103 FRAIL-AF RANDOMISED CONTROLLED TRIAL: RATIONALE AND DESIGN S2: PRIMARY AND SECONDARY OUTCOMES. Primary outcome Major or clinically relevant non-major bleeding complicationsa,b Secondary outcomes Major bleeding complicationsa Clinically relevant non-major bleeding complicationsb Minor bleeding complicationsc Composite of major or clinically relevant non-major bleeding complications and thromboembolic eventsa,b,d Thromboembolic eventsd Ischaemic and haemorrhagic stroke Health-related quality of life Cost-effectiveness Identification of risk factors for bleeding a Major bleeding complication according to the definition of the ISTH: fatal bleeding, and/or bleeding in a critical area or organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome), and/or bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or reds cells. b Clinically relevant non-major bleeding complication according to the definition of the ISTH: any sign or symptom of haemorrhage (for example, more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH-definition of major bleeding but does meet at least one of the following criteria: bleeding requiring medical intervention by a healthcare professional, and/or leading to hospitalisation or increased level of care, and/or prompting a faceto-face (i.e. not just a telephone or electronic communication) evaluation. c Minor bleeding complications: all bleeding complications that are not classified as major or clinically relevant non-major bleeding complication according to the above definitions. d Thromboembolic events: ischaemic stroke, or transient ischaemic attack, or peripheral arterial thromboembolism. ISTH: International Society on Thrombosis and Haemostasis. 6
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