Preclinical trauma studies of recombinant factor VIIa

doi:10.1186/cc3782

Critical Care
Volume 9
Suppl 5

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Schreiber MA
Holcomb JB
Rojkjaer R

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This article is part of the supplement: Recombinant activated factor VIIa and hemostasis in critical care: a focus on trauma .

Review

Preclinical trauma studies of recombinant factor VIIa

Martin A Schreiber¹ , John B Holcomb² and Rasmus Rojkjaer³

¹Associate Professor of Surgery, Director of Surgical Critical Care, Trauma/Critical Care Section, Oregon Health & Science University, Portland, Oregon, USA

²COL, MC, US Army, Chief, Trauma Division, Trauma Consultant for The Surgeon General Commander, US Army Institute of Surgical Research, Fort Sam Houston, Texas, USA

³Senior Research Director, Hemostasis Discovery, Novo Nordisk Pharmaceuticals Inc., Princeton, New Jersey, USA

author email corresponding author email

Critical Care 2005, 9(Suppl 5):S25-S28doi:10.1186/cc3782


Published:	7 October 2005

Abstract

Preclinical studies in animals and ex vivo human blood have provided a solid rationale for conducting prospective randomized trials in trauma patients. Small animal models have been utilized to study the efficacy of recombinant activated factor VII (rFVIIa; NovoSeven^®) in treating thrombocytopenic rabbits and for the reversal of anticoagulation. Safety models in the rabbit also exist to test for systemic activation of clotting and pathologic thrombosis. Animal models simulating traumatic injuries in humans have primarily been performed in pigs because of species similarities in terms of coagulation characteristics and the larger internal organs. The pig studies, utilizing human rFVIIa, have shown increased strength of clot formation, decreased bleeding, and improved survival. However, these findings are not uniform and are dependant on the model chosen. All of the animal models described have provided good safety data and suggest that the use of rFVIIa is not associated with systemic activation of coagulation or microthrombosis of end organs.