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Items: 1 to 20 of 102

1.

Safety and immunogenicity observations pooled from eight clinical trials of recombinant human thrombin.

Ballard JL, Weaver FA, Singla NK, Chapman WC, Alexander WA.

J Am Coll Surg. 2010 Feb;210(2):199-204. doi: 10.1016/j.jamcollsurg.2009.09.042. Epub 2009 Dec 14.

PMID:
20113940
2.

Safety and immunogenicity of recombinant human thrombin: a pooled analysis of results from 10 clinical trials.

Singla NK, Foster KN, Alexander WA, Pribble JP.

Pharmacotherapy. 2012 Nov;32(11):998-1005. doi: 10.1002/phar.1128. Epub 2012 Oct 26.

PMID:
23108631
3.

Immunogenicity and safety of re-exposure to recombinant human thrombin in surgical hemostasis.

Singla NK, Gasparis AP, Ballard JL, Baron JM, Butine MD, Pribble JP, Alexander WA; RECOTHROM Re-Exposure Study Group.

J Am Coll Surg. 2011 Dec;213(6):722-7. doi: 10.1016/j.jamcollsurg.2011.08.019. Epub 2011 Sep 29.

PMID:
21958507
4.

A phase 3b, open-label, single-group immunogenicity and safety study of topical recombinant thrombin in surgical hemostasis.

Singla NK, Ballard JL, Moneta G, Randleman CD Jr, Renkens KL, Alexander WA.

J Am Coll Surg. 2009 Jul;209(1):68-74. doi: 10.1016/j.jamcollsurg.2009.03.016. Epub 2009 May 28.

PMID:
19651065
5.

Recombinant thrombin: safety and immunogenicity in burn wound excision and grafting.

Greenhalgh DG, Gamelli RL, Collins J, Sood R, Mozingo DW, Gray TE, Alexander WA.

J Burn Care Res. 2009 May-Jun;30(3):371-9. doi: 10.1097/BCR.0b013e3181a28979.

PMID:
19349898
6.

Recombinant human thrombin: safety and immunogenicity in pediatric burn wound excision.

Foster KN, Mullins RF, Greenhalgh DG, Gamelli RL, Glat P, Lentz CW, Kahn SA, Brandigi C, Fredlund P, Alexander WA.

J Pediatr Surg. 2011 Oct;46(10):1992-9. doi: 10.1016/j.jpedsurg.2011.05.022.

PMID:
22008340
7.

A comparison of recombinant thrombin to bovine thrombin as a hemostatic ancillary in patients undergoing peripheral arterial bypass and arteriovenous graft procedures.

Weaver FA, Lew W, Granke K, Yonehiro L, Delange B, Alexander WA; Study Investigators.

J Vasc Surg. 2008 Jun;47(6):1266-73. doi: 10.1016/j.jvs.2008.01.034. Epub 2008 Apr 28.

8.

A safety review of topical bovine thrombin-induced generation of antibodies to bovine proteins.

Ofosu FA, Crean S, Reynolds MW.

Clin Ther. 2009 Apr;31(4):679-91. doi: 10.1016/j.clinthera.2009.04.021. Review.

PMID:
19446142
9.

Persistence of antibodies to the topical hemostat bovine thrombin.

Randleman CD Jr, Singla NK, Renkens KL, Souza S, Pribble JP, Alexander WA.

J Am Coll Surg. 2010 Dec;211(6):798-803. doi: 10.1016/j.jamcollsurg.2010.07.023. Epub 2010 Oct 25.

PMID:
20980172
10.

A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis.

Chapman WC, Singla N, Genyk Y, McNeil JW, Renkens KL Jr, Reynolds TC, Murphy A, Weaver FA.

J Am Coll Surg. 2007 Aug;205(2):256-65. Epub 2007 Jun 27.

PMID:
17660072
11.

A review of three stand-alone topical thrombins for surgical hemostasis.

Cheng CM, Meyer-Massetti C, Kayser SR.

Clin Ther. 2009 Jan;31(1):32-41. doi: 10.1016/j.clinthera.2009.01.005. Review.

PMID:
19243705
12.

Topical recombinant human thrombin in surgical hemostasis.

Bowman LJ, Anderson CD, Chapman WC.

Semin Thromb Hemost. 2010 Jul;36(5):477-84. doi: 10.1055/s-0030-1255441. Epub 2010 Jul 14. Review.

PMID:
20632245
13.

Randomized trial of a dry-powder, fibrin sealant in vascular procedures.

Gupta N, Chetter I, Hayes P, O-Yurvati AH, Moneta GL, Shenoy S, Pribble JP, Zuckerman LA.

J Vasc Surg. 2015 Nov;62(5):1288-95. doi: 10.1016/j.jvs.2015.05.038. Epub 2015 Aug 5.

14.

Safety and efficacy of a novel, dry powder fibrin sealant for hemostasis in hepatic resection.

Ruitenbeek K, Ayez N, Verhoef C, de Wilt JH, Bottema J, Rijken AM, van Rij M, Koopman J, Zuckerman LA, Frohna P, Porte RJ.

Dig Surg. 2014;31(6):422-7. doi: 10.1159/000370006. Epub 2015 Jan 14.

PMID:
25592001
15.

Perioperative topical bovine thrombin exposure is not associated with hemodialysis graft thrombosis.

Vannorsdall MD, Arkel YS, Ku DH, Lucas FL, Himmelfarb J.

Kidney Int. 2003 Aug;64(2):690-6.

16.

Immune-mediated coagulopathy associated with topical bovine thrombin: review of the pediatric literature.

Rodgers GM.

J Pediatr Hematol Oncol. 2011 Mar;33(2):86-8. doi: 10.1097/MPH.0b013e3181ff0e43. Review.

PMID:
21228719
17.

Preclinical safety of recombinant human thrombin.

Heffernan JK, Ponce RA, Zuckerman LA, Volpone JP, Visich J, Giste EE, Jenkins N, Boster D, Pederson S, Knitter G, Palmer T, Wills M, Early RJ, Rogge MC.

Regul Toxicol Pharmacol. 2007 Feb;47(1):48-58. Epub 2006 Sep 12.

PMID:
16971028
18.

Fibrocaps for surgical hemostasis: two randomized, controlled phase II trials.

Verhoef C, Singla N, Moneta G, Muir W, Rijken A, Lockstadt H, de Wilt JH, O-Yurvati A, Zuckerman LA, Frohna P, Porte RJ.

J Surg Res. 2015 Apr;194(2):679-87. doi: 10.1016/j.jss.2014.12.011. Epub 2014 Dec 10.

PMID:
25586331
19.

Immunologic impact and clinical outcomes after surgical exposure to bovine thrombin.

Ortel TL, Mercer MC, Thames EH, Moore KD, Lawson JH.

Ann Surg. 2001 Jan;233(1):88-96.

20.

Topical bovine thrombin and adverse events: a review of the literature.

Clark J, Crean S, Reynolds MW.

Curr Med Res Opin. 2008 Jul;24(7):2071-87. doi: 10.1185/03007990802186417 . Epub 2008 Jun 11. Review.

PMID:
18549663

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