Comparison of low- and high-dose recombinant activated factor VII for postcardiac surgical bleeding

Habib, Aly Makram

doi:10.4103/0972-5229.190365

Cited by 10 publications

(4 citation statements)

References 29 publications

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“…All of the included studies were randomized controlled trials, included cardiac surgery [15,18,22], intracerebral hemorrhage [14,19,21,23], postpartum haemorrhage [16], severe acute pancreatitis [17], trauma [20] and upper gastrointestinal haemorrhage [24]. Besides, there were no heterogeneity among studies on most outcomes and sensitivity analysis also suggested the results were not affected by individual research.…”

Section: Discussionmentioning

confidence: 99%

The efficiency and safety of recombinant factor VIIa for bleeding in patients without haemophilia: a meta-analysis of 12 randomized controlled trials

Zhang

Wang

et al. 2020

Preprint

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Background: Despite widely use of recombinant factor VIIa (rFVIIa) for bleeding in patients without haemophilia, its efficiency and safety remain unclear. Therefore, we carried out a meta-analysis on this topic. Methods: We searched Cochrane Library, Web of Science, PubMed and Embase, from January 2008 to July 2019 for randomized controlled trials on the topic. The results of this work are synthesized and reported in accordance with the PRISMA statement. Results: Twelve trials met our inclusion criteria. rFVIIa over 200ug/kg reduced red blood cell (RBC) transfusions within 24 h by 232.34ml (95% confidence interval [CI]; -410.31 to -54.37). rFVIIa did not significantly reduce 30-day mortality (relative risk [RR], 1.00; 95%CI, 0.82-1.21), total thromboembolic events (RR, 1.13; 95%CI, 0.94-1.36), myocardial infarction (RR, 1.37; 95%CI, 0.92-2.05), deep vein thrombosis (RR, 0.83; 95%CI, 0.52–1.33), ICU staying (RR, 0.40; 95%CI, -1.28 to 2.07) and number of patients transfused RBC (RR, 0.94; 95%CI, 0.83-1.08). However, rFVIIa may increase the incidence of arterial thrombotic events (RR, 1.38; 95%CI, 1.08–1.77). Conclusion: rFVIIa over 200ug/kg reduced RBC transfusions for bleeding in patients without haemophilia. However, it may increase the risk of arterial thrombotic events.

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Section: Discussionmentioning

confidence: 99%

The efficiency and safety of recombinant factor VIIa for bleeding in patients without haemophilia: a meta-analysis of 12 randomized controlled trials

Zhang

Wang

et al. 2020

Preprint

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“…The literature indicates no difference in efficacy endpoints between low doses (<40 mcg/kg) compared to medium doses (41-80 mcg) and high doses (81-100 mcg/kg) of rFVIIa. 9,[14][15][16][17][18][19][20][21][22] Even lower doses of rFVIIa (range 11.1-32 mcg/kg) have been reported as efficacious. 9,[14][15][16][17][18][19][20][21]23,24 Low doses of rFVIIa have not been associated with increased adverse events, while higher doses of rFVIIa have been shown to significantly increase the risk of arterial TE events.…”

Section: Introductionmentioning

confidence: 99%

Alternative Factor Prescribing after Low-Dose Recombinant Factor VIIa Protocol in Cardiac Surgery

Momenzadeh

Meyer

Leon

et al. 2022

Preprint

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BackgroundSafety concerns exist with the off-label use of recombinant factor VIIa (rFVIIa, Novoseven RT®) for refractory bleeding in cardiac surgery, including increased risk of thromboembolism. A rFVIIa protocol was implemented in December 2015 to standardize rFVIIa for cardiac surgery related hemorrhage.MethodsWe performed a retrospective, observational review of rFVIIa in adult cardiac surgery patients pre-protocol (January 2015 to November 2015) vs. post-protocol (December 2015 to March 2016). Study outcomes were rate of rFVIIa administration, rFVIIa dosing characteristics, length of stay, mortality, readmission rate, need for re-exploration, and rate of 4-factor Prothrombin Complex Concentrates (PCC; Kcentra®) administration.ResultsThere was a significant reduction in percentage of cardiac surgery cases receiving rFVIIa pre-vs. post-protocol (14.3 vs. 5.2%, p=0.015). Average total dose per patient decreased between groups (81.4 vs. 56.6 mcg/kg, p=0.059). In-hospital mortality, length of stay, need for re-exploration, readmission rates and 30-day mortality did not differ. Although 4-four-factor PCC significantly increased post-protocol (2.5% vs. 8%, p=0.02), overall use of factor products, rFVIIa or 4-factor PCC, did not change between study periods (16.8% vs. 13%, p=0.416). Mean cost of either rFVIIa or 4-factor PCC pre-protocol was significantly higher than that post-protocol ($8,778 vs. $4,421, p=0.0008).ConclusionsThe use of rFVIIa decreased after implementation of a rFVIIa protocol targeting 30 mcg/kg/dose without compromising morbidity or mortality outcomes. Four-factor PCC use significantly increased during the study, but the overall cost was reduced. Institutions wanting to implement a rFVIIa protocol should take careful measures to concurrently address off-label use of 4-factor PCC.

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“…Previous reports for cardiac surgical bleeding describe administration of very low-dose rFVIIa (vld-rFVIIa) consisting of median doses of 12-50 mg/kg [14][15][16][17][18]. These trials showed various benefits with potentially less risk of adverse outcomes.…”

Section: Introductionmentioning

confidence: 99%

Very low-dose recombinant Factor VIIa administration for cardiac surgical bleeding reduces red blood cell transfusions and renal risk: a matched cohort study

Cotter¹,

Sharma

Campton

et al. 2021

Blood Coagulation &Amp; Fibrinolysis

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Outcomes following administration of very-low-dose recombinant activated factor VIIa (vld-rFVIIa) for cardiac surgical bleeding remain debatable. We sought to determine the association of vld-rFVIIa and adverse surgical outcomes. Retrospective, cohort matching of patients undergoing cardiac surgery who received vld-rFVIIa (median 13.02 μg/kg) for perioperative bleeding were matched to cardiac surgical patients who had bleeding and received standard of care for bleeding without Factor VIIa administration. Of the 362 matched patients (182 in each group), patients who received rFVIIa required significantly less red blood cell transfusions [median 3 units (range 0--60, IQR = 4 units) versus 4 units (range 2-34, IQR = 4 units); P = 0.0004], decreased length of hospital stay (median 8 versus 9 days; P = 0.0158) and decreased renal risk (P < 0.0001). Incidence of renal failure, postoperative infection, postoperative thrombosis, prolonged ventilation, total ICU hours and 30-day mortality were not different between the two groups. Vld-rFVIIa for cardiac surgical bleeding was associated with decreased red blood cell transfusion, renal risk and length of hospital stay without increased thromboembolism or mortality when compared to patients who had cardiac surgical bleeding and received standard of care without Factor VIIa.

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Comparison of low- and high-dose recombinant activated factor VII for postcardiac surgical bleeding

Cited by 10 publications

References 29 publications

The efficiency and safety of recombinant factor VIIa for bleeding in patients without haemophilia: a meta-analysis of 12 randomized controlled trials

The efficiency and safety of recombinant factor VIIa for bleeding in patients without haemophilia: a meta-analysis of 12 randomized controlled trials

Alternative Factor Prescribing after Low-Dose Recombinant Factor VIIa Protocol in Cardiac Surgery

Very low-dose recombinant Factor VIIa administration for cardiac surgical bleeding reduces red blood cell transfusions and renal risk: a matched cohort study

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