RFVIIa and NN1731 reduce bleeding in hydroxyethyl starch hemodiluted rabbits

Journal of Trauma - Injury, Infection and Critical Care

Volumn 69, Issue 5, 2010, Pages 1196-1202

  Lauritzen, Brian ^a   Viuff, Dorthe ^a   Tranholm, Mikael ^a   Ezban, Mirella ^a  

^a NOVO NORDISK A S   (Denmark)

Author keywords

Colloids; FVIIa; HES; Resuscitation; rFVIIa analog; VIIa

Indexed keywords

DRUG ANALOG; HEMOSTATIC AGENT; HETASTARCH; NN 1731; RECOMBINANT BLOOD CLOTTING FACTOR 7A; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BLEEDING; BLEEDING TIME; CONTROLLED STUDY; CUTICLE; DOSE RESPONSE; EX VIVO STUDY; FEMALE; HEMODILUTION; MOLECULAR WEIGHT; NONHUMAN; PRIORITY JOURNAL; RABBIT; THROMBOELASTOGRAPHY;

ANIMALS; BLEEDING TIME; DISEASE MODELS, ANIMAL; DOSE-RESPONSE RELATIONSHIP, DRUG; FACTOR VII; FACTOR VIIA; FEMALE; FOLLOW-UP STUDIES; HEMODILUTION; HEMORRHAGE; HETASTARCH; PLASMA SUBSTITUTES; RABBITS; RECOMBINANT PROTEINS; SPECTROPHOTOMETRY; THROMBELASTOGRAPHY; TREATMENT OUTCOME;

EID: 78549239855     PISSN: 00225282     EISSN: 15298809     Source Type: Journal    
DOI: 10.1097/TA.0b013e3181c6619d     Document Type: Article

References (34)

