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Recombinant activated coagulation factor VII (rFVIIa) as an adjunctive hemostatic therapy in patients with multiple system organ failure and acute upper gastrointestinal bleeding

Major upper gastrointestinal bleeding leads to increased length of stay and increased risk of death among critically ill patients [1]. Despite recent developments in prophylaxis, large randomized trials have not shown a decrease in mortality. Patients with multiple system organ failure (MSOF) accompanied by coagulopathy are among those with high risk for clinically important major gastrointestinal bleeding. The combination of increased risk of gastrointestinal lesions and coagulopathy makes this population of critically ill extremely vulnerable once the bleeding begins. Recombinant activated factor VII (NovoSeven®; Novo Nordisk, Denmark) has recently been used to reduce bleeding complications and to control bleeding in hemophilic patients [2], and also in cases of intractable postsurgical intra-abdominal hemorrhage and traumatic bleeding. Fifteen surgical and nonsurgical patients with clinically significant gastrointestinal bleeding and MSOF (Simplified Acute Physiology Score II between 53 and 69 points) were enrolled in this study. All patients had different types and degrees of coagulation abnormalities before the bleeding episode as a part of their MSOF. After the onset of bleeding all patients required fluid resuscitation, red blood cell transfusion, fresh frozen plasma and platelet concentrates, and in 73% we used inotropes and pressors to support the failing circulation. The initial bleeding rate among patients was between 14 and 22 ml/min. After the bleeding was considered clinically significant we used a single standard intravenous dose of rFVIIa along with other standard accepted therapeutic measures, including endoscopy. Bleeding decreased after this first dose of rFVIIa and ceased within a period of 18–110 min, with progressive return of coagulation parameters to near pre-bleeding values. Four patients required a second dose of rFVIIa. There were no thromboembolic adverse effects and recurrent episodes of bleeding within the first 5 days after the bleeding episode. We concluded the successful use of rFVIIa in patients with MSOF and acute upper gastrointestinal bleeding, when this hemostatic agent could compensate for MSOF-related coagulation abnormalities. Further large studies are needed to assess the efficacy of rFVIIa use and its relationship with possible decreased transfusion requirements in such patients.


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Milanov, S., Milanov, M., Gyurov, E. et al. Recombinant activated coagulation factor VII (rFVIIa) as an adjunctive hemostatic therapy in patients with multiple system organ failure and acute upper gastrointestinal bleeding. Crit Care 7, P104 (2003).

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  • Gastrointestinal Bleeding
  • Bleeding Episode
  • Coagulation Abnormality
  • Progressive Return
  • Hemophilic Patient