Effect of recombinant activated factor VII on perioperative blood loss in patients undergoing retropubic prostatectomy: a double-blind placebo-controlled randomised trial

Friederich, Philip W.; Henny, C. P.; Messelink, E.J.; Geerdink, M; Keller, Tymen; Kurth, K. H.; Büller, Harry R.; Levi, Marcel

doi:10.1016/s0140-6736(03)12268-4

Cited by 402 publications

(225 citation statements)

References 24 publications

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“…Recombinant FVII (rFVIIa) has been demonstrated to potentially stop bleeding in patients with hemophilia, severe thrombocytopenia, and in patients without coagulopathy [17,29]. We have administered rFVIIa into a 17-year-old female who had a refractory ITP and a significant bleeding tendency.…”

Section: Activated Recombinant Fviimentioning

confidence: 99%

Experiences with recombinant FVIIa in the emergency treatment of patients with autoimmune thrombocytopenia: a review of the literature

et al. 2008

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Section: Activated Recombinant Fviimentioning

confidence: 99%

Experiences with recombinant FVIIa in the emergency treatment of patients with autoimmune thrombocytopenia: a review of the literature

et al. 2008

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“…The prophylactic use of rFVIIa in surgery has been assessed by randomized clinical trials (RCTs) in cardiac, 13,14 orthopedic, 15 urologic, 16 and hepatic surgeries, 17-20 with varying results. There are also isolated published 21 and unpublished (personal communication of panel members) reports of its prophylactic use in cardiac surgery.…”

Section: Rationalementioning

confidence: 99%

“…Outside of cardiac surgery, double-blinded RCTs found prophylactic rFVIIa therapy to be effective in urological surgery (n = 36), 16 but not in orthopedic surgery (n = 48), 15 liver resection (n = 204 and 234), 18,19 or liver transplantation (n = 83 and 182). 17,20 In these studies rFVIIa was not associated with thromboembolic complications, but the number of such events was small, limiting the likelihood of finding such differences if they in fact were present.…”

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

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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.

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“…The ability of rFVIIa to effect hemostasis in other clinical settings has also been demonstrated in case reports and clinical trials. [23][24][25][26] In a randomized, controlled trial investigating the safety and efficacy of rFVIIa in patients with upper gastrointestinal bleeding (UGIB) and cirrhosis, there was no significant effect of rFVIIa treatment on the number of 5-day failures in the total population. 8 However, a finding from posthoc analysis was that rFVIIa significantly reduced the number of 5-day failures and improved 24-hour bleeding control in the subgroup of Child-Pugh B and C patients with variceal bleeding, which were the patients with greater impairment of hemostatic parameters.…”

mentioning

confidence: 99%

Recombinant factor VIIa for variceal bleeding in patients with advanced cirrhosis: A randomized, controlled trial

et al. 2008

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on behalf of the International Study Group on rFVIIa in UGI Hemorrhage A beneficial effect of recombinant activated factor VII (rFVIIa) in Child-Pugh class B and C patients with cirrhosis who have variceal bleeding has been suggested. This randomized controlled trial assessed the efficacy and safety of rFVIIa in patients with advanced cirrhosis and active variceal bleeding. At 31 hospitals in an emergency setting, 256 patients (Child-Pugh > 8; Child-Pugh B ‫؍‬ 26%, C ‫؍‬ 74%) were randomized equally to: placebo; 600 g/kg rFVIIa (200 ؉ 4؋ 100 g/kg); or 300 g/kg rFVIIa (200 ؉ 100 g/kg). Dosing was intravenous at 0, 2, 8, 14, and 20 hours after endoscopy, in addition to standard vasoactive, prophylactic antibiotic, and endoscopic treatment. The primary composite endpoint consisted of failure to control 24-hour bleeding, or failure to prevent rebleeding or death at day 5. Secondary endpoints included adverse events and 42-day mortality. Baseline characteristics were comparable between groups. Administration of rFVIIa had no significant effect on the composite endpoint compared with placebo (P ‫؍‬ 0.37). There was no significant difference in 5-day mortality between groups; however, 42-day mortality was significantly lower with 600 g/kg rFVIIa compared with placebo (odds ratio 0.31, 95% confidence interval ‫؍‬ 0.13-0.74), and bleeding-related deaths were reduced from 12% (placebo) to 2% (600 g/kg). A marked heterogeneity in the failure rate in all treatment groups was observed across participating centers. Adverse events, including overall thromboembolic events, were comparable between groups. Conclusion: Treatment with rFVIIa had no significant effect on the primary composite endpoint compared with placebo. Therefore, decision on the use of this hemostatic agent in acute variceal bleeding should be carefully considered, because results of this study do not support the routine use of rFVIIa in this setting. Adverse events were comparable across groups. (HEPATOLOGY 2008;47:1604-1614

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Effect of recombinant activated factor VII on perioperative blood loss in patients undergoing retropubic prostatectomy: a double-blind placebo-controlled randomised trial

Cited by 402 publications

References 24 publications

Experiences with recombinant FVIIa in the emergency treatment of patients with autoimmune thrombocytopenia: a review of the literature

Experiences with recombinant FVIIa in the emergency treatment of patients with autoimmune thrombocytopenia: a review of the literature

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

Recombinant factor VIIa for variceal bleeding in patients with advanced cirrhosis: A randomized, controlled trial

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