ArticleThe Journal of pediatrics2011
Off-label recombinant factor VIIa use and thrombosis in children: a multi-center cohort study.
Article in The Journal of pediatrics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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
15 citing papers in PubMed, 68 citations in OpenAlex.
- Probabilistic Graphical Models for Evaluating the Utility of Data-Driven ICD Code Categories in Pediatric Sepsis.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2024Article
- Prothrombin Complex Concentrate Utilization in Children's Hospitals.Journal of pediatric intensive care · 2023Article
- The role of the calibrated automated thrombogram in neonates: describing mechanisms of neonatal haemostasis and evaluating haemostatic drugs.European journal of pediatrics · 2022Review
- Treatment of Diffuse Alveolar Hemorrhage: Controlling Inflammation and Obtaining Rapid and Effective Hemostasis.International journal of molecular sciences · 2021Review
- A concept analysis of children with complex health conditions: implications for research and practice.BMC pediatrics · 2020Article
- Oncologic Emergencies-The Old, the New, and the Deadly.Journal of intensive care medicine · 2020Review
- Recombinant activated factor seven in pediatric cardiac surgery-does thrombotic risk outweigh hemostatic benefit?Translational pediatrics · 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
- Neonatal thrombocytopenia: Thrombin generation in presence of reduced platelet counts and effects of rFVIIa in cord blood.Scientific reports · 2019Observational
- 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
- Diffuse alveolar hemorrhage and recombinant factor VIIa treatment in pediatric patients.Korean journal of pediatrics · 2016Review
- The endothelial protein C receptor enhances hemostasis of FVIIa administration in hemophilic mice in vivo.Blood · 2014Article
- Pediatric complex chronic conditions classification system version 2: updated for ICD-10 and complex medical technology dependence and transplantation.BMC pediatrics · 2014Article
- eComment. Recombinant activated factor VII in pediatric cardiac surgery: possibilities and limitations.Interactive cardiovascular and thoracic surgery · 2012Article
- Congenital FVII deficiency and thrombotic events after replacement therapy.Journal of thrombosis and thrombolysis · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
Abstract
objectiveTo describe the off-label use of recombinant factor VIIa (rFVIIa) in tertiary care pediatric hospitals across the United States and to assess thrombotic events. STUDY
designA retrospective multi-center cohort study using the Pediatric Health Information System administrative database. Children 18 years of age or younger who received rFVIIa between 2000 and 2007 were included. A label admission was defined as an admission with an International Classification of Diseases diagnostic code for hemophilia or factor VII deficiency; admissions without these codes were classified as off-label.
resultsThere were 4942 rFVIIa admissions, representing 3764 individual subjects; 74% (3655) of the admissions were off-label. There was a 10-fold increase in the annual rate of off-label admissions from 2000 to 2007 (from 2 to 20.8 per 10 000 hospital admissions, P < .001). The mortality rate in the off-label group was 34% (1258/3655). Thrombotic events occurred in 10.9% (399/3655) of the off-label admissions.
conclusionsThe off-label use of rFVIIa in hospitalized children is increasing rapidly despite the absence of adequate clinical trials demonstrating safety and efficacy. Thrombotic events are common and mortality is high among patients receiving off-label rFVIIa. Further studies are warranted to determine whether these adverse events are attributable to rFVIIa.
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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.