1. Anderson ID, Woodford M, de Dombal FT, Irving M. Retrospective study of 1000 deaths from injury in England and Wales. BMJ (Clin Res Ed). 1988;296:1305-1308.
2. Sauaia A, Moore FA, Moore EE, et al. Epidemiology of trauma deaths: a reassessment. J Trauma. 1995;38:185-193.
3. Lynn M, Jeroukhimov I, Klein Y, Martinowitz U. Updates in the management of severe coagulopathy in trauma patients. Intensive Care Med. 2002;28(suppl 2):S241-S247.
4. Tieu BH, Holcomb JB, Schreiber MA. Coagulopathy: its pathophysiol-ogy and treatment in the injured patient. World J Surg. 2007;31:1055-1064.
5. Claridge JA, Sawyer RG, Schulman AM, McLemore EC, Young JS. Blood transfusions correlate with infections in trauma patients in a dose-dependent manner. Am Surg. 2002;68:566-572.
6. Moore FA, Moore EE, Sauaia A. Blood transfusion. An independent risk factor for postinjury multiple organ failure. Arch Surg. 1997;132:620-624.
7. Hedner U. Mechanism of action, development and clinical experience of recombinant FVIIa. J Biotechnol. 2006;124:747-757.
8. Monroe DM, Hoffman M, Oliver JA, Roberts HR. Platelet activity of high-dose factor VIIa is independent of tissue factor. Br J Haematol. 1997;99:542-547.
9. Hoffman M. A cell-based model of coagulation and the role of factor VIIa. Blood Rev. 2003;17(suppl 1):S1-S5.
10. Mayer SA, Brun NC, Begtrup K, et al; the Recombinant Activated Factor VII Intracerebral Hemorrhage Trial Investigators. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2005;352:777-785.
11. Mayer SA, Brun NC, Begtrup K, et al; the FAST Trial I. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008;358:2127-2137.
12. Boffard KD, Riou B, Warren B, et al; NovoSeven Trauma Study Group. Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebo-controlled, double-blind clinical trials. J Trauma. 2005;59:8-15.
13. Olsen OH, Persson E. Cofactor-induced and mutational activity enhancement of coagulation factor VIIa. Cell Mol Life Sci. 2008;65:953-963.
14. Moss J, Scharling B, Ezban M, Møller Sørensen T. Evaluation of the safety and pharmacokinetics of a fast-acting recombinant FVIIa analogue, NN1731, in healthy male subjects. J Thromb Haemost. 2009;7: 299-305.
15. Holmberg HL, Lauritzen B, Tranholm M, Ezban M. Faster onset of effect and higher efficacy of NN1731, compared to rFVIIa, aPCC & FVIII in tail-bleeding in haemophilic mice. J Thromb Haemost. 2009; 7:1517-1522.
16. Martinowitz U, Holcomb JB, Pusateri AE, et al. Intravenous rFVIIa administered for hemorrhage control in hypothermic coagulopathic swine with grade V liver injuries. J Trauma. 2001;50:721-729.
17. Schreiber MA, Holcomb JB, Hedner U, Brundage SI, Macaitis JM, Hoots K. The effect of recombinant factor VIIa on coagulopathic pigs with grade V liver injuries. J Trauma. 2002;53:252-257.
18. Klemcke HG, Delgado A, Holcomb JB, et al. Effect of recombinant FVIIa in hypothermic, coagulopathic pigs with liver injuries. J Trauma. 2005;59:155-161.
19. Viuff D, Lauritzen B, Pusateri AE, Andersen S, Rojkjaer R, Johansson PI. Effect of haemodilution, acidosis, and hypothermia on the activity of recombinant factor VIIa (NovoSeven(R)). Br J Anaesth. 2008;101:324-331.
20. Wildgoose P, Nemerson Y, Hansen LL, Nielsen FE, Glazer S, Hedner U. Measurement of basal levels of factor VIIa in hemophilia A and B patients. Blood. 1992;80:25-28.
21. Levi M, Jonge E. Clinical relevance of the effects of plasma expanders on coagulation. Semin Thromb Hemost. 2007;33:810-815.
22. Jamnicki M, Bombeli T, Seifert B, et al. Low-and medium-molecular-weight hydroxyethyl starches: comparison of their effect on blood coagulation. Anesthesiology. 2000;93:1231-1237.
23. Roche AM, James MF, Bennett-Guerrero E, Mythen MG. A head-to-head comparison of the in vitro coagulation effects of saline-based and balanced electrolyte crystalloid and colloid intravenous fluids. Anesth Analg. 2006;102:1274-1279.
24. Von Roten I, Madjdpour C, Frascarolo P, et al. Molar substitution and C2/C6 ratio of hydroxyethyl starch: influence on blood coagulation. Br J Anaesth. 2006;96:455-463.
25. Allen GA, Persson E, Campbell RA, Ezban M, Hedner U, Wolberg AS. A variant of recombinant factor VIIa with enhanced procoagulant and antifibrinolytic activities in an in vitro model of hemophilia. Arterioscler Thromb Vasc Biol. 2007;27:683-689.
26. Sorensen B, Fenger-Eriksen C, Ingerslev J. Recombinant factor VIIa fails to correct coagulopathy induced by haemodilution with colloid. Br J Anaesth. 2005;94:862-863.
27. Martinowitz U, Michaelson M. The Israeli Multidisciplinary rFVIIa Task Force. Guidelines for the use of recombinant activated factor VII (rFVIIa) in uncontrolled bleeding: a report by the Israeli Multidisci-plinary rFVIIa Task Force. J Thromb Haemost. 2005;3:640-648.
28. Lauritzen B, Tranholm M, Ezban M. rFVIIa and a new enhanced rFVIIa-analogue, NN1731, reduce bleeding in clopidogrel-treated and in thrombocytopenic rats. J Thromb Haemost. 2009;7:651-657.
29. Tranholm M, Rojkjaer R, Pyke C, et al. Recombinant factor VIIa reduces bleeding in severely thrombocytopenic rabbits. Thromb Res. 2003;109:217-223.
30. Tranholm M, Kristensen K, Kristensen AT, Pyke C, Røjkjaer R, Persson E. Improved hemostasis with superactive analogs of factor VIIa in a mouse model of hemophilia A. Blood. 2003;102:3615-3620.
31. Lauritzen B, Hedner U, Johansen PB, Tranholm M, Ezban M. Recom-binant human factor VIIa and a factor VIIa-analogue reduces heparin and low molecular weight heparin (LMWH)-induced bleeding in rats. J Thromb Haemost. 2008;6:804-811.
32. Sorensen B, Persson E, Ingerslev J. Factor VIIa analogue (V158D/E296V/M298Q-FVIIa) normalizes clot formation in whole blood from patients with severe haemophilia A. Br J Haematol. 2007;137: 158-165.
33. Brophy DF, Martin EJ, Nolte ME, Kuhn JG, Carr ME Jr. Effect of recombinant factor VIIa variant (NN1731) on platelet function, clot structure and force onset time in whole blood from healthy volunteers and haemophilia patients. Haemophilia. 2007;13:533-541.
34. Petersen LC, Norby PL, Branner S, et al. Characterization of recom-binant murine factor VIIa and recombinant murine tissue factor: a human-murine species compatibility study. Thromb Res. 2005;116: 75-85.