Background: Recombinant human coagulation factor VIIa (rVIIa) is a procoagulant indicated for treatment of bleeding in patients with hemophilia. A large proportion of rVIIa utilization is for off-label administration in nonhemophiliac patients with acute hemorrhage. Concerns of potentially inappropriate use, safety, and cost of rVIIa led to efforts to standardize use of this agent.
Objective: To comparatively describe the utilization of rVIIa upon implementation of an evidence-based guideline at a university hospital.
Methods: With advisory direction from a multidisciplinary task force, an evidence-based guideline for use of rVIIa was developed, approved, and fully implemented. Assessment of appropriateness of use and retrospective review were required for all cases. Effects of these actions were evaluated by auditing and comparing rVIIa use in patients treated in two 6-month observation periods before and after guideline implementation. Outcomes assessed were proportions of patients deemed appropriate to receive rVIIa, compliance with dosing recommendations, and acquisition costs.
Results: Twenty-two and 29 patients were treated in the periods before and after guideline implementation, respectively. Patient characteristics were similar, except more cardiothoracic surgeries were performed in patients treated before implementation of the guideline. Indications for rVIIa use were judged appropriate in 21 (95.5%) before-cases and in all (100%) after-cases. The dose was compliant in 1 (4.6%) before-case and 27 (93.1%) after-cases (p < 0.001). Mean dosages of rVIIa administered were 81.8 microg/kg and 45.3 microg/kg in before- and after-cases, respectively (p < 0.001). During the respective periods of observation, amounts of rVIIa purchased monthly averaged 42.6 mg and 21.8 mg, a 49% difference. Semiannual expenditures for rVIIa decreased approximately $110,000 following guideline implementation. Patient outcomes were similar.
Conclusions: A guideline based on currently available evidence can serve to sustain the clinical appropriateness of rVIIa therapy and substantially decrease costs.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1345/aph.1L047 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Background: Glanzmann thrombasthenia (GT) is a rare disease with an autosomal recessive inheritance pattern. This disorder is not so uncommonly encountered in routine clinical practice and laboratory settings in Pakistan let alone in the rest of the world. To describe the bleeding phenotype of GT and treatment outcomes in over one hundred patients in north Pakistan.
View Article and Find Full Text PDFAcquired Isolated Factor VII Deficiency in Plasma Cell Dyscrasias: A Brief Presentation of Two Plasma-Cell-Leukemia-Related Cases and Review of Literature.
J Clin Med
September 2023
Hematology Unit, Azienda ULSS2 Marca Trevigiana, 31100 Treviso, Italy.
Acquired isolated factor VII (FVII) deficiency is a rare but important discovery in patients with plasma cell disorders with significant therapeutic and prognostic implications. The present analysis and review of cases reported in the literature is intended to highlight disease-related characteristics associated with this rare clotting defect, clinical manifestations and outcome, and potential underlying mechanisms, and to provide guidance on how to manage these patients in terms of prophylactic and therapeutic measures. The discovery of acquired FVII deficiency in a patient with multiple myeloma (MM) or monoclonal gammopathy of uncertain significance (MGUS) should prompt an evaluation for AL amyloidosis, particularly for amyloid hepatosplenic involvement, whenever not previously documented.
View Article and Find Full Text PDFStem Cell Transplantation in Glanzmann's Thrombasthenia: A Report of Two Adult Patients.
J Coll Physicians Surg Pak
December 2022
Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan.
Glanzmann's thrombasthenia (GT) is an autosomal recessive bleeding disorder characterised by mucocutaneous bleeding. At molecular level, defect in platelet receptor glycoprotein (GP) IIb/IIIa leads to defective platelet aggregation. Anti-fibrinolytic agents, platelet transfusions, and factor rVIIa are used for prophylaxis before invasive procedures and treatment of bleeding events.
View Article and Find Full Text PDFEptacog Beta for Bleeding Treatment and Prevention in Congenital Hemophilia A and B With Inhibitors: A Review of Clinical Data and Implications for Clinical Practice.
Ann Pharmacother
July 2022
The Johns Hopkins Hospital, Baltimore, MD, USA.
Objective: To review the pharmacology, dosing and administration, safety, clinical efficacy, and role of eptacog beta in the treatment of congenital hemophilia with inhibitors.
Data Sources: A literature search of PubMed (1966 to August 2021) was conducted using the keywords , , and .
Study Selection And Data Extraction: All relevant published articles and prescribing information on eptacog beta for the treatment of congenital hemophilia with inhibitors were reviewed.
Recombinant Factor VIIa in Pediatric Cardiac Surgery.
J Cardiothorac Vasc Anesth
March 2022
Department of Anesthesia and Pain Management, The Royal Children's Hospital, Parkville, Australia. Electronic address:
Objectives: Recombinant activated factor VIIa (rVIIa) is used off-label for refractory bleeding after cardiac surgery. This study reviewed the indications, usage rates, and complications of rVIIa.
Design: A retrospective case-control observational study.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!