Effect of recombinant Factor VIIa on outcome of acute variceal bleeding: An individual patient based meta-analysis of two controlled trials

Bendtsen, Flemming; D’Amico, Gennaro; Rusch, Ea; Franchis, Roberto de; Andersen, Per Kragh; Lebrec, Didier; Thabut, Dominique; Bosch, Jackie

doi:10.1016/j.jhep.2014.03.035

Cited by 42 publications

(23 citation statements)

References 19 publications

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“…In cirrhotics, routine coagulation tests cannot define the coagulation status and the bleeding risk. Several observational and randomized placebo-controlled studies have shown that prothrombin time (PT) is a poor predictor of peri-or post-operative bleeding in patients with cirrhosis [60,61,63]. In most invasive procedures, a 50 × 10 9 /l platelets cut-off is utilized for defining the need for blood product to correct preoperative laboratory values.…”

Section: Which Types Of Device Are Available For Tips?mentioning

confidence: 99%

Consensus conference on TIPS management: Techniques, indications, contraindications

Fagiuoli

Bruno

Venon

et al. 2017

Digestive and Liver Disease

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117

108

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a b s t r a c tThe trans jugular intrahepatic Porto systemic shunt (TIPS) is no longer viewed as a salvage therapy or a bridge to liver transplantation and is currently indicated for a number of conditions related to portal hypertension with positive results in survival. Moreover, the availability of self-expandable polytetrafluoroethylene (PTFE)-covered endoprostheses has dramatically improved the long-term patency of TIPS. However, since the last updated International guidelines have been published (year 2009) new evidence have come, which have open the field to new indications and solved areas of uncertainty. On this basis, the Italian Association of the Study of the Liver (AISF), the Italian College of Interventional Radiology-Italian Society of Medical Radiology (ICIR-SIRM), and the Italian Society of Anesthesia, Analgesia and Intensive Care (SIAARTI) promoted a Consensus Conference on TIPS. Under the auspices of the three scientific societies, the consensus process started with the review of the literature by a scientific board of experts and ended with a formal consensus meeting in Bergamo on June 4th and 5th, 2015. The final statements presented here were graded according to quality of evidence and strength of recommendations and were approved by an independent jury. By highlighting strengths and weaknesses of current indications to TIPS, the recommendations of AISF-ICIR-SIRM-SIAARTI may represent the starting point for further studies.

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Section: Which Types Of Device Are Available For Tips?mentioning

confidence: 99%

Consensus conference on TIPS management: Techniques, indications, contraindications

Fagiuoli

Bruno

Venon

et al. 2017

Digestive and Liver Disease

Self Cite

117

108

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“…40 A metaanalysis found that patients who received rFVIIa had a significantly lower re-bleeding rate during the first 5 days but there was no reduction in re-bleeding rate or mortality at 6 weeks. 41 A Cochrane systematic analysis also found that rFVIIa did not reduce mortality in patients with liver disease and upper GI bleeding and concluded there is insufficient evidence to support the use of rFVIIa in this setting. 42 Recombinant FVIIa is not approved for use in liver disease and off-label use is associated with an increased risk of arterial thromboembolism.…”

Section: Recombinant Factor Viiamentioning

confidence: 99%

“…42 Recombinant FVIIa is not approved for use in liver disease and off-label use is associated with an increased risk of arterial thromboembolism. 41 Recombinant FVIIa is rarely used as a salvage therapy and bridge to more definitive treatment in select cases of uncontrolled bleeding requiring urgent control. This decision requires careful consideration of potential thrombotic risks, as well as likely benefit.…”

Section: Recombinant Factor Viiamentioning

confidence: 99%

Coagulopathy in liver disease: a balancing act

Kujovich

2015

Hematology

109

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Liver disease results in complex alterations of all 3 phases of hemostasis. It is now recognized that hemostasis is rebalanced in chronic liver disease. The fall in clotting factor levels is accompanied by a parallel fall in anticoagulant proteins. High von Willebrand factor levels counteract defects in primary hemostasis. Conventional coagulation tests do not fully reflect the derangement in hemostasis and do not accurately predict the risk of bleeding. Global coagulation assays (thrombin generation, thromboelastography) reflect the interaction between procoagulant factors, anticoagulant factors, platelets, and the fibrinolytic system and show promise for assessing bleeding risk and guiding therapy. These assays are not yet commercially approved or validated. Prevention of bleeding should not be aimed at correcting conventional coagulation tests. Thrombopoietin receptor agonists were shown to increase the platelet count in cirrhotic patients undergoing invasive procedures

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“…16 Bendtsen et al, conducted a meta-analysis (n=497) of acute variceal bleeding in patients with end stage liver disease receiving rFVIIa or placebo. 17 While factor administration did decrease the recurrence of bleeding within five days of administration it did not affect the five day or 40-day survival of patients. Similarly, our study did not demonstrate a long term benefit of factor administration in patients with liver failure with active hemorrhage leading us to conclude previously evaluated surrogate markers are inappropriate given the risk benefit ratio of factor products.…”

Section: Discussionmentioning

confidence: 90%

Clinical Outcomes of a Pharmacy-Led Blood Factor Stewardship Program

Trueg

Lowe²,

Kiel³

2017

American Journal of Therapeutics

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To report the results of a pharmacist-directed blood factor stewardship program targeting off-label utilization designed to limit use to established organizational guidelines in high-risk populations. Prospective evaluation of recombinant factor VIIa and prothrombin complex concentrate orders beginning June 2013 through May 2014 and a matched retrospective cohort from June 2012 to May 2013. Matched cohorts were evaluated for 28-day mortality, change in international normalized ratio (INR), adverse events, concurrent blood product use, and cost savings. Forty-two orders for blood factor were ordered between June 2013 and May 2014, 70 orders in the year before (N = 112). Twenty eight–day mortality was not different between the cohorts: 53.9% versus 50% (P = 0.77). Blood factor use with underlying liver failure and active bleeding was strongly associated with 28-day mortality: odds ratio (95% confidence interval), 2.9 (1.5–7.14) and 2.91 (0.01–2.91), respectively. Blood products dispensed increased over the year with plasma products the most significant (1 vs. 4 P = 0.004). All other clinical outcomes were nonsignificant. An annual cost savings of $375,539 was achieved, primarily through a significant reduction in recombinant factor VIIa and avoidance in high-risk patients. Use of off-label blood factors can be controlled through a pharmacist-led stewardship program. Twenty eight–day mortality was not different between the 2 cohorts; however, identification of risk factors for death associated with blood factor use allows for restriction in high-risk populations, creates a discussion of futile care, and yields cost savings.

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Effect of recombinant Factor VIIa on outcome of acute variceal bleeding: An individual patient based meta-analysis of two controlled trials

Cited by 42 publications

References 19 publications

Consensus conference on TIPS management: Techniques, indications, contraindications

Consensus conference on TIPS management: Techniques, indications, contraindications

Coagulopathy in liver disease: a balancing act

Clinical Outcomes of a Pharmacy-Led Blood Factor Stewardship Program

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