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|SSC Control of Anticoagulation Subcommittee|
Participation Invited: SSC Control of Anticoagulation Subcommittee Works to Standardize the Definition of Clinical Outcome for Patients Treated for a Major Oral Anticoagulant Related Bleed
A variety of definitions for clinical outcome have been used in published clinical studies on emergency treatment of oral anticoagulant related bleed. This diversity hampers any attempt to compare data between trials and in performing meta-analysis. Yet, with no doubt, clinical outcome is the most important parameter for evaluating treatment effects. Moreover, direct oral anticoagulants lack specific surrogate laboratory parameters, which make the need for a standardized clinical outcome parameter even more urgent, especially now that new antidotes to treat (direct) oral anticoagulant associated bleed are being investigated in phase III trials.
In the first step towards unified definitions of bleeding complications, a definition for major bleeding in non-surgical patients was developed by Sam Schulman and Clive Kearon on behalf of the Control of Anticoagulation SSC Subcommittee of the ISTH. This definition is nowadays applicable to studies with all agents that interfere with haemostasis, including anticoagulants, platelet function inhibitors and fibrinolytic agents.
To move to the next step, the Control of Anticoagulation Subcommittee would like to propose development of a unified and practical formulation for clinical outcome after treatment of a major bleed. This definition should be applicable for treatment of both old and new oral anticoagulant associated bleeds as well as all other agents for which the definition of major bleed applied.
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