Prospective, Randomized Clinical Trial of the FloSeal Matrix Sealant in Cardiac Surgery

Annals of Thoracic Surgery

Volumn 88, Issue 5, 2009, Pages 1520-1526

  Nasso, Giuseppe ^a   Piancone, Felice ^a   Bonifazi, Raffaele ^a   Romano, Vito ^a   Visicchio, Giuseppe ^a   De Filippo, Carlo Maria ^b   Impiombato, Barbara ^a   Fiore, Flavio ^a   Bartolomucci, Francesco ^a   Alessandrini, Francesco ^b   Speziale, Giuseppe ^a  

^a Anthea Hospital GVM Care and Research   (Italy)

^b CATHOLIC UNIVERSITY   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

GELATIN; GELATIN SPONGE; HEMOSTATIC AGENT; HEMOSTATIC MATRIX SEALANT; HEPARIN; OXIDIZED REGENERATED CELLULOSE; PROTAMINE SULFATE; SEALANT; THROMBIN; UNCLASSIFIED DRUG; FLOSEAL MATRIX;

ADULT; AGED; ARTICLE; BLEEDING; BLOOD TRANSFUSION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DRUG DOSE TITRATION; FEMALE; HEART SURGERY; HEMOSTASIS; HUMAN; INDUCED HYPOTHERMIA; INTENSIVE CARE UNIT; LENGTH OF STAY; MAJOR CLINICAL STUDY; MALE; MORBIDITY; OUTCOME ASSESSMENT; PEROPERATIVE COMPLICATION; POSTOPERATIVE HEMORRHAGE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SKIN; TREATMENT OUTCOME; COMPARATIVE STUDY; CONTROLLED STUDY; PROSPECTIVE STUDY;

AGED; BLOOD LOSS, SURGICAL; CARDIAC SURGICAL PROCEDURES; FEMALE; GELATIN SPONGE, ABSORBABLE; HEMOSTATICS; HUMANS; MALE; PROSPECTIVE STUDIES;

EID: 70449728019     PISSN: 00034975     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.athoracsur.2009.07.014     Document Type: Article

References (18)

1. Levy J.H., and Despotis G.J. Transfusion and hemostasis in cardiac surgery. Transfusion 48 (2008) 1S
2. Oz M.C., Cosgrove III D.M., Badduke B.R., et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surg 69 (2000) 1376-1382
3. Renkens K.L., Payner T.D., Leipzig T.J., et al. A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. Spine (Phila Pa 1976) 26 (2001) 1645-1650
4. Gazzeri R., Galarza M., Neroni M., Alfieri A., and Esposito F. Minimal craniotomy and matrix hemostatic sealant for the treatment of spontaneous supratentorial intracerebral hemorrhage. J Neurosurg 110 (2009) 939-942
5. Gill I.S., Ramani A.P., Spaliviero M., et al. Improved hemostasis during laparoscopic partial nephrectomy using gelatin matrix thrombin sealant. Urology 65 (2005) 463-466
6. Björses K., and Holst J. Topical haemostatics in renal trauma-an evaluation of four different substances in an experimental setting. J Trauma 66 (2009) 602-611
7. L'Esperance J.O., Sung J.C., Marguet C.G., et al. Controlled survival study of the effects of Tisseel or a combination of FloSeal and Tisseel on major vascular injury and major collecting-system injury during partial nephrectomy in a porcine model. J Endourol 19 (2005) 1114-1121
8. Leixnering M., Reichetseder J., Schultz A., et al. Gelatin thrombin granules for hemostasis in a severe traumatic liver and spleen rupture model in swine. J Trauma 64 (2008) 456-461
9. Izzo F., Di Giacomo R., Falco P., et al. Efficacy of a haemostatic matrix for the management of bleeding in patients undergoing liver resection: results from 237 cases. Curr Med Res Opin 24 (2008) 1011-1015
10. Angioli R., Muzii L., Montera R., et al. Feasibility of use of novel matrix hemostatic sealant (FloSeal) to achieve hemostasis during laparoscopic excision of endometrioma. J Minim Invasive Gynecol 16 (2009) 153-156
11. Guzzo T.J., Pollock R.A., Forney A., Aggarwal P., Matlaga B.R., and Allaf M.E. Safety and efficacy of a surgeon-prepared gelatin hemostatic agent compared with FloSeal for hemostasis in laparoscopic partial nephrectomy. J Endourol 23 (2009) 279-282
12. Lawson J.H. The clinical use and immunologic impact of thrombin in surgery. Semin Thromb Hemost 32 suppl 1 (2006) 98-110
13. Dupont W.D., and Plummer Jr. W.D. Power and sample size calculation for studies involving linear regression. Controlled Clinical Trials 19 (1998) 589-601
14. Levy J.H. Pharmacologic methods to reduce perioperative bleeding. Transfusion 48 (2008) 31S-38S
15. Liu B., Belboul A., Larsson S., and Roberts D. Factors influencing haemostasis and blood transfusion in cardiac surgery. Perfusion 11 (1996) 131-143
16. Despotis G., Eby C., and Lublin D.M. A review of transfusion risk and optimal management of perioperative bleeding with cardiac surgery. Transfusion 48 1 suppl (2008) 2S-30S
17. Whitson B.A., Huddleston S.J., Savik K., and Shumway S.J. Bloodless cardiac surgery is associated with decreased morbidity and mortality. J Card Surg 22 (2007) 373-378
18. Nashef S.A., Roques F., Hammill B.G., et al. Validation of European System for cardiac operative risk evaluation (EuroSCORE) in North American cardiac surgery. Eur J Cardiothorac Surg 22 (2002) 101-105