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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Pharmacokinetics of recombinant activated factor VII in trauma patients with severe bleeding
Critical Care, Volume 10, No. 4, Article 104, Year 2006
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Description
Introduction: Recombinant activated factor VII (rFVIIa) has been used as adjunctive therapy in trauma patients with severe bleeding. However, its pharmacokinetics profile remains unknown. Methods: In two placebo-controlled studies in patients with blunt and penetrating trauma, the pharmacokinetics of rFVIIa given at an initial dose of 200 μg.kg-1 after transfusion of eight red blood cell units, followed by additional doses of 100 μg.kg-1, one and three hours later, have been studied, based on the FVII coagulant activity assay. Both non-compartment and population pharmacokinetic analyses were performed. A two-compartment, population pharmacokinetic model was used to estimate a population profile for the rFVIIa dosing regimen. Data are population means (percent coefficient of variation (CV)). Results: Based on the two-compartment population model, the estimated pharmacokinetic parameters were: clearance 40 (30% CV) ml.kg-1.h-1; central volume of distribution 89 (32% CV) ml.kg-1; inter-compartmental clearance 24 ml.kg-1.h-1; and peripheral compartment volume 31 ml.kg-1. Baseline FVII coagulant activity was estimated at 0.29 (39% CV) U.ml-1, initial half-life was 0.6 (34% CV) hours, and terminal half-life 2.4 (50% CV) hours. High intra- and inter-patient variability was noted in volume of distribution and clearance, which was in part correlated with the transfusion requirements as the single significant covariate. The non-compartmental analysis led to almost identical estimates of key parameters. Conclusion: A high intra- and inter-patient variability was noted in the volume of distribution and clearance of rFVIIa in trauma patients with severe bleeding, mainly related with the transfusion requirements and thus blood loss and/or bleeding rate. © 2006 Klitgaard et al.; licensee BioMed Central Ltd.
Authors & Co-Authors
Klitgaard, Thomas
Denmark, Bagsvard
Novo Nordisk A/s
Palacios, Rene Tabanera
Denmark, Bagsvard
Novo Nordisk A/s
Boffard, Kenneth D.
South Africa, Johannesburg
Charlotte Maxeke Johannesburg Academic Hospital
Iau, Phillip Tsau Choong
Singapore, Singapore City
National University Hospital
Warren, Brian Leigh
South Africa, Tygerberg
Tygerberg Hospital
Rizoli, Sandro Baleotti
Canada, Toronto
University of Toronto
Rossaint, Rolf
Germany, Aachen
Uniklinik Rwth Aachen
Kluger, Yoram S.
Israel, Haifa
Haifa Medical Center Rothschild
Riou, Bruno
France, Paris
Hôpital Universitaire Pitié Salpêtrière
Statistics
Citations: 37
Authors: 9
Affiliations: 8
Identifiers
Doi:
10.1186/cc4977
ISSN:
13648535
e-ISSN:
1466609X
Research Areas
Health System And Policy
Study Design
Cross Sectional Study