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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Vydané v:	Journal of thrombosis and haemostasis Ročník 3; číslo 4; s. 692 - 694
Hlavní autori:	SCHULMAN, S., KEARON, C.
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	Oxford, UK Blackwell Publishing Ltd 01.04.2005
Predmet:	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
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Popis
Shrnutí:	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.
Bibliografia:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1538-7933 1538-7836 1538-7836
DOI:	10.1111/j.1538-7836.2005.01204.x