Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026
Quality of life after tranexamic acid in subarachnoid hemorrhage: post-hoc analysis of the ULTRA trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Denneman Nadine, Kamra Tanvi, Post René, Tjerkstra Maud A, Germans Menno R, Vergouwen Mervyn D I, Jellema Korné, Koot Radboud W, Kruyt Nyika D, Wolfs Jasper F C, Nanda Dharmin, Van Der Pol Bram, Roks Gerwin, Reichman Loes J A, Brouwers Paul J A M, Kwa Vincent I H, Bienfait Henri P, Boogaarts Hieronymus D, Klijn Catharina J, van den Berg René, Coert Bert A, Horn Janneke, Majoie Charles B L M, Rinkel Gabriël J E, Roos Yvo B W E M, Vandertop W Peter, Verbaan Dagmar, ULTRA trial study group
Аннотация
PURPOSE: The ULTRA trial evaluated the impact of ultra-early and short-term tranexamic acid (TXA) treatment in patients with subarachnoid hemorrhage (SAH) and found no clinical benefit at six months. This post-hoc analysis examines whether TXA improves quality of life (QoL) at three and six months.
METHODS: The ULTRA trial was a randomized, controlled, multicenter study conducted from July 2013 to July 2019. Patients received either TXA or standard care. This analysis included patients who completed at least one QoL questionnaire. The primary endpoint was QoL, assessed using the EQ-5D-3L questionnaire at three and six months. Linear mixed models adjusted for confounders were used to analyze the association between TXA and QoL.
RESULTS: Of the 955 ULTRA patients, approximately 25% died, and 63% completed at least one QoL questionnaire. At three months, the TXA group had a mean EQ-5D index score of 0.75 versus 0.71 in the control group (p = 0.11) and a mean EQ-5D Visual Analogue Scale (VAS) score of 89 versus 86 (p = 0.10). At six months, the mean EQ-5D index score was 0.84 in the TXA group compared to 0.82 in the control group (p = 0.23), and the mean VAS was 92 in the TXA group compared to 89 in the control group (p = 0.13).
CONCLUSION: Ultra-early and short-term TXA did not result in a significant improvement in QoL at three or six months in patients with SAH. Given the lack of benefit on both clinical outcome and QoL, routine use of TXA is not recommended.
TRIAL REGISTRATION: Netherlands Trial Register: NTR3272.
CLINICALTRIALS: gov: NCT02684812.
METHODS: The ULTRA trial was a randomized, controlled, multicenter study conducted from July 2013 to July 2019. Patients received either TXA or standard care. This analysis included patients who completed at least one QoL questionnaire. The primary endpoint was QoL, assessed using the EQ-5D-3L questionnaire at three and six months. Linear mixed models adjusted for confounders were used to analyze the association between TXA and QoL.
RESULTS: Of the 955 ULTRA patients, approximately 25% died, and 63% completed at least one QoL questionnaire. At three months, the TXA group had a mean EQ-5D index score of 0.75 versus 0.71 in the control group (p = 0.11) and a mean EQ-5D Visual Analogue Scale (VAS) score of 89 versus 86 (p = 0.10). At six months, the mean EQ-5D index score was 0.84 in the TXA group compared to 0.82 in the control group (p = 0.23), and the mean VAS was 92 in the TXA group compared to 89 in the control group (p = 0.13).
CONCLUSION: Ultra-early and short-term TXA did not result in a significant improvement in QoL at three or six months in patients with SAH. Given the lack of benefit on both clinical outcome and QoL, routine use of TXA is not recommended.
TRIAL REGISTRATION: Netherlands Trial Register: NTR3272.
CLINICALTRIALS: gov: NCT02684812.