Definitions of fatal bleeding in clinical studies evaluating anticoagulant treatment for venous thromboembolism: A scoping review.

Schenker, Carla; Marx, Caterina E; Kraaijpoel, Noémie; Le Gal, Grégoire; Siegal, Deborah M; Klok, Frederikus A; Aujesky, Drahomir; Tritschler, Tobias (2023). Definitions of fatal bleeding in clinical studies evaluating anticoagulant treatment for venous thromboembolism: A scoping review. Journal of thrombosis and haemostasis, 21(6), pp. 1553-1566. Elsevier 10.1016/j.jtha.2023.02.013

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Fatal bleeding is a component of the primary safety outcome in most studies evaluating anticoagulation for venous thromboembolism (VTE), but a standardized definition for fatal bleeding is lacking.


To summarize definitions of fatal bleeding, and to describe the range of case-fatality rates of major bleeding in VTE studies.


MEDLINE, Embase, and CENTRAL were searched from 01/2008-07/2021, for prospective studies that enrolled patients with VTE and evaluated the efficacy/safety of anticoagulation for VTE treatment or included fatal or major bleeding as primary outcome. Two authors independently performed study selection and data extraction. The primary outcome was the definition of fatal bleeding. The secondary outcome was the case-fatality rate of major bleeding. Data were analyzed using descriptive statistics.


Of 4,911 records identified, we included 132 articles representing 89 distinct studies. Twenty-seven (20%) articles and 7 of 89 (8%) studies reported a definition of fatal bleeding. Overall, we identified three different types of definitions that were either based on a specific time interval between bleeding and death, bleeding location (intracranial) or clinical presentation (hemodynamic deterioration), or mainly relied on the judgment of the adjudication committee to determine the cause of death. The case-fatality rate of major bleeding ranged from 0 to 60% (median, 9.1%; interquartile range, 2.8-18%).


Less than 10% of studies assessing anticoagulant treatment for VTE reported a definition for fatal bleeding. The lack of a (standardized) definition for fatal bleeding may lead to inaccurate estimates of the risk of fatal bleeding, particularly when comparing across studies.

Item Type:

Journal Article (Original Article)


04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine

UniBE Contributor:

Schenker, Carla, Marx, Caterina Eva, Aujesky, Drahomir, Tritschler, Tobias


600 Technology > 610 Medicine & health








Pubmed Import

Date Deposited:

03 Mar 2023 17:10

Last Modified:

15 May 2023 00:13

Publisher DOI:


PubMed ID:


Uncontrolled Keywords:

Anticoagulation Bleeding Cause of death Outcome assessment Venous thromboembolism


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