现在的位置: 首页时讯速递, 进展交流>正文
[Lancet发表论文]:蛛网膜下腔出血后极早期氨甲环酸治疗(ULTRA)
2021年02月09日 时讯速递, 进展交流 暂无评论

ARTICLES|ONLINE FIRST

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

René Post, Menno R Germans, Maud A Tjerkstra, et al.

Lancet Published:December 21, 2020 DOI:https://doi.org/10.1016/S0140-6736(20)32518-6

Summary

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.govNCT02684812.

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.

给我留言

您必须 [ 登录 ] 才能发表留言!

×
腾讯微博