Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Nov;18(11):2852-2860.
doi: 10.1111/jth.15048. Epub 2020 Sep 11.

Definition of major bleeding: Prognostic classification

Laura Franco  1 , Cecilia Becattini  1 , Jan Beyer-Westendorf  2 , Simone Vanni  3 , Cinzia Nitti  4 , Roberta Re  5 , Giorgia Manina  6 , Fulvio Pomero  7 , Roberto Cappelli  8 , Alberto Conti  9 , Giancarlo Agnelli  1
Affiliations
Free article

Definition of major bleeding: Prognostic classification

Laura Franco et al. J Thromb Haemost. 2020 Nov.
Free article

Abstract

Background: In patients on anticoagulant treatment, the major bleeding (MB) definition released by the International Society of Thrombosis and Haemostasis (ISTH) is widely accepted. However, this definition identifies MBs with highly variable short-term risk of death.

Objectives: The study aims were to derive and validate a classification of ISTH-defined MBs for the risk of short-term death.

Methods: Consecutive patients admitted for ISTH-defined MB occurring while on treatment with oral anticoagulants were included in the study and divided into a derivation and a validation cohort. Death within 30 days was the primary study outcome.

Results: Among 1077 patients with MB, 64/517 and 63/560 patients in the derivation and validation cohort died, respectively. In the derivation cohort, Glasgow coma scale (GCS) <14 and shock were predictors of death; critical site bleeding and hemoglobin decrease ≥2 g/dL, or transfusion ≥ 2 units were not. GCS <14 (hazard ratio [HR], 8.67; 95% confidence interval [CI], 3.93-19.13) was predictor of death in intracranial hemorrhage (ICH) and shock at admission (HR, 4.84; 95% CI, 2.01-11.70) and pericardial bleeding (HR, 11.37; 95% CI, 1.33-97.31) in non-ICH MBs. The predictive value of GCS <14 in ICH and shock and pericardial bleeding in non-ICH MBs was confirmed in the validation cohort. None of the patients with isolated ocular or articular bleeding died. A prognostic classification of ISTH-defined MBs for the risk of short-term death is proposed as "serious," "severe," and "life-threatening" (ICH with GCS <14 or non-ICH with shock) MBs.

Conclusion: According to our study, ISTH-defined MBs can be stratified for the risk of death within 30 days.

Keywords: anticoagulants; bleeding; classification; hemorrhage; mortality.

PubMed Disclaimer

References

REFERENCES

    1. Schulman S, Kearon C. Subcommittee on control of anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005;3(4):692-694.
    1. Becattini C, Franco L, Beyer-Westendorf J, et al. Major bleeding with vitamin K antagonists or direct oral anticoagulants in real-life. Int J Cardiol. 2017;15(227):261-266.
    1. Eerenberg ES, Middeldorp S, Levi M, et al. Clinical impact and course of major bleeding with rivaroxaban and vitamin K antagonists. J Thromb Haemost. 2015;13:1590-1596.
    1. Brekelmans MP, Bleker SM, Bauersachs R, et al. Clinical impact and course of major bleeding with edoxaban versus vitamin K antagonists. Thromb Haemost. 2016;116:155-161.
    1. Bleker SM, Cohen AT, Buller HR, et al. Clinical presentation and course of bleeding events in patients with venous thromboembolism, treated with apixaban or enoxaparin and warfarin. Results from the AMPLIFY trial. Thromb Haemost. 2016;116:1159-1164.