Retrospective study evaluating safety, clinical effect, and dosing of dalteparin for the treatment of venous thromboembolism in term neonates
Rattachement africain : us, gb. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
BACKGROUND: There is an increased risk of venous thromboembolism (VTE) among neonates due to their unique hemostatic system. However, there is lack of approved treatment options for VTE in neonatal population. Importantly, dalteparin, a low molecular weight heparin approved for pediatric VTE in children ≥1 month of age, has also been used for the treatment of neonatal VTE. Based on the request from the Food and Drug Administration, this retrospective study aimed to characterize the safety, clinical effects, and dosing of dalteparin for treatment of VTE among neonates. PROCEDURE: Data from electronic medical records for neonates (born ≥35 weeks of gestation) treated with dalteparin for VTE between January 2010 and December 2021 were collected. The data assessed included bleeding and deterioration in hematological biomarkers among other adverse events, changes in relevant factor antifactor Xa (anti-Xa) levels and VTE status, and dosing of dalteparin and corresponding anti-Xa assay levels. RESULTS: Sixteen neonates from five participating sites in the United Kingdom were included. There were no bleeding events or deaths. Only one serious adverse event of hypoglycemic brain injury (unrelated to dalteparin) was documented in a patient with a history of hyperinsulinism. Median (range) daily dose of dalteparin at initiation was 309 (297-314) IU/kg. Eight of 16 neonates achieved therapeutic anti-Xa level, including two patients who did so after the first dose. CONCLUSIONS: Dalteparin treatment in neonates raised no major safety concerns. Larger cohort studies may help provide further insights on clinical effects of dalteparin for neonatal VTE.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Retrospective study evaluating safety, clinical effect, and dosing of dalteparin for the treatment of venous thromboembolism in term neonates
- Date Crossref
- 25/07/2024
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Pfizer (United States) pays non établi dans la noticeEntreprise
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King's College London pays non établi dans la noticeUniversité ou école supérieure
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Guy's and St Thomas' NHS Foundation Trust pays non établi dans la noticeÉtablissement de santé
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University Hospitals of Leicester NHS Trust pays non établi dans la noticeÉtablissement de santé
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NHS Fife pays non établi dans la noticeÉtablissement de santé
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Victoria Hospital pays non établi dans la noticeÉtablissement de santé
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University of Leicester pays non établi dans la noticeUniversité ou école supérieure
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Pfizer Inc. Collegeville Pennsylvania USA Pfizer Inc. pays non établi dans la noticeUniversité ou école supérieure
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Oxford University Hospitals NHS Foundation Trust Leicester UK pays non établi dans la noticeUniversité ou école supérieure
Pfizer (United States), King's College London et Guy's and St Thomas' NHS Foundation Trust, avec 6 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.