Recombinant Activated Factor VII in Spinal Surgery

Sachs, Barton L.; Delacy, Dawn; Green, Jeffrey; Graham, Roger A.; Ramsay, James G.; Kreisler, Nevin S.; Kruse, Peter; Khutoryansky, Naum; Hu, Serena S.

doi:10.1097/brs.0b013e3181557d45

Cited by 65 publications

(9 citation statements)

References 32 publications

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“…In patients with trauma and coagulopathy, rFVIIa reduces fresh-frozen plasma transfusions, multiorgan failure, and acute respiratory distress syndrome [18]. Prophylactic use of rFVIIa has been tested in other surgical fields, and several randomized clinical trials have suggested that its use reduces the number of required blood cell transfusions without significantly affecting mortality [19], [20], [21].…”

Section: Discussionmentioning

confidence: 99%

Prophylactic Activated Recombinant Factor VII in Liver Resection and Liver Transplantation: Systematic Review and Meta-Analysis

et al. 2011

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Background and AimIntraoperative blood loss is a frequent complication of hepatic resection and orthotopic liver transplantation. Recombinant activated coagulation factor VII (rFVIIa) is a coagulation protein that induces hemostasis by directly activating factor X. There is no clear information about the prophylactic value of rFVIIa in hepatobiliary surgery, specifically in liver resection and orthotopic liver transplantation. The aim of this study was to assess the effect of rFVIIa prophylaxis to prevent mortality and bleeding resulting from hepatobiliary surgery.MethodsRelevant randomized trials were identified by searching The Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index. Randomized clinical trials comparing different rFVIIa prophylactic schemas against placebo or no intervention to prevent bleeding in hepatobiliary surgery were included. Adults undergoing liver resection, partial hepatectomy, or orthotopic liver transplantation were included. Dichotomous data were analyzed calculating odds ratios (ORs) and 95% confidence intervals (CIs). Continuous data were analyzed calculating mean differences (MD) and 95% CIs.ResultsFour randomized controlled trials were included. There were no significant differences between rFVIIa and placebo for mortality (OR 0.96; 95% CI 0.35–2.62), red blood cell units (MD 0.32; 95% CI −0.08–0.72) or adverse events (OR 1.55; 95% CI 0.97–2.49).ConclusionsThe available information is limited, precluding the ability to draw conclusions regarding bleeding prophylaxis in hepatobiliary surgery using rFVIIa. Although an apparent lack of effect was observed in all outcomes studied, further research is needed.

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Section: Discussionmentioning

confidence: 99%

Prophylactic Activated Recombinant Factor VII in Liver Resection and Liver Transplantation: Systematic Review and Meta-Analysis

et al. 2011

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“…Losses of up to 4.5 liters are well-documented in the literature 1,2, as is the need for transfusion of up to eight units of red blood cell concentrate to support such procedures 3-5.…”

Section: Introductionmentioning

confidence: 99%

Predictive factors for perioperative blood transfusion in surgeries for correction of idiopathic, neuromuscular or congenital scoliosis

Cristante¹,

Borges²,

Barbosa³

et al. 2014

Clinics

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OBJECTIVE:To evaluate the association of clinical and demographic variables in patients requiring blood transfusion during elective surgery to treat scoliosis with the aim of identifying markers predictive of the need for blood transfusion.METHODS:Based on the review of medical charts at a public university hospital, this retrospective study evaluated whether the following variables were associated with the need for red blood cell transfusion (measured by the number of packs used) during scoliosis surgery: scoliotic angle, extent of arthrodesis (number of fused levels), sex of the patient, surgery duration and type of scoliosis (neuromuscular, congenital or idiopathic).RESULTS:Of the 94 patients evaluated in a 55-month period, none required a massive blood transfusion (most patients needed less than two red blood cell packs). The number of packs was not significantly associated with sex or type of scoliosis. The extent of arthrodesis (r = 0.103), surgery duration (r = 0.144) and scoliotic angle (r = 0.004) were weakly correlated with the need for blood transfusion. Linear regression analysis showed an association between the number of spine levels submitted to arthrodesis and the volume of blood used in transfusions (p = 0.001).CONCLUSION:This study did not reveal any evidence of a significant association between the need for red blood cell transfusion and scoliotic angle, sex or surgery duration in scoliosis correction surgery. Submission of more spinal levels to arthrodesis was associated with the use of a greater number of blood packs.

