Antithrombotic and hemostatic stewardship: evaluation of clinical outcomes and adverse events of recombinant factor VIIa (Novoseven
Academic Medical Centers
/ economics
Aged
Anticoagulants
/ adverse effects
Blood Loss, Surgical
/ prevention & control
Cardiac Surgical Procedures
/ adverse effects
Child
Child, Preschool
Drug Costs
Drug Dosage Calculations
Drug Utilization Review
Factor VIIa
/ administration & dosage
Female
Hemorrhage
/ chemically induced
Hemostatics
/ administration & dosage
Humans
Infant
Infant, Newborn
Male
Middle Aged
New York City
Off-Label Use
Practice Patterns, Physicians'
/ economics
Recombinant Proteins
/ administration & dosage
Retrospective Studies
Risk Factors
Thromboembolism
/ chemically induced
Treatment Outcome
cardiac surgery
hemorrhage
hemostasis
rFVIIa
thromboembolism
Journal
Therapeutic advances in cardiovascular disease
ISSN: 1753-9455
Titre abrégé: Ther Adv Cardiovasc Dis
Pays: England
ID NLM: 101316343
Informations de publication
Date de publication:
Historique:
entrez:
26
5
2020
pubmed:
26
5
2020
medline:
24
6
2020
Statut:
ppublish
Résumé
Recombinant factor VIIa (rFVIIa) (Novoseven®) is utilized for the reversal of anticoagulation-associated bleeding and refractory bleeding in cardiac surgery. In August 2015, rFVIIa was transferred from the blood bank to the pharmacy at New York University (NYU) Langone Health. Concordantly, an off-label dosing guideline was developed. The objective of this study was to describe utilization and cost of rFVIIa and assess compliance to our dosing guideline. We performed a retrospective, observational review of rFVIIa administrations post-implementation of an off-label dosing guideline. All patients who received rFVIIa between September 2015 and June 2017 were evaluated. For each rFVIIa administration, anticoagulation and laboratory values, indications for use, dosing, ordering and administration times, concomitant blood products, and adverse events were collected. Adverse events included venous thromboembolism, stroke, myocardial infarction, and death due to systemic embolism and mortality. The primary endpoint was the utilization of rFVIIa in accordance with the off-label dosing guideline. Secondary endpoints included hemostatic efficacy of rFVIIa, adverse events, blood products administered, and cost-effectiveness of rFVIIa transition to pharmacy. A total of 63 patients [pediatric ( Administration of rFVIIa for cardiac surgery appears to be effective for hemostasis. Transitioning rFVIIa from the blood bank to pharmacy and implementation of a dosing guideline appears to have reduced utilization. Patients receiving rFVIIa should be monitored for thromboembolic events. Elderly patients may be at higher risk for thromboembolic events.
Sections du résumé
BACKGROUND
BACKGROUND
Recombinant factor VIIa (rFVIIa) (Novoseven®) is utilized for the reversal of anticoagulation-associated bleeding and refractory bleeding in cardiac surgery. In August 2015, rFVIIa was transferred from the blood bank to the pharmacy at New York University (NYU) Langone Health. Concordantly, an off-label dosing guideline was developed. The objective of this study was to describe utilization and cost of rFVIIa and assess compliance to our dosing guideline.
METHODS
METHODS
We performed a retrospective, observational review of rFVIIa administrations post-implementation of an off-label dosing guideline. All patients who received rFVIIa between September 2015 and June 2017 were evaluated. For each rFVIIa administration, anticoagulation and laboratory values, indications for use, dosing, ordering and administration times, concomitant blood products, and adverse events were collected. Adverse events included venous thromboembolism, stroke, myocardial infarction, and death due to systemic embolism and mortality. The primary endpoint was the utilization of rFVIIa in accordance with the off-label dosing guideline. Secondary endpoints included hemostatic efficacy of rFVIIa, adverse events, blood products administered, and cost-effectiveness of rFVIIa transition to pharmacy.
RESULTS
RESULTS
A total of 63 patients [pediatric (
CONCLUSION
CONCLUSIONS
Administration of rFVIIa for cardiac surgery appears to be effective for hemostasis. Transitioning rFVIIa from the blood bank to pharmacy and implementation of a dosing guideline appears to have reduced utilization. Patients receiving rFVIIa should be monitored for thromboembolic events. Elderly patients may be at higher risk for thromboembolic events.
Identifiants
pubmed: 32449469
doi: 10.1177/1753944720924255
pmc: PMC7249557
doi:
Substances chimiques
Anticoagulants
0
Hemostatics
0
Recombinant Proteins
0
recombinant FVIIa
AC71R787OV
Factor VIIa
EC 3.4.21.21
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
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