Effect of the administration of recombinant activated factor VII (rFVIIa; NovoSeven®) in the management of severe uncontrolled bleeding in patients undergoing heart valve replacement surgery

Douri, M. Al; Shafi, Taimur T.; Khudairi, DhaftrM.Al; Bokhari, E Al; Black, L; Akinwale, N; Musa, Mustaffa; Homaidhi, A. Al; Fagih, Mohamed Al; Andreasen, R. B.

doi:10.1097/00001721-200004001-00023

Cited by 159 publications

(83 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Taken together these studies strongly suggest that the prophylactic use of rFVIIa for all patients under- Bishop et 40 hemorrhage patient died of right ventricular failure. rFVIIa = recombinant activated factor VII.…”

Section: Rationalementioning

confidence: 64%

“…The evidence on rFVIIa in refractory bleeding associated with cardiac surgery is currently limited to observational studies consisting of case reports (not referenced), case series, [27][28][29][30][31][32][33][34][35][36][37][38][39][40] and case-control studies. [41][42][43][44][45] These observational studies have important limitations such as reporting bias in favour of the intervention and inability to fully adjust for the effects of confounding variables.…”

Section: Rationalementioning

confidence: 99%

See 1 more Smart Citation

The role of recombinant factor VIIa in on-pump cardiac surgery: Proceedings of the Canadian Consensus Conference

Karkouti

Beattie

Crowther

et al. 2007

Can J Anesth/J Can Anesth

View full text Add to dashboard Cite

Purpose: Recombinant activated factor VII (rFVIIa) is currently not approved by Health Canada or the Food and Drug Administration for treating excessive blood loss in nonhemophiliac patients undergoing on-pump cardiac surgery, but is increasingly being used "off-label" for this indication. A Canadian Consensus Conference was convened to generate recommendations for rFVIIa use in on-pump cardiac surgery. Methods: The panel undertook a literature review of the use of rFVIIa in both cardiac and non-cardiac surgery. Appropriateness, timing, and dosage considerations were addressed for three cardiac surgery indications: prophylactic, routine, and rescue uses. Recommendations were based on evidence from the literature and derived by consensus following recognized grading procedures. Results: The panel recommended against prophylactic or routine use of rFVIIa, as there is no evidence at this time that the benefits of rFVIIa outweigh its potential risks compared with standard hemostatic therapies. On the other hand, the panel made a weak recommendation (grade 2C) for the use of rFVIIa (one to two doses of 35-70 µg·kg -1 ) as rescue therapy for blood loss that is refractory to standard hemostatic therapies, despite the lack of randomized controlled trial data for this indication. Conclusions: In cardiac surgery, the risks and benefits of rFVIIa are unclear, but current evidence suggests that its benefits may outweigh its risks for rescue therapy in selected patients. Methodologically rigorous studies are needed to clarify its riskbenefit profile in cardiac surgery patients. 200 Elizabeth Street, Toronto, Ontario M5G 2C4,; E-mail: keyvan.karkouti@uhn.on.ca Disclosure statement: Novo Nordisk (Mississauga, Ontario, Canada), the makers of rFVIIa, funded this project through an unrestricted educational grant. Novo Nordisk was not involved in the selection of the members of the consensus panel, nor were they involved in the panel's review process, deliberations, conclusions, or manuscript preparation. The panel's chair selected the panel members, with the objective of achieving relevant multi-disciplinary expertise (i.e., anesthesiology, cardiac surgery, hematology, intensive care, and clinical epidemiology). The manuscript was primarily written by the panel chair (Keyvan Karkouti) and was approved by all of the panel members. All of the authors received an honorarium for attending the consensus conference.

show abstract

Section: Rationalementioning

confidence: 64%

Section: Rationalementioning

confidence: 99%

The role of recombinant factor VIIa in on-pump cardiac surgery: Proceedings of the Canadian Consensus Conference

Karkouti

Beattie

Crowther

et al. 2007

Can J Anesth/J Can Anesth

View full text Add to dashboard Cite

show abstract

“…In addition, it is a useful hemostatic agent proven effective in numerous other diagnostic and therapeutic procedures like biopsies in liver disease, thrombocytopenia with bleeding, total hip replacement, etc. (3,9,10). rFVIIa induces hemostasis at the site of injury independent of the presence of FVIII and by forming complexes with exposed tissue factor (TF) (1).…”

Section: Introductionmentioning

confidence: 99%

Recombinant factor Vlla therapy in a patient on long term anticoagulant treatment with a bleeding and acute subdural hematoma

Kovač

Gopčević

Kovač

et al. 2007

View full text Add to dashboard Cite

In this paper we report on the successful correction of a coagulopathy with activated recombinant factor seven (rFVIIa) therapy which enabled surgical removal of a life threatening subdural hematoma. The severe coagulopathy developed due to long term warfarin therapy, which followed heart valvular reconstruction and replacement. The coagulopathy failed to improve following fresh frozen plasma and vitamin K therapy. Activated recombinant factor VII therapy became the treatment of choice, which enabled the life saving surgical removal of the subdural hematoma.

show abstract

“…6 Recent case reports and small patient series have even presented the compound as a "magic bullet". 7,8 However, this efficacy has not been totally borne out on prophylactic rVIIa use in scheduled surgical patients. In patients undergoing liver transplantation 9 or major orthopedic surgery, 10 no definite conclusion on rVIIa efficacy can yet be drawn.…”

mentioning

confidence: 99%

“…6 De récentes observations et de petites séries ont même présenté le composé comme une «solution magique». 7,8 Mais son efficacité préventive n'a pas été totalement confirmée en chirurgie réglée. Aucune conclusion définitive ne peut être tirée sur son efficacité en cas de greffe du foie 9 ou de chirurgie orthopédique majeure.…”

unclassified

Preemptive use of recombinant activated factor VII: many questions but few answers

Samama

2006

Can J Anesth/J Can Anesth

View full text Add to dashboard Cite

Effect of the administration of recombinant activated factor VII (rFVIIa; NovoSeven®) in the management of severe uncontrolled bleeding in patients undergoing heart valve replacement surgery

Cited by 159 publications

References 5 publications

The role of recombinant factor VIIa in on-pump cardiac surgery: Proceedings of the Canadian Consensus Conference

The role of recombinant factor VIIa in on-pump cardiac surgery: Proceedings of the Canadian Consensus Conference

Recombinant factor Vlla therapy in a patient on long term anticoagulant treatment with a bleeding and acute subdural hematoma

Preemptive use of recombinant activated factor VII: many questions but few answers

Contact Info

Product

Resources

About