ArticleAnnals of internal medicine2011
Off-label use of recombinant factor VIIa in U.S. hospitals: analysis of hospital records.
Article in Annals of internal medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
36 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia.The Cochrane database of systematic reviews · 2012Pooled it
- Systematic review: benefits and harms of in-hospital use of recombinant factor VIIa for off-label indications.Annals of internal medicine · 2011Pooled it
- Low concentrations of recombinant activated factor VII normalize coagulation patterns by reversing the changes in viscoelastic testing parameters induced by abelacimabResearch and practice in thrombosis and haemostasis · 2025Article
- Site-directed mutagenesis of tissue factor pathway inhibitor-binding exosite D60A on factor VII results in a new factor VII variant with lower coagulant activity.Research and practice in thrombosis and haemostasis · 2024Article
- Therapeutic doses of recombinant factor VIIa in hemophilia generates thrombin in platelet-dependent and -independent mechanisms.Journal of thrombosis and haemostasis : JTH · 2020Article
- Risk factors of diffuse alveolar hemorrhage after acute ischemic stroke treated with tissue-type plasminogen activator. The effectiveness of activated recombinant factor VII treatment.Surgical neurology international · 2020Article
- Hemostatic Agents in Critically Ill Patients.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2019Article
- Increased Accumulation and Retention of rhFVIIa (eptacog beta) in Knee Joints of Hemophilia A Mice Compared to Wild-Type Mice.Thrombosis and haemostasis · 2019Article
- Use of low dose of rFVIIa (recombinant Factor VII activated) to control late bleeding after percutaneous dilational tracheostomy.Clinical case reports · 2019Article
- Article
- Nebulised recombinant activated factor VII (rFVIIa) does not attenuate the haemorrhagic effects of blast lung injury.Journal of the Royal Army Medical Corps · 2019Article
- Recombinant activated factor VII (rFVIIa) in refractory haemorrhage for non-haemophiliacs: an eleven-year single-centre experience.BMC hematology · 2018Article
- Factors and Costs Associated With Delay in Treatment Initiation and Prolonged Length of Stay With Inpatient EPOCH Chemotherapy in Patients With Hematologic Malignancies.Cancer investigation · 2017Article
- Response to treatment and adverse events associated with use of recombinant activated factor VII in children: a retrospective cohort study.Therapeutic advances in drug safety · 2017Article
- Safety, Utilization, and Cost of Image-Guided Percutaneous Liver Biopsy Among Cancer Patients.Cancer investigation · 2016Article
- Recombinant Activated Factor VII Significantly Reduces Transfusion Requirements in Cardiothoracic Surgery.Drugs in R&D · 2015Article
- Trends in use and safety of image-guided transthoracic needle biopsies in patients with cancer.Journal of oncology practice · 2015Article
- Quality and Outcomes of Treatment of Hypercalcemia of Malignancy.Cancer investigation · 2015Article
- The endothelial protein C receptor enhances hemostasis of FVIIa administration in hemophilic mice in vivo.Blood · 2014Article
- Recombinant human factor VIIa for alveolar hemorrhage following allogeneic stem cell transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2014Article
Corrections and comments
- Commented on by
- Commented on by
- Commented on by
Authors and funding
3 authors.
Funding
Abstract
backgroundRecombinant factor VIIa (rFVIIa) is approved for treatment of bleeding in patients who have hemophilia with inhibitors but has been applied to a wide range of off-label indications.
objectiveTo estimate patterns of off-label rFVIIa use in U.S. hospitals.
designRetrospective database analysis.
settingData were extracted from the Premier Perspectives database (Premier, Charlotte, North Carolina), which contains discharge records from a sample of academic and nonacademic U.S. hospitals. PATIENTS: 12 644 hospitalizations for patients who received rFVIIa during a hospital stay. MEASUREMENTS: Hospital diagnoses and patient dispositions from 1 January 2000 to 31 December 2008. Statistical weights for each hospital were used to provide national estimates of rFVIIa use.
resultsFrom 2000 to 2008, off-label use of rFVIIa in hospitals increased more than 140-fold, such that in 2008, 97% (95% CI, 96% to 98%) of 18 311 in-hospital uses were off-label. In contrast, in-hospital use for hemophilia increased less than 4-fold and accounted for 2.7% (CI, 1.9% to 3.5%) of use in 2008. Adult and pediatric cardiovascular surgery (29% [CI, 21% to 33%]), body and brain trauma (29% [CI, 19% to 38%]), and intracranial hemorrhage (11% [CI, 7.7% to 14%]) were the most common indications for rFVIIa use. Across all indications, in-hospital mortality was 27% (CI, 19% to 34%) and 43% (CI, 26% to 59%) of patients were discharged to home. LIMITATION: Accuracy and completeness of the discharge diagnoses and patient medication records in the database sample cannot be verified.
conclusionOff-label use of rFVIIa in the hospital setting far exceeds use for approved indications. These patterns raise concern about the application of rFVIIa to conditions for which strong supporting evidence is lacking.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.