Recombinant activated factor VII increases survival time in a model of incompressible arterial hemorrhage in the anesthetized pig

Journal of Trauma - Injury, Infection and Critical Care

Volumn 62, Issue 4, 2007, Pages 868-879

  Sapsford, Wayne ^a   Watts, Sarah ^a   Cooper, Graham ^a   Kirkman, Emrys ^a,b  

^a DEFENCE SCIENCE AND TECHNOLOGY LABORATORY   (United Kingdom)

^b Biomedical Sciences   (United Kingdom)

Author keywords

Hemorrhage; Recombinant activated factor VII; Resuscitation; rFVIIa; Survival

Indexed keywords

PLACEBO; RECOMBINANT BLOOD CLOTTING FACTOR 7A;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; AORTA; ARTERIAL PRESSURE; ARTICLE; BLEEDING; BLOOD PRESSURE; BLOOD VOLUME; CONFIDENCE INTERVAL; CONTROLLED STUDY; HYPOTENSION; LOG RANK TEST; NONHUMAN; PRIORITY JOURNAL; RESUSCITATION; SURVIVAL TIME; SWINE; SYSTOLIC BLOOD PRESSURE;

ANIMALS; DISEASE MODELS, ANIMAL; FACTOR VII; FLUID THERAPY; HEMORRHAGE; HEMOSTATIC TECHNIQUES; HYPOTENSION; PROTHROMBIN TIME; RANDOM ALLOCATION; RECOMBINANT PROTEINS; SURVIVAL; SWINE; WOUNDS AND INJURIES;

EID: 34247195073     PISSN: 00225282     EISSN: 15298809     Source Type: Journal    
DOI: 10.1097/ta.0b013e318034204b     Document Type: Article

References (49)

