A totally recombinant human fibrin sealant

Journal of Surgical Research

Volumn 187, Issue 1, 2014, Pages 334-342

  Carlson, Mark A ^a,c   Calcaterra, Jennifer ^d   Johanning, Jason M ^b,c   Pipinos, Iraklis I ^b,c   Cordes, Crystal M ^a   Velander, William H ^d  

^a UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^b UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^c VA NEBRASKA WESTERN IOWA HEALTH CARE SYSTEM   (United States)

^d UNIVERSITY OF NEBRASKA LINCOLN   (United States)

Author keywords

Factor XIII; Fibrin sealant; Fibrinogen; Hemorrhage; Hemostasis; Human; Recombinant; Swine; Thrombin

Indexed keywords

FACTOR XIII; FIBRIN SEALANT; FIBRINOGEN; HEMORRHAGE; HEMOSTASIS; HUMAN; RECOMBINANT; SWINE; THROMBIN;

ANIMALS; ANIMALS, GENETICALLY MODIFIED; CATTLE; CELLS, CULTURED; DISEASE MODELS, ANIMAL; FACTOR XIIIA; FIBRIN TISSUE ADHESIVE; FIBRINOGEN; HEMORRHAGE; HEMOSTASIS; HUMANS; LACERATIONS; LIVER; MALE; RECOMBINANT PROTEINS; SUS SCROFA; THROMBELASTOGRAPHY; THROMBIN; YEASTS;

EID: 84894079870     PISSN: 00224804     EISSN: 10958673     Source Type: Journal    
DOI: 10.1016/j.jss.2013.09.039     Document Type: Article

References (38)

