Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and safety of a VWF/FVIII concentrate (wilate®) in inherited von Willebrand disease patients undergoing surgical procedures
Haemophilia, Volume 23, No. 2, Year 2017
Notification
URL copied to clipboard!
Description
Introduction: Surgical procedures in von Willebrand disease (VWD) patients may require prophylactic treatment with exogenous von Willebrand factor (VWF) and coagulation factor VIII (FVIII) to prevent excessive bleeding. Wilate® is a plasma-derived, double virus-inactivated, highly purified, freeze-dried VWF/FVIII concentrate, containing both factors in a physiological activity ratio of 1:1. Aim: To investigate the efficacy and safety of wilate® in maintaining haemostasis in VWD patients undergoing surgical procedures. Methods: This prospective, open-label multinational clinical study documents 28 individuals who underwent 30 surgical procedures managed with wilate®. Twenty-one patients had VWD Type 3, and 21 surgeries were major. Efficacy was assessed intra- and postoperatively by the surgeon and investigator, respectively, and adjudicated by an Independent Data Monitoring Committee, using an objective scale based on blood loss, transfusion requirements and postoperative bleeding and oozing. Treatment success (primary endpoint) was determined using a composite assessment algorithm and was formally assessed. Results: Surgical prophylaxis with wilate® was successful in 29 of 30 procedures. The overall rