Primary
Overall mortality (Porta 2008).
In‐hospital mortality from any cause (15‐day and 30‐day).
Bleeding.
Secondary
Incidence of resolution of respiratory failure.
Incidence of resolution of renal failure.
Incidence of resolution of shock (defined as the condition associated with circulatory collapse, when the arterial blood pressure is too low to maintain an adequate supply of blood to the tissues).
Safety.
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Symptoms: DIC score and coagulation/fibrinolysis parameters (aggravation of bleeding).
Death from any cause during treatment or within 28 days after treatment.
Safety.
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Primary: DIC resolution rate (rate of recovery from DIC) as assessed at 7 days after the start of infusion (or withdrawal). Secondary: clinical course of bleeding symptoms and mortality at 28 days after the start of infusion (the disappearance rate of bleeding symptoms at day seven). |
Severity of bleeding (hemorrhagic score).
Packed red cell transfusion requirements.
Platelet concentrate transfusion requirements.
Likely:
Thromboembolic complications (page 123). |
Clinically overt bleeding until hospital discharge (hemorrhagic diathesis).
The type and amount of daily transfusions.
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