1. M. Radosevich, H.I. Goubran, and T. Burnouf Fibrin sealant: scientific rationale, production methods, properties, and current clinical use Vox Sang 72 1997 133
2. E.A. Bering Jr. Chemical, clinical, and immunological studies on the products of human plasma fractionation. XX. A development of fibrin foam as a hemostatic agent and for use in conjunction with human thrombin J Clin Invest 23 1944 586
3. R.T.A. Chalmers, R.C. Darling III, and J.T. Wingard et al. Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures Br J Surg 97 2010 1784
4. O. Levy, U. Martinowitz, A. Oran, C. Tauber, and H. Horoszowski The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study J Bone Joint Surg 81 1999 1580
5. J. Rousou, S. Levitsky, and L. Gonzalez-Lavin et al. Randomized clinical trial of fibrin sealant in patients undergoing resternotomy or reoperation after cardiac operations. A multicenter study J Thorac Cardiovasc Surg 97 1989 194
6. C. Moser, I. Opitz, and W. Zhai et al. Autologous fibrin sealant reduces the incidence of prolonged air leak and duration of chest tube drainage after lung volume reduction surgery: a prospective randomized blinded study J Thorac Cardiovasc Surg 136 2008 843
7. P. Rutgeerts, E. Rauws, and P. Wara et al. Randomized trial of single and repeated fibrin glue compared with injection of polidocanol in treatment of bleeding peptic ulcer Lancet 350 1997 692
8. S. Siemer, S. Lahme, and S. Altziebler et al. Efficacy and safety of TachoSil as hemostatic treatment versus standard suturing in kidney tumor resection: a randomized prospective study Eur Urol 52 2007 1156
9. J. Figueras, L. Llado, and M. Miro et al. Application of fibrin glue sealant after hepatectomy does not seem justified: results of a randomized study in 300 patients Ann Surg 245 2007 536
10. J. Briceno, A. Naranjo, and R. Ciria et al. A prospective study of the efficacy of clinical application of a new carrier-bound fibrin sealant after liver resection Arch Surg 145 2010 482
11. D.G. Baer, M.A. Dubick, and J.C. Wenke et al. Combat casualty care research at the U.S. Army Institute of Surgical Research J R Army Med Corps 155 2009 327
12. J.B. Holcomb, A.E. Pusateri, and R.A. Harris et al. Dry fibrin sealant dressings reduce blood loss, resuscitation volume, and improve survival in hypothermic coagulopathic swine with grade V liver injuries J Trauma 47 1999 233
13. M.J. Larson, J.C. Bowersox, R.C. Lim Jr., and J.R. Hess Efficacy of a fibrin hemostatic bandage in controlling hemorrhage from experimental arterial injuries Arch Surg 130 1995 420
14. B.S. Kheirabadi, E.M. Acheson, and R. Deguzman et al. The potential utility of fibrin sealant dressing in repair of vascular injury in swine J Trauma 62 2007 94
15. A.E. Pusateri, H.E. Modrow, and R.A. Harris et al. Advanced hemostatic dressing development program: animal model selection criteria and results of a study of nine hemostatic dressings in a model of severe large venous hemorrhage and hepatic injury in swine J Trauma 55 2003 518
16. A.E. Pusateri, B.S. Kheirabadi, and A.V. Delgado et al. Structural design of the dry fibrin sealant dressing and its impact on the hemostatic efficacy of the product J Biomed Mater Res Part B 70B 2004 114
17. J.B. Holcomb, A.E. Pusateri, and R.A. Harris et al. Effect of dry fibrin sealant dressings versus gauze packing on blood loss in grade V liver injuries in resuscitated swine J Trauma 46 1999 49
18. A.E. Pusateri, J.B. Holcomb, B.S. Kheirabadi, H.B. Alam, C.E. Wade, and K.L. Ryan Making sense of the preclinical literature on advanced hemostatic products J Trauma 60 2006 674
19. M.W. Mosesson Fibrinogen and fibrin structure and functions J Thromb Haemost 3 2005 1894
20. G. Dickneite, H. Metzner, T. Pfeifer, M. Kroez, and G. Witzke A comparison of fibrin sealants in relation to their in vitro and in vivo properties Thromb Res 112 2003 73
21. R.A. Ariens, T.S. Lai, J.W. Weisel, C.S. Greenberg, and P.J. Grant Role of factor XIII in fibrin clot formation and effects of genetic polymorphisms Blood 100 2002 743
22. F.M. Wurm Production of recombinant protein therapeutics in cultivated mammalian cells Nat Biotechnol 22 2004 1393
23. J. Calcaterra, K.E. Van Cott, and S.P. Butler et al. Recombinant human fibrinogen that produces thick fibrin fibers with increased wound adhesion and clot density Biomacromolecules 14 2013 169
24. N.K. Singla, K.N. Foster, W.A. Alexander, and J.P. Pribble Safety and immunogenicity of recombinant human thrombin: a pooled analysis of results from 10 clinical trials Pharmacotherapy 32 2012 998
25. A.E. Lovejoy, T.C. Reynolds, and J.E. Visich et al. Safety and pharmacokinetics of recombinant factor XIII-A2 administration in patients with congenital factor XIII deficiency Blood 108 2006 57
26. J. Neter, W. Wasserman, and M.H. Kutner Applied Linear Statistical Models 3rd ed. 1990 Irwin Publishing Co. Boston
27. D.-S. Park, J.-H. Kim, S.W. Lee, and J.-M. Jeong Secretory expression of the α-subunit of human coagulation factor XIII in the yeast Pichia pastoris Biotechnol Lett 24 2002 97
28. B.J.S.C. Olson, and J. Markwell Assays for determination of protein concentration Curr Protoc Pharmacol Appendix 3 2007 3A
29. W.L. Chandler The thromboelastography and the thromboelastograph technique Semin Thromb Hemost 21 Suppl 4 1995 1
30. J.J. Devlin, S.J. Kircher, and L.F. Littlejohn Swine models of hemorrhagic shock: to splenectomize or not to splenectomize, that is the question J Trauma 67 2009 895
31. G. Dickneite, H. Metzner, and U. Nicolay Prevention of suture hole bleeding using fibrin sealant: benefits of factor XIII J Surg Res 93 2000 201
32. G. Dickneite, H.J. Metzner, M. Kroez, B. Hein, and U. Nicolay The importance of factor XIII as a component of fibrin sealants J Surg Res 107 2002 186
33. K. Foster, D. Greenhalgh, and R.L. Gamelli et al. Efficacy and safety of a fibrin sealant for adherence of autologous skin grafts to burn wounds: results of a phase 3 clinical study J Burn Care Res 29 2008 293
34. G. Silecchia, C.E. Boru, and J. Mouiel et al. The use of fibrin sealant to prevent major complications following laparoscopic gastric bypass: results of a multicenter, randomized trial Surg Endosc 22 2008 2492
35. J.R. Eriksen, T. Bisgaard, S. Assaadzadeh, L.N. Jorgensen, and J. Rosenberg Randomized clinical trial of fibrin sealant versus titanium tacks for mesh fixation in laparoscopic umbilical hernia repair Br J Surg 98 2011 1537
36. J.R. Hess, and J.H. Lawson The coagulopathy of trauma versus disseminated intravascular coagulation J Trauma 60 2006 S12
37. I. Balogh, G. Szoke, and L. Karpati et al. Val34Leu polymorphism of plasma factor XIII: biochemistry and epidemiology in familial thrombophilia Blood 96 2000 2479
38. Tisseel® Kit VH Baxter Fibrin Sealant Prescribing Information. http://www.rxmed.com/b.main/b2.pharmaceutical/b2.prescribe.html. Accessed May 1, 2013.