Phase 3 study of recombinant von Willebrand factor in patients with severe von Willebrand disease who are undergoing elective surgery.
Adult
Aged
Blood Loss, Surgical
/ prevention & control
Coagulants
/ administration & dosage
Elective Surgical Procedures
/ adverse effects
Female
Hemostasis
/ drug effects
Humans
Male
Middle Aged
Prospective Studies
Recombinant Proteins
/ administration & dosage
Severity of Illness Index
Time Factors
Treatment Outcome
Young Adult
von Willebrand Diseases
/ blood
von Willebrand Factor
/ administration & dosage
clinical trial
general surgery
pharmacodynamics
von Willebrand disease
von Willebrand factor
Journal
Journal of thrombosis and haemostasis : JTH
ISSN: 1538-7836
Titre abrégé: J Thromb Haemost
Pays: England
ID NLM: 101170508
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
received:
24
04
2018
pubmed:
27
10
2018
medline:
14
4
2020
entrez:
27
10
2018
Statut:
ppublish
Résumé
Essentials Recombinant von Willebrand factor (rVWF) is effective in von Willebrand disease (VWD). A phase 3 study of rVWF, with/without recombinant factor VIII (rFVIII) before surgery in VWD. Overall rVWF's efficacy was rated excellent/good; rVWF was administered alone in most patients. rVWF was well-tolerated and hemostasis was achieved in patients with severe VWD undergoing surgery. SUMMARY: Background Recombinant von Willebrand factor (rVWF) has demonstrated efficacy for on-demand treatment of bleeding in severe von Willebrand disease (VWD), warranting evaluation in the surgical setting. Objectives This study (NCT02283268) evaluated the hemostatic efficacy/safety profile of rVWF, with/without recombinant factor VIII (rFVIII), in patients with severe VWD undergoing surgery. Patients/Methods Patients received rVWF 40-60 IU kg
Identifiants
pubmed: 30362288
doi: 10.1111/jth.14313
pmc: PMC7379610
pii: S1538-7836(22)03020-3
doi:
Substances chimiques
Coagulants
0
Recombinant Proteins
0
von Willebrand Factor
0
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
52-62Subventions
Organisme : Baxalta
Pays : International
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2018 Shire International GmbH Journal of Thrombosis and Haemostasis © 2018 International Society on Thrombosis and Haemostasis.
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