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“…In addition to the RCTs outlined in the previous sections, off-label rFVIIa has also been studied in liver biopsy (Jeffers et al , 2002), prostatectomy (Friederich et al , 2003), pelvic fracture (Raobaikady et al , 2005), haematopoietic stem cell transplant (Pihusch et al , 2005), dengue haemorrhagic fever (Chuansumrit et al , 2005), burn patients requiring surgery (Johansson et al , 2007), spinal fusion surgery (Sachs et al , 2007), traumatic ICH (Narayan et al , 2008) and craniofacial reconstruction (Hanna et al , 2010). All these studies were small with 100 patients or less and only four had more than 50 patients (Jeffers et al , 2002; Pihusch et al , 2005; Sachs et al , 2007; Narayan et al , 2008).…”

Section: Randomised Trials Of Use Of Rfviia In Patients Without Haemomentioning

confidence: 99%

“…All these studies were small with 100 patients or less and only four had more than 50 patients (Jeffers et al , 2002; Pihusch et al , 2005; Sachs et al , 2007; Narayan et al , 2008). No mortality benefit was seen in any of these studies.…”

Section: Randomised Trials Of Use Of Rfviia In Patients Without Haemomentioning

confidence: 99%

“…The recently updated Cochrane systematic review (Table 3) included RCTs of off-label rFVIIa and divided RCTs into prophylactic and therapeutic studies (Simpson et al , 2012). There were 16 prophylactic RCTs where rFVIIa was used to prevent bleeding (Jeffers et al , 2002; Friederich et al , 2003; Diprose et al , 2005; Lodge et al , 2005a,b; Planinsic et al , 2005; Raobaikady et al , 2005; Ekert et al , 2006; Ma et al , 2006; Shao et al , 2006; Essam, 2007; Johansson et al , 2007; Pugliese et al , 2007; Sachs et al , 2007; Gill et al , 2009; Hanna et al , 2010). All these studies were perioperative giving rFVIIa either before the procedure or at a distinct bleeding trigger in the perioperative setting (Sachs et al , 2007; Gill et al , 2009).…”

Section: Summary Of Benefits Of Rfviiamentioning

confidence: 99%

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The evidence for the use of recombinant factor VIIa in massive bleeding: revision of the transfusion policy framework

Moltzan¹,

Anderson²,

Callum³

et al. 2012

Transfusion Medicine

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In 2006, the Canadian National Advisory Committee on Blood and Blood Products (NAC) developed a transfusion policy framework for the use of off-label recombinant factor VIIa (rFVIIa) in massive bleeding. Because the number of randomised controlled trials has doubled, the NAC undertook a review of the policy framework in 2011. On the basis of the review of 29 randomised controlled trials, there remains little evidence to support the routine use of rFVIIa in massive bleeding. Mortality benefits have not been demonstrated. Contrarily, an increase in arterial thromboembolic events has been observed with the use of off-label rFVIIa. Given the absence of evidence of benefit and with evidence of the risk of harm, the NAC recommends that recombinant VIIa no longer be used for the off-label indications of prevention and treatment of bleeding in patients without haemophilia.

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Recombinant Activated Factor VII in Spinal Surgery

Abstract: No safety concerns were indicated for the use of rFVIIa in patients at all doses tested; rFVIIa reduced adjusted blood loss and adjusted transfusions during spinal surgery.

Cited by 65 publications

References 32 publications

Prophylactic Activated Recombinant Factor VII in Liver Resection and Liver Transplantation: Systematic Review and Meta-Analysis

Prophylactic Activated Recombinant Factor VII in Liver Resection and Liver Transplantation: Systematic Review and Meta-Analysis

Predictive factors for perioperative blood transfusion in surgeries for correction of idiopathic, neuromuscular or congenital scoliosis

The evidence for the use of recombinant factor VIIa in massive bleeding: revision of the transfusion policy framework

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