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

Authors

  • S. SCHULMAN,

    1. Coagulation Unit, Karolinska University Hospital, Stockholm, Sweden and Department of Medicine, HHS-General Hospital, Hamilton, ON, Canada
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  • C. KEARON,

    1. Henderson General Hospital, Hamilton, ON, Canada
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  • the SUBCOMMITTEE ON CONTROL OF ANTICOAGULATION OF THE SCIENTIFIC AND STANDARDIZATION COMMITTEE OF THE INTERNATIONAL SOCIETY ON THROMBOSIS AND HAEMOSTASIS

    1. Coagulation Unit, Karolinska University Hospital, Stockholm, Sweden and Department of Medicine, HHS-General Hospital, Hamilton, ON, Canada
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Sam Schulman MD, HHS-General Hospital, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
e-mail: schulms@mcmaster.ca

Abstract

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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