Evidence Supporting the Use of Recombinant Activated Factor VII in Congenital Bleeding Disorders

Johansson, Pär I.; Ostrowski, Sisse Rye

doi:10.17925/eoh.2011.07.01.71

Cited by 2 publications

(2 citation statements)

References 60 publications

(133 reference statements)

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“…For both bypassing agents, the hemostatic responses of patients after treatment are unpredictable due to variability in patient responsiveness. Further, laboratory assays that would be useful for monitoring efficacy or optimizing patient dosing are not yet available [Johansson and Ostrowski, 2010].…”

Section: Safety Of Bypassing Agentsmentioning

confidence: 99%

Advances in bypassing agent therapy for hemophilia patients with inhibitors to close care gaps and improve outcomes

Shapiro

Hedner

2011

Therapeutic Advances in Drug Safety

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In the past, patients with hemophilia and inhibitors have had less-than-optimal treatment and have experienced more orthopedic complications than patients without inhibitors. Bypassing agents offer the potential to close treatment gaps between inhibitor and noninhibitor patients by helping the former better attain key treatment goals, including: facilitating early initiation of treatment and hemostatic control in hemarthroses; providing effective treatment in serious hemorrhagic episodes; and performance of major surgery. Effective treatment with a bypassing agent minimizes joint and/or muscle damage and potentially can serve as an effective prophylactic agent to minimize the number of hemarthroses experienced per year, thereby mitigating the development of arthropathy. The reported efficacy of the currently available bypassing agents ranges from approximately 5080% (5064% in controlled studies) for plasma-derived activated prothrombin complex concentrate (pd-aPCC) and 8191% (in controlled studies) for recombinant activated factor VII (rFVIIa), including use in major orthopedic surgery. Both bypassing agents have undergone key improvements in their formulation and/or properties in recent years. The nanofiltered, vaporheated formulation of pd-aPCC has diminished the risk of acquiring blood-borne viral infections and the room temperature stable formulation of rFVIIa allows more convenient storage, increased ease to dissolve and inject, and smaller volumes, thereby increasing overall ease of administration. Use of recommended dosing has been demonstrated to provide effective hemostasis with a minimal number of injections for both agents. In this paper, we review the individual characteristics of pd-aPCC and rFVIIa and discuss clinical data from studies conducted in inhibitor patients that demonstrate the potential benefits of these bypassing agents in this difficult-to-treat population, and underscore the potential opportunities to close the gap in care between inhibitor and noninhibitor hemophilic patients.

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Section: Safety Of Bypassing Agentsmentioning

confidence: 99%

Advances in bypassing agent therapy for hemophilia patients with inhibitors to close care gaps and improve outcomes

Shapiro

Hedner

2011

Therapeutic Advances in Drug Safety

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“…Recombinant factor VIIa (rFVIIa) acts in pharmacological doses by enhancing thrombin generation on the activated platelets independent of factor VIII and IX and is currently approved for episodes of severe hemorrhage or perioperative management of bleeding in patients with congenital factor VII deficiency and hemophilia A or B with inhibitors [ 103 , 104 ]. Data from the CONTROL trial, a phase 3 randomized clinical trial evaluating efficacy and safety of rFVIIa as an adjunct to direct hemostasis in major trauma [ 105 ], rFVIIa did not change mortality in patients with blunt (11.0% (rFVIIa) vs. 10.7% (placebo)) or penetrating (18.2% (rFVIIa) vs. 13.2% (placebo)) trauma.…”

Section: Hemostatic Agentsmentioning

confidence: 99%

Current management of massive hemorrhage in trauma

Johansson

Stensballe

Ostrowski

2012

Scand J Trauma Resusc Emerg Med

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Hemorrhage remains a major cause of potentially preventable deaths. Trauma and massive transfusion are associated with coagulopathy secondary to tissue injury, hypoperfusion, dilution, and consumption of clotting factors and platelets. Concepts of damage control surgery have evolved prioritizing early control of the cause of bleeding by non-definitive means, while hemostatic control resuscitation seeks early control of coagulopathy.Hemostatic resuscitation provides transfusions with plasma and platelets in addition to red blood cells in an immediate and sustained manner as part of the transfusion protocol for massively bleeding patients. Although early and effective reversal of coagulopathy is documented, the most effective means of preventing coagulopathy of massive transfusion remains debated and randomized controlled studies are lacking.Viscoelastical whole blood assays, like TEG and ROTEM however appear advantageous for identifying coagulopathy in patients with severe hemorrhage as opposed the conventional coagulation assays.In our view, patients with uncontrolled bleeding, regardless of it´s cause, should be treated with hemostatic control resuscitation involving early administration of plasma and platelets and earliest possible goal-directed, based on the results of TEG/ROTEM analysis. The aim of the goal-directed therapy should be to maintain a normal hemostatic competence until surgical hemostasis is achieved, as this appears to be associated with reduced mortality.

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Evidence Supporting the Use of Recombinant Activated Factor VII in Congenital Bleeding Disorders

Cited by 2 publications

References 60 publications

Advances in bypassing agent therapy for hemophilia patients with inhibitors to close care gaps and improve outcomes

Advances in bypassing agent therapy for hemophilia patients with inhibitors to close care gaps and improve outcomes

Current management of massive hemorrhage in trauma

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