Safety outcomes
The 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 andcould be related (at least possibly) to the study and were
medically significant or had serious sequelae for the patient.