Safety and efficacy of a single bolus administration of recombinant factor VIIa in liver transplantation due to chronic liver disease

Liver Transplantation

Volumn 11, Issue 8, 2005, Pages 895-900

  Planinsic, Raymond M ^a   van der Meer, Jan ^b   Testa, Giuliano ^c   Grande, Luis ^d   Candela, Angel ^e   Porte, Robert J ^b   Ghobrial, R Mark ^f   Isoniemi, Helena ^g   Schelde, Peter Billeskov ^h   Erhardtsen, Elisabeth ^h   Klintmalm, Goran ⁱ   Emre, Sukru ^j,k  

^a UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

^b UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^c UNIVERSITY HOSPITAL ESSEN   (Germany)

^d HOSPITAL CLÍNIC   (Spain)

^e HOSPITAL RAMÓN Y CAJAL   (Spain)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^h NOVO NORDISK A S   (Denmark)

ⁱ BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^j MOUNT SINAI MEDICAL CENTER   (United States)

^k MOUNT SINAI SCHOOL OF MEDICINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; RECOMBINANT BLOOD CLOTTING FACTOR 7A;

ABDOMINAL BLEEDING; ACIDOSIS; ANEMIA; ANURIA; ARTICLE; ASCITES; BILE DUCT CARCINOMA; BLEEDING; BOLUS INJECTION; CHRONIC LIVER DISEASE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVULSION; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FATALITY; DRUG MECHANISM; DRUG SAFETY; DYSPNEA; ERYTHROCYTE TRANSFUSION; FEMALE; FEVER; HEART FAILURE; HEART INFARCTION; HEMATEMESIS; HEMOSTASIS; HUMAN; HYPERGLYCEMIA; KIDNEY DYSFUNCTION; KIDNEY FAILURE; LIVER FAILURE; LIVER TRANSPLANTATION; LUNG INSUFFICIENCY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PLEURA EFFUSION; PREOPERATIVE CARE; PRIORITY JOURNAL; PROTHROMBIN TIME; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SEPSIS; SINGLE DRUG DOSE; THROMBOEMBOLISM; THROMBOPHLEBITIS;

ADULT; CHRONIC DISEASE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; ERYTHROCYTE TRANSFUSION; FACTOR VII; FEMALE; HEMORRHAGE; HUMANS; LIVER FAILURE; LIVER TRANSPLANTATION; MALE; MIDDLE AGED; PREOPERATIVE CARE; RECOMBINANT PROTEINS; TREATMENT OUTCOME;

EID: 23744438763     PISSN: 15276465     EISSN: None     Source Type: Journal    
DOI: 10.1002/lt.20458     Document Type: Article

References (24)

1. Mor E, Jennings L, Gonwa TA, Holman MJ, Gibbs J, Solomon H, et al. The impact of operative bleeding on outcome in transplantation of the liver. Surg Gynecol Obstet 1993;176:219-227.
2. Palomo Sanchez JC, Jimenez C, Moreno Gonzalez E, Garcia I, Palma F, Loinaz C, Gonzalez Ghamorro A. Effects of intraoperative blood transfusion on postoperative complications and survival after orthotopic liver transplantation. Hepatogastroenterology 1998;45:1026-1033.
3. Porte RJ, Knot EA, Bontempo FA. Hemostasis in liver transplantation. Gastroenterology 1989;97:488-501.
4. Schroeder RA, Johnson LB, Plotkin JS, Kuo PC, Klein AS. Total blood transfusion and mortality after orthotopic liver transplantation [letter]. Anesthesiology 1999;91:329-330.
5. Spahn DR, Casutt M. Eliminating blood transfusions. Anesthesiology 2000;93:242-255.
6. Cacciarelli TV, Keeffe EB, Moore DH, Burns W, Busque S, Concepcion W, et al. Effect of intraoperative blood transfusion on subject outcome in hepatic transplantation. Arch Surg 1999;134:25-29.
7. Porte RF, Molenaar IQ, Begliomini B, Groenland THN, Januszkiewicz A, Lindgren L, et al. Aprotinin and transfusion requirements in orthotopic liver transplantation: A multicentre randomised double-blind study. Lancet 2000;355:1303-1309.
8. Porte RJ, Leebeek FWG. Pharmacological strategies to decrease transfusion requirements in patients undergoing surgery. Drugs 2002;62:2193-2211.
9. Garcia-Huete L, Domenech P, Sabate A, Martinez-Brotons F, Jaurrieta E, Figueras J. The prophylactic effect of aprotinin on intraoperative bleeding in liver transplantation: A randomized clinical study. Hepatology 1997;26:1143-1148.
10. Porte RJ, Molenaar IQ. Aprotinin in liver transplantation. Hepatology 1998;27:1169-1171.
11. Molenaar IQ, Legnani C, Groenland TH, Palareti G, Begliomini B, Terpstra OT, Porte RJ. Aprotinin in orthotopic liver transplantation: Evidence for a prohemostatic, but not a prothrombotic, effect. Liver Transpl 2001;7:896-903.
12. Ramsay MAE, Randall HB, Burton EC. Intravascular thrombosis and thromboembolism during liver transplantation: antifibrinolytic therapy implicated? Liver Transpl 2004;10:310-314.
13. Boffard KD, Warren B, Iau P. Decreased transfusion utilization and improved outcome associated with the use of recombinant factor VIIa as an adjunct in trauma [abstract]. J Trauma 2004; 57:451.
14. Bosch J, Thabut D, Bendtsen F, D'Amico G, Albillos A, Gonzalez Abraldes J, et al; European Study Group on rFVIIa in UGI Haemorrhage. Recombinant factor VIIa for upper gastrointestinal bleeding in patients with cirrhosis: A randomized, double-blind trial. Gastroenterology 2004;127:1123-1130.
15. Lodge JPA, Jonas S, Oussoultzoglou E, Malago M, Jayr C, Cherqui D, et al. Recombinant coagulation factor VIIa in major liver resection: a randomized, placebo-controlled, double-blind clinical trial. Anesthesiology 2005;102:269-275.
16. Hendriks HGD, Meijer K, de Wolf JTM, Klompmaker IJ, Porte RJ, de Kam PJ, et al. Reduced transfusion requirements by recombinant factor VIIa in orthotopic liver transplantation: A pilot study. Transplantation 2001;71:402-405.
17. Meijer K, Hendriks HG, De Wolf JT, Klompmaker IJ, Lisman T, Hagenaars AA, et al. Recombinant factor VIIa in orthotopic liver transplantation: Influence on parameters of coagulation and fibrinolysis. Blood Coagul Fibrinolysis 2003;14:169-174.
18. Hoffman M, Monroe DM III. A cell-based model of hemostasis. Thromb Haemost 2001;85:958-965.
19. 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.
20. Monroe DM, Hoffman M, Oliver JA, Roberts HR. A possible mechanism of action of activated factor VII independent of tissue factor. Blood Coagul Fibrinolysis 1998;9(Suppl 1):S15-S20.
21. Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg 1973;60:646-649.
22. Hollander M, Wolfe DA. Nonparametric Statistical Methods. New York, NY: John Wiley & Sons; 1973. pp. 120-123.
23. Villar A, Aronis S, Morfini M, Santagostino E, Auerswald G, Thomsen HF, et al. Pharmacokinetics of activated recombinant coagulation factor VII (Novo Seven) in children vs. adults with haemophilia A. Haemophilia 2004;10:352-359.
24. Porte RJ. Antifibrinolytics in liver transplantation: They are effective, but what about the risk-benefit ratio? Liver Transpl 2004;10:285-288.