Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium

R Mehran, SV Rao, DL Bhatt, CM Gibson, A Caixeta… - Circulation, 2011 - Am Heart Assoc
Advances in antithrombotic therapy, along with an early invasive strategy, have reduced the
incidence of recurrent ischemic events and death in patients with acute coronary syndromes
(ACS; unstable angina, non–ST-segment–elevation myocardial infarction [MI], and ST-
segment–elevation MI). 1–4 However, the combination of multiple pharmacotherapies,
including aspirin, platelet P2Y12 inhibitors, heparin plus glycoprotein IIb/IIIa inhibitors, direct
thrombin inhibitors, and the increasing use of invasive procedures, has also been …

[PDF][PDF] Standardized bleeding definitions for cardiovascular clinical trials

D Taggart, M Valgimigli, DL Bhatt, EM Ohman… - Circulation, 2011 - regionstrauma.org
reported to cause death) o Symptomatic intracranial hemorrhage o Retroperitoneal
hemorrhage o Intraocular hemorrhage leading to significant vision loss o Decrease in
hemoglobin of at least 3.0 g/dL (with each blood transfusion unit counting for 1.0 g/dL
hemoglobin) o Bleeding requiring transfusion of ≥2 U RBCs or equivalent of whole blood Minor o
All other clinically significant bleeding not meeting the definition for major bleeding and that led to
interruption of the study drug for at least 24 h, surgical intervention, or transfusion of ≤1 U blood
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