Tranexamic Acid After Aneurysmal Subarachnoid Hemorrhage: Post-Hoc Analysis of the ULTRA Trial
Tjerkstra, Maud A; Post, Rene; Germans, Menno R; Vergouwen, Mervyn D I; Jellema, Korné; Koot, Radboud W; Kruyt, Nyika D; Willems, Peter W A; Wolfs, Jasper F C; de Beer, Frits C; Kieft, Hans; Nanda, Dharmin; van der Pol, Bram; Roks, Gerwin; de Beer, Frank; Halkes, Patricia H A; Reichman, Loes J A; Brouwers, Paul J A M; Van den Berg-Vos, Renske M; Kwa, Vincent I H; van der Ree, Taco C; Bronner, Irene; Bienfait, Henri P; Boogaarts, Hieronymus; Klijn, Catharina Jm; van den Berg, René; Coert, Bert A; Horn, Janneke; Majoie, Charles B L M; Rinkel, Gabriël J E; Roos, Yvo B W M; Vandertop, William; Verbaan, Dagmar
(2022) Neurology, volume 99, issue 23, pp. E2605 - E2614
(Article)
Abstract
Background and ObjectivesThe ULTRA trial showed that ultra-early and short-term tranexamic acid treatment after subarachnoid hemorrhage did not improve clinical outcome at 6 months. An expected proportion of the included patients experienced nonaneurysmal subarachnoid hemorrhage. In this post hoc study, we will investigate whether ultra-early and short-term tranexamic acid treatment
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in patients with aneurysmal subarachnoid hemorrhage improves clinical outcome at 6 months.MethodsThe 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 noncontrast CT, 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 6 months, assessed by the modified Rankin scale (mRS), dichotomized into good (0-3) and poor (4-6) outcomes.ResultsOf the 813 ULTRA trial patients who experienced 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% CI 0.69-1.24). None of the secondary outcomes showed significant differences between the treatment groups: excellent clinical outcome (mRS 0-2) (aOR 0.76; 95% CI 0.57-1.03), all-cause mortality at 30 days (aOR 0.91; 95% CI 0.65-1.28), and all-cause mortality at 6 months (aOR 1.10; 95% CI 0.80-1.52).DiscussionUltra-early and short-term tranexamic acid treatment did not improve clinical outcomes at 6 months in patients with aneurysmal subarachnoid hemorrhage and therefore cannot be recommended.Trial Registration InformationClinicalTrials.gov (NCT02684812; submission date February 18, 2016, first patient enrollment on July 24, 2013).Classification of EvidenceThis study provides Class II evidence that tranexamic acid does not improve outcomes in patients presenting with aneurysmal subarachnoid hemorrhage.
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Keywords: Clinical Neurology, Journal Article
ISSN: 0028-3878
Publisher: Lippincott Williams & Wilkins
Note: Funding Information: M.D.I. Vergouwen reports a grant from the Dutch Heart Foundation (Clinical Established Investigator grant 2018T076). J.F.C. Wolfs reports personal fees from Consultant Nuvasive, personal fees from Zimmer Biomet, personal fees from Safe Orthopaedics, personal fees from EIT/Johnson and Johnson, outside the submitted work. H.D. Boogaarts reports consulting fees paid to the Department of Neurosurgery Radboud University Medical Center Nijmegen from Stryker neurovascular. C.J.M. Klijn reports grants from Clinical established investigator grant of the Dutch Heart Foundation (Grant Number 2012T077), grants from ASPASIA, grant from The Netherlands Organization for Health Research and Development, ZonMw (Grant Number 015008048), grants from Support of the Netherlands Cardiovascular Research Initiative, which is supported by the Dutch Heart Foundation, CVON2015–01: CONTRAST, and the support of the Brain Foundation Netherlands (HA2015 01·06), outside the submitted work. R. van den Berg reports consulting fees for unrelated research and teaching activities from Cerenovus Neurovascular. C.B.L.M. Majoie reports grants from CVON/Dutch Heart Foundation, grants from European Commission, grants from Dutch Health Evaluation Program, grants from TWIN Foundation, grants from Stryker, outside the submitted work and is a Shareholder of Nico-Lab, a company that focuses on the use of artificial intelligence for medical image analysis. G.J.E. Rinkel reports no disclosures relevant to the manuscript. Y.B.W.E.M. Roos is a minor stockholder of Nico-Lab. The other authors report no relevant disclosures. Go to Neurology.org/N for full disclosures. Publisher Copyright: © 2022 American Academy of Neurology.
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