학술논문
Tranexamic Acid After Aneurysmal Subarachnoid Hemorrhage: Post Hoc Analysis of the ULTRA Trial
Document Type
Academic Journal
Author
Tjerkstra, Maud A.; Post, René; 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 J.M.; van den Berg, René; Coert, Bert A.; Horn, Janneke; Majoie, Charles B.L.M.; Rinkel, Gabriël J.E.; Roos, Yvo B.W.M.; Vandertop, W. Peter; Verbaan, Dagmar
Source
Neurology. Dec 06, 2022 99(23):e2605-e2614
Subject
Language
English
ISSN
0028-3878
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 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 in patients with aneurysmal subarachnoid hemorrhage improves clinical outcome at 6 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 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. RESULTS: Of 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). DISCUSSION: Ultra-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 INFORMATION: ClinicalTrials.gov (NCT02684812; submission date February 18, 2016, first patient enrollment on July 24, 2013). CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that tranexamic acid does not improve outcomes in patients presenting with aneurysmal subarachnoid hemorrhage.