 24(th), 2013). CLASSIFICATION OF EVIDENCE This study provides Class II evidence that tranexamic acid does not improve outcomes in patients presenting with aneurysmal subarachnoid hemorrhage.
Study details
Language : eng
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