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Meta-Analysis
. 2020 Jun;124(6):676-683.
doi: 10.1016/j.bja.2020.01.020. Epub 2020 Mar 19.

Effect of tranexamic acid by baseline risk of death in acute bleeding patients: a meta-analysis of individual patient-level data from 28 333 patients

Francois-Xavier Ageron  1 , Angele Gayet-Ageron  2 , Katharine Ker  3 , Timothy J Coats  4 , Haleema Shakur-Still  3 , Ian Roberts  3 ; Antifibrinolytics Trials Collaboration
Collaborators, Affiliations
Meta-Analysis

Effect of tranexamic acid by baseline risk of death in acute bleeding patients: a meta-analysis of individual patient-level data from 28 333 patients

Francois-Xavier Ageron et al. Br J Anaesth. 2020 Jun.

Abstract

Background: 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 of death. 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.

Keywords: antifibrinolytics; bleeding; coagulopathy; mortality; postpartum haemorrhage; trauma.

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Conflict of interest statement

The authors declare that they have no conflicts of interest.

Figures

Fig 1
Fig 1
Study selection. TXA, tranexamic acid.
Fig 2
Fig 2
Number of patients and number of deaths according to baseline risk.
Fig 3
Fig 3
Effect of tranexamic acid on death as a result of bleeding by baseline risk. CI, confidence interval.
Fig 4
Fig 4
Effect of baseline risk on treatment benefit. CI, confidence interval.
See this image and copyright information in PMC

Comment in

References

    1. Gayet-Ageron A., Prieto-Merino D., Ker K. Effect of treatment delay on the effectiveness and safety of antifibrinolytics in acute severe haemorrhage: a meta-analysis of individual patient-level data from 40 138 bleeding patients. Lancet. 2018;391:125–132. - PMC - PubMed
    1. World Health Organization . 21th edition. 2019. WHO model lists of essential medicines.https://www.who.int/medicines/publications/essentialmedicines/en/ Available from:
    1. Vogel J.P., Oladapo O.T., Dowswell T., Gülmezoglu A.M. Updated WHO recommendation on intravenous tranexamic acid for the treatment of post-partum haemorrhage. Lancet Glob Health. 2018;6:e18–e19. - PubMed
    1. Spahn D.R., Bouillon B., Cerny V. The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition. Crit Care. 2019;23:98. - PMC - PubMed
    1. Committee on Trauma of the American College of Surgeons . American College of Surgeons; Chicago, Il: 2019. ACS TQIP massive transfusion in trauma guidelines.

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