Recombinant activated factor VII (NovoSeven<sup>™</sup>): addition to replacement therapy in acute, uncontrolled and life‐threatening bleeding

Mayo, Ann M.; Misgav, Mudi; Kluger, Yoram; Geenberg, R.; Pauzner, David; Klausner, Joseph M.; Ben‐Tal, Ofira

doi:10.1111/j.1423-0410.2004.00533.x

Cited by 70 publications

(74 citation statements)

References 43 publications

(49 reference statements)

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“…This is consistent with the emerging understanding that rFVIIa may be more effective when it is administered early in the course of refractory blood loss in the setting of adequate amounts of circulating coagulation factors. [17][18][19] It may also explain why rFVIIa was not efficacious in existing randomized controlled clinical trials in bleeding patients, many of which did not stipulate the presence of adequate amounts of coagulation factors before rFVIIa therapy.…”

Section: Karkouti Et Al Factor Viia In Cardiac Surgery 335mentioning

confidence: 99%

Comprehensive Canadian Review of the Off-Label Use of Recombinant Activated Factor VII in Cardiac Surgery

et al. 2008

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Background-This observational study sought to identify the off-label use pattern of recombinant activated factor VII (rFVIIa) in cardiac surgery and to identify predictors of its effectiveness and risk. Methods and Results-At 18 Canadian centers, 522 nonhemophiliac cardiac surgical patients received rFVIIa during the period 2003 through 2006; data were available, and retrospectively collected, on 503 patients. The median (quartile 1, quartile 3) units of red blood cells transfused from surgery to therapy and in the 24 hours after therapy were 8 (5, 12) and 2 (1, 5), respectively (PϽ0.0001). Mortality rate was 32%, and mortality or major morbidity rate was 44%. These rates were within expected ranges (mortality, 27% to 35%; mortality or morbidity, 39% to 48%), which were calculated with a separate cohort of cardiac surgical patients who did not receive rFVIIa used as reference. Independent predictors of complications included instability before therapy (multiple inotropes or intra-aortic balloon pump) and increasing red blood cell units transfused before and after therapy. Variables independently associated with nonresponse included abnormal coagulation parameters and Ͼ15 red blood cell units transfused before therapy. Conclusions-In Canada, rFVIIa is used primarily when standard interventions have failed to control bleeding. In this setting, rFVIIa is associated with reduced blood product transfusions and, after risk adjustment, does not appear to be associated with increased or decreased complication rates. The effectiveness of the drug may be enhanced if it is given early in the course of refractory blood loss in the setting of adequate amounts of circulating coagulation factors.

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Section: Karkouti Et Al Factor Viia In Cardiac Surgery 335mentioning

confidence: 99%

Comprehensive Canadian Review of the Off-Label Use of Recombinant Activated Factor VII in Cardiac Surgery

et al. 2008

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“…It is also comparable to the response to rFVIIa reported in life-threatening haemorrhage from all causes, where the median response rate is reported as 74% [2][3][4][5][6][7][8]. There have been no large case series or randomised controlled trials on the use of rFVIIa in obstetric haemorrhage.…”

Section: Discussionmentioning

confidence: 61%

“…Action of rFVIIa is dependant on the presence of adequate numbers of circulating platelets and adequate fibrinogen concentration. Previous reports have shown that the improvements in laboratory markers of DIC, by the administration of blood components prior to the administration of rFVIIa, are associated with a better response to rFVIIa treatment [4]. It is also recognised that Table 4 Guidance for the use of rFVIIa in major obstetric haemorrhage (i) Use of rFVIIa should be considered in major obstetric haemorrhage: -which continues despite optimal blood product replacement and obstetric measures.…”

Section: Discussionmentioning

confidence: 99%

“…However, these 2 patients had additional risk factors (coagulopathy, administration of >10 units of blood, acidosis and hypothermia) prior to rFVIIa administration. All of these risk factors have been shown to be associated with a worse outcome following the administration of rFVIIa [2][3][4][5][6][7][8]. A further 2 patients required vessel embolisation following rFVIIa administration.…”

Section: Discussionmentioning

confidence: 99%

“…In recent years, the off-licence use of rFVIIa as a haemostatic agent in the management of life-threatening haemorrhage in a variety of clinical settings has become well recognised [2][3][4][5][6][7][8]. There are several published case reports and small case series documenting the effective use of rFVIIa in the management of major obstetric haemorrhage [9][10][11][12][13][14][15].…”

Section: Introductionmentioning

confidence: 99%

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Recombinant Activated Factor VII as a Second Line Treatment for Postpartum Hemorrhage

Park

Yeom²,

Han

et al. 2017

Korean J Crit Care Med

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BackgroundSevere or massive postpartum hemorrhage (PPH) has remained a leading cause of maternal mortality for decades across the world and it results in critical obstetric complications. Recombinant activated factor VII (rFVIIa) has emerged as a gold standard adjunctive hemostatic agent for the treatment of life-threatening PPH refractory to conventional therapies although it remains off-licensed for use in PPH. We studied the effects of rFVIIa on coagulopathy, transfusion volume, prognosis, severity change in Korean PPH patients.MethodsA retrospective review of medical records between December 2008 and March 2011 indicating use of rFVIIa in severe PPH was performed. We compared age, rFVIIa treatment, transfusion volume, and Sequential Organ Failure Assessment (SOFA) score at the time of arrival in the emergency department and after 24 hours for patients whose SOFA score was 8 points or higher.ResultsFifteen women with SOFA score of 8 and above participated in this study and eight received rFVIIa administration whereas seven did not. Patients’ mean age was 31.7 ± 7.5 years. There was no statistically significant difference in initial and post-24 hours SOFA scores between patients administered rFVIIa or not. The change in SOFA score between initial presentation and after 24 hours was significantly reduced after rFVIIa administration (P = 0.016).ConclusionsThis analysis aimed to support that the administration of rFVIIa can reduce the severity of life-threatening PPH in patients. A rapid decision regarding the administration of rFVIIa is needed for a more favorable outcome in severe PPH patients for whom there is no effective standard treatment.

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Blood Component Therapy and Massive Transfusion

Hui

Aagaard

Teruya

2018

Critical Care Obstetrics

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Recombinant activated factor VII (NovoSeven^™): addition to replacement therapy in acute, uncontrolled and life‐threatening bleeding

Cited by 70 publications

References 43 publications

Comprehensive Canadian Review of the Off-Label Use of Recombinant Activated Factor VII in Cardiac Surgery

Comprehensive Canadian Review of the Off-Label Use of Recombinant Activated Factor VII in Cardiac Surgery

Recombinant Activated Factor VII as a Second Line Treatment for Postpartum Hemorrhage

Blood Component Therapy and Massive Transfusion

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Recombinant activated factor VII (NovoSeven™): addition to replacement therapy in acute, uncontrolled and life‐threatening bleeding

Cited by 70 publications

References 43 publications

Comprehensive Canadian Review of the Off-Label Use of Recombinant Activated Factor VII in Cardiac Surgery

Comprehensive Canadian Review of the Off-Label Use of Recombinant Activated Factor VII in Cardiac Surgery

Recombinant Activated Factor VII as a Second Line Treatment for Postpartum Hemorrhage

Blood Component Therapy and Massive Transfusion

Contact Info

Product

Resources

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Recombinant activated factor VII (NovoSeven^™): addition to replacement therapy in acute, uncontrolled and life‐threatening bleeding