We limited our literature review to trials in patients with AF and VTE because the work of the Bleeding Academic Research Consortium has already addressed this issue in other cardiovascular trials 3. Conflicting author opinions were resolved by consensus and the original draft manuscript was approved by the SSC co-chairs. The authors worked with the chair of the SSC Subcommittee on Control of Anticoagulation and presented the planned literature search, study inclusion criteria and data abstraction strategy at the 60th SSC meeting in 2014 for comments and feedback, which were incorporated into recommendations. The purpose of this ISTH SSC recommendation is to provide a standard definition of CRNMB that can be used in clinical trials, registries, and cohort studies of AF and VTE and can be applied uniformly in pooled systematic reviews and by regulatory authorities. Food and Drug Administration (FDA), the National Institutes of Health, pharmaceutical and cardiovascular device manufacturers, and independent physician thought leaders to standardize bleeding definitions 3.ДЄlthough much work has been done to harmonize the definition of major bleeding, there have been no attempts for CRNMB. In an attempt to standardize the definition of bleeding in acute coronary syndromes, the Bleeding Academic Research Consortium convened a meeting with representatives from academic research organizations, the U.S. The European Medicines Agency draft guideline on clinical investigation of medicinal products for the prevention of stroke and systemic embolic events in patients with non-valvular AF is closely aligned with this definition 2. Responding to the wide range of definitions of major bleeding in clinical trials, several groups have released recommendations to standardize the definition of вЂmajor bleeding.вЂ™ The subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee (SSC) established a standard definition of major bleeding in non-surgical patients 1. This relatively new term for anticoagulant-related bleeding suffers the same lack of harmonization as major bleeding did a decade ago. The term вЂclinically relevant non-major bleedingвЂ™ (CRNMB) has recently been incorporated into the outcomes of atrial fibrillation (AF) and venous thromboembolic (VTE) disease clinical trials to further define a bleeding event that is neither a major bleed as defined by the International Society on Thrombosis and Haemostasis (ISTH) 1 nor a nonвЂ“clinically consequential minor bleeding event.

Timi bleeding