Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non‐surgical patients

A variety of definitions of major bleeding have been used in published clinical studies, and this diversity adds to the difficulty in comparing data between trials and in performing meta‐analyses. In the first step towards unified definitions of bleeding complications, the definition of major bleedi...

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Bibliographic Details
Published in:Journal of thrombosis and haemostasis Vol. 3; no. 4; pp. 692 - 694
Main Authors: SCHULMAN, S., KEARON, C.
Format: Journal Article
Language:English
Published: Oxford, UK Blackwell Publishing Ltd 01.04.2005
Subjects:
Anticoagulants - adverse effects
Anticoagulants - pharmacology
anticoagulation
definition
fibrinolysis
Fibrinolytic Agents - adverse effects
Fibrinolytic Agents - pharmacology
Hematology - standards
hemorrhage
Hemorrhage - chemically induced
Hemorrhage - mortality
Hemorrhage - therapy
Hemostasis
Humans
Platelet Aggregation Inhibitors - adverse effects
Platelet Aggregation Inhibitors - pharmacology
platelet inhibition
Postoperative Complications
ISSN:1538-7933, 1538-7836, 1538-7836
Online Access:Get full text
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Summary:A variety of definitions of major bleeding have been used in published clinical studies, and this diversity adds to the difficulty in comparing data between trials and in performing meta‐analyses. In the first step towards unified definitions of bleeding complications, the definition of major bleeding in non‐surgical patients was discussed at the Control of Anticoagulation Subcommittee of the International Society on Thrombosis and Haemostasis. Arising from that discussion, a definition was developed that should be applicable to studies with all agents that interfere with hemostasis, including anticoagulants, platelet function inhibitors and fibrinolytic drugs. The definition and the text that follows have been reviewed and approved by the cochairs of the subcommittee and the revised version is published here. The intention is to also seek approval of this definition from the regulatory authorities.
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ISSN:1538-7933
1538-7836
1538-7836
DOI:10.1111/j.1538-7836.2005.01204.x