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4. Eighty-two (36%) patients had at least one ECMO-related major bleeding event (oro-nasal bleeding 10%; hemothorax 7%; cerebral bleeding 7%), which was less frequent with patients alive at 6-months.
A major bleeding event was assumed to occur on day 5 of the hospital stay and prophylaxis is stopped immediately.
The primary outcome measure will be the proportion of patients experiencing a major bleeding event in the 90 days after discharge.
The primary outcome measure will be the proportion of patients experiencing a major bleeding event in the 90 days after hospital discharge.
Because of immediate prophylaxis withdrawal in the case of a pre-discharge VTE or major bleeding event, there is no further prophylactic drug consumption after discharge from hospital.
In the case of a prophylaxis-related major bleeding event during the initial treatment period, it is assumed to occur on day 5 of the hospital stay [ 27] and prophylaxis is stopped immediately.
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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.
In a VKA suitable cohort of 1000 patients with NVAF, compared with warfarin, the use of apixaban resulted in 24 fewer strokes (including first and recurrent ischemic and hemorrhagic) or systemic embolism, 41 fewer major bleeding events (including first and recurrent hemorrhagic stroke, other intracranial hemorrhage and other major bleeds), and 26 fewer cardiovascular-related deaths (Table 5).
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