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Fourteen percent of patients in the 10K arm compared to 17% in the 20K arm had major bleeding events.
Thrombocytopenia is independently associated with a longer duration of vasopressor and ventilator support and increased major bleeding events, but may not be associated with increased mortality.
Several meta-analyses indicate that in patients undergoing this kind of prophylactic treatment, an important reduction in symptomatic VTE is seen, with no relevant increase in major bleeding events [1, 2, 3, 4, 5].
Major bleeding events were defined as WHO grade 3 and 4. Platelet transfusions were performed using ABO-compatible and leukodepleted concentrates, prepared either from pooled whole-blood donations or from single donor apheresis.
A recent meta-analysis of clinical trials showed that rate of major bleeding events increased with higher doses of aspirin.
No major bleeding events occurred.
Five major bleeding events were noted.
Major bleeding events and clinically relevant non-major bleeding events were defined according to accepted guidelines.
The primary safety outcome was major bleeding events.
The principle toxicity of the treatment was major bleeding events.
All major bleeding events and clinically relevant non-major bleeding events were adjudicated according to the standardised model of bleeding definitions 25 (box 1).
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