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The effect of tranexamic acid by baseline risk in acute bleeding patients: a meta-analysis of individual patient-level data from 28 333 patients.
Version 2 2020-05-21, 16:07
Version 1 2020-05-21, 16:06
journal contribution
posted on 2020-05-21, 16:07 authored by Francois-Xavier Ageron, Angele Gayet-Ageron, Katharine Ker, Timothy J Coats, Haleema Shakur-Still, Ian Roberts, Antifibrinolytics Trials CollaborationBACKGROUND:Early administration of the antifibrinolytic drug tranexamic acid reduces death from bleeding in trauma and postpartum haemorrhage. We examined how the effectiveness and safety of antifibrinolytic drugs varies by the baseline risk of death as a result of bleeding. METHODS:We performed an individual patient-level data meta-analysis of randomised trials including more than 1000 patients that assessed antifibrinolytics in acute severe bleeding. We identified trials performed between January 1, 1946 and July 5, 2018 (PROSPERO, number 42016052155). RESULTS:Two randomised trials were selected where 28 333 patients received tranexamic acid treatment within 3 h after the onset of acute bleeding. Baseline characteristics to estimate the risk of death as a result of bleeding were divided into four categories: Low (0-5%), intermediate (6-10%), high (11-20%), and very high (>20%). Most patients had a low baseline risk of death as a result of bleeding (23 008 [81%]). Deaths as a result of bleeding occurred in all baseline risk categories with 240 (1%), 202 (8%), 232 (14%), and 357 (30%) deaths in the low-, intermediate-, high-, and very high-risk categories, respectively. The effectiveness of tranexamic acid did not vary by baseline risk when given within 3 h after bleeding onset (P=0.51 for interaction term). There was no increased risk of vascular occlusive events with tranexamic acid and it did not vary by baseline risk categories (P=0.25). CONCLUSIONS:Tranexamic acid appears to be safe and effective regardless of baseline risk. Because many deaths are in patients at low and intermediate risk, tranexamic acid use should not be restricted to the most severely injured or bleeding patients.
Funding
Wellcome Trust (grant 208870 to IR and HSS).
History
Citation
British Journal of Anaesthesia Volume 124, Issue 6, June 2020, Pages 676-683Version
- VoR (Version of Record)
Published in
British journal of anaesthesiaVolume
124Issue
6Pagination
676-683Publisher
Elsevierissn
0007-0912eissn
1471-6771Acceptance date
2020-01-27Copyright date
2020Publisher DOI
Publisher version
Notes
This article is accompanied by an editorial: Tranexamic acid: the king is dead, long live the king! by Lier & Shander, Br J Anaesth 2020:124:659–662, doi: 10.1016/j.bja.2020.02.015Language
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