1. Champion HR, Bellamy RF, Roberts CP, Leppaniemi A. A profile of combat injury. J Trauma. 2003;54:S13-S19.
2. Sauaia A, Moore FA, Moore EE, et al. Epidemiology of trauma deaths: a reassessment. J Trauma. 1995;38:185-193.
3. Pusateri AE, Holcomb JB, Kheirabadi BS, Alam HB, Wade CE, Ryan KL. Making sense of the preclinical literature on advanced hemostatic products. J Trauma. 2006;60:674-682.
4. King RB, Filips D, Blitz S, Logsetty S. Evaluation of possible tourniquet systems for use in the Canadian Forces. J Trauma. 2006;60:1061-1071.
5. Walters TJ, Wenke JC, Kauvar DS, McManus JG, Holcomb JB, Baer DG. Effectiveness of self-applied tourniquets in human volunteers. Prehosp Emerg Care. 2005;9:416-422.
6. Pusateri AE, McCarthy SJ, Gregory KW, et al. Effect of a chitosan-based hemostatic dressing on blood loss and survival in a model of severe venous hemorrhage and hepatic injury in swine. J Trauma. 2003;54:177-182.
7. Wedmore I, McManus JG, Pusateri AE, Holcomb JB. A special report on the chitosan-based hemostatic dressing: experience in current combat operations. J Trauma. 2006;60:655-658.
8. Neuffer MC, McDivitt J, Rose D, King K, Cloonan CC, Vayer JS. Hemostatic dressings for the first responder: a review. Mil Med. 2004;169:716-720.
9. Pusateri AE, Delgado AV, Dick EJ Jr, Martinez RS, Holcomb JB, Ryan KL. Application of a granular mineral-based hemostatic agent (QuikClot) to reduce blood loss after grade V liver injury in swine. J Trauma. 2004;57:555-562.
10. Alam HB, Chen Z, Jaskille A, et al. Application of a zeolite hemostatic agent achieves 100% survival in a lethal model of complex groin injury in swine. J Trauma. 2004;56:974-983.
11. Alam HB, Burris D, DaCorta JA, Rhee P. Hemorrhage control in the battlefield: role of new hemostatic agents. Mil Med. 2005;170:63-69.
12. Hedner U. Mechanism of action, development and clinical experience of recombinant FVIIa. J Biotechnol. 2006;124:747-757.
13. Kenet G, Walden R, Eldad A, Martinowitz U. Treatment of traumatic bleeding with recombinant factor VIIa. Lancet. 1999;354:1879.
14. Dutton RP, McCunn M, Hyder M, et al. Factor VIIa for correction of traumatic coagulopathy. J Trauma. 2004;57:709-718.
15. Martinowitz U, Kenet G, Segal E, et al. Recombinant activated factor VII for adjunctive hemorrhage control in trauma. J Trauma. 2001;51:431-438.
16. O'Neill PA, Bluth M, Gloster ES, et al. Successful use of recombinant activated factor VII for trauma-associated hemorrhage in a patient without pre-existing coagulopathy. J Trauma. 2002;52:400-405.
17. Clark AD, Gordon WC, Walker ID, Tait RC. 'Last-ditch' use of recombinant factor VIIa in patients with massive haemorrhage is ineffective. Vox Sang. 2004;86:120-124.
18. Martinowitz U, Michaelson M. Guidelines for the use of recombinant activated factor VII (rFVIIa) in uncontrolled bleeding: a report by the Israeli Multidisciplinary rFVIIa Task Force. J Thromb Haemost. 2005;3:640-648.
19. Biss TT, Hanley JP. Recombinant activated factor VII (rFVIIa/NovoSeven) in intractable haemorrhage: use of a clinical scoring system to predict outcome. Vox Sang. 2006;90:45-52.
20. Harrison TD, Laskosky J, Jazaeri O, Pasquale MD, Cipolle M. "Low-dose" recombinant activated factor VII results in less blood and blood product use in traumatic hemorrhage. J Trauma. 2005;59:150-154.
21. Boffard KD, Riou B, Warren B, et al. 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.
22. Jeroukhimov I, Jewelewicz D, Zaias J, et al. Early injection of highdose recombinant factor VIIa decreases blood loss and prolongs time from injury to death in experimental liver injury. J Trauma. 2002;53:1053-1057.
23. 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.
24. Lynn M, Jerokhimov I, Jewelewicz D, et al. Early use of recombinant factor VIIa improves mean arterial pressure and may potentially decrease mortality in experimental hemorrhagic shock: a pilot study. J Trauma. 2002;52:703-707.
25. 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.
26. Pusateri AE, Ryan KL, Delgado AV, et al. Effects of increasing doses of activated recombinant factor VII on haemostatic parameters in swine. Thromb Haemost. 2005;93:275-283.
27. 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.
28. Schreiber MA, Holcomb JB, Hedner U, et al. The effect of recombinant factor VIIa on noncoagulopathic pigs with grade V liver injuries. J Am Coll Surg. 2003;196:691-697.
29. Sondeen JL, Pusateri AE, Hedner U, Yantis LD, Holcomb JB. Recombinant factor VIIa increases the pressure at which rebleeding occurs in porcine uncontrolled aortic hemorrhage model. Shock. 2004;22:163-168.
30. Bickell WH, Wall MJ, Pepe PE, et al. Immediate versus delayed fluid resuscitation for hypotensive patients with penetrating torso injuries. New Engl J Med. 1994;331:1105-1109.
31. Defence Medical Education and Training Agency. Battlefield Advanced Life Support. UK: Defence Medical Education and Training Agency, 2006.
32. Parry C, Garner J, Bird J, Watts S, Kirkman E. Reduced survival time with prolonged hypotensive versus normotensive resuscitation. [Abstract] Brit J Surg. 2005;92(Suppl 1):112.
33. Rafie AD, Rath PA, Michell MW, et al. Hypotensive resuscitation of multiple hemorrhages using crystalloid and colloids. Shock. 2004;22:262-269.
34. National Institute for Clinical Excellence. Pre-hospital initiation of fluid replacement therapy in trauma. Technology Appraisal 74. UK: NHS National Institute for Clinical Excellence, 2004.
35. Committee on Trauma ACoS. Advanced Trauma Life Support (ATLS) Course for Physicians. Chicago: American College of Surgeons, 2002.
36. Bush JA, Jensen WN, Cartwright GE, Wintrobe MM. Blood volume studies in normal and anemic swine. Am J Physiol. 1955;181:14.
37. Stern SA, Dronen SC, Birrer P, Wang X. Effect of blood-pressure on hemorrhage volume and survival in a near-fatal hemorrhage model incorporating a vascular injury. Ann Emerg Med. 1993;22:155-163.
38. Bancroft SD, Stevens A. Theory and Practice of Histological Techniques. Edinburgh: Churchill Livingstone, 1982.
39. Brown MB, Forsythe AB. Robust tests for the equality of variances. J Am Stat Assoc. 1974;69:364-367.
40. Armitage P, Berry G. Statistical Methods in Medical Research. Oxford: Blackwell, 1994.
41. Lawless JF. Statistical Models and Methods for Lifetime Data. New York: Wiley, 1982.
42. Siegel S. Non Parametric Statistics. New York: Mc Graw Hill, 1956.
43. Champion HR. Combat fluid resuscitation: introduction and overview of conferences. J Trauma. 2003;54:S7-S12.
44. Bohman HR, Stevens RA, Baker BC, Chambers LW. The US Navy's forward resuscitative surgery system during operation Iraqi freedom. Mil Med. 2005;170:297-301.
45. Krausz MM. Fluid resuscitation strategies in the Israeli army. J Trauma. 2003;54:S39-S42.
46. Bilski TR, Baker BC, Grove JR, et al. Battlefield casualties treated at Camp Rhino, Afghanistan: lessons learned. J Trauma. 2003;54:814-821.
47. Meng ZH, Wolberg AS, Monroe DM, Hoffman M. The effect of temperature and pH on the activity of factor VIIa: implications for the efficacy of high-dose factor VIIa in hypothermic and acidotic patients. J Trauma. 2003;55:886-891.
48. Mayo A, Misgav M, Kluger Y, et al. Recombinant activated factor VII (NovoSeven): addition to replacement therapy in acute, uncontrolled and life-threatening bleeding. Vox Sang. 2004;87:34-40.
49. Geeraedts LM Jr, Kamphuisen PW, Kaasjager HA, Verwiel JM, van Vugt AB, Frolke JP. The role of recombinant factor VIIa in the treatment of life-threatening haemorrhage in blunt trauma. Injury. 2005;36:495-500.