Safety outcomes
Safety outcomes are as follows:
- Number who record major bleeding. Major bleeding is defined as: bleeding that results in death and/or; bleeding that is symptomatic and occurs in a critical area or organ (intra-cranial, intra-spinal, intra-ocular, retroperitoneal, intra-articular, or intramuscular with compartment syndrome) and /or; bleeding that results in a fall in haemoglobin of 20g/L or more, or results in transfusion of two or more units of whole blood or red cells.
- Number who record pulmonary bleeding. Pulmonary bleeding is frank bleeding in the lungs, trachea or bronchi with repeated haemoptysis or requiring repeated suctioning and associated with acute deterioration in respiratory status.
- Number who record epistaxis.
- Number who record HIT. HIT is defined as an unexplained fall in platelet count and a positive heparin antibody test.
- Number who record other adverse events and reactions. Adverse events and reactions are those that, in the site Principal Investigator’s judgement, are not part of the expected clinical course and could be related (at least possibly) to the study and were medically significant or had serious sequelae for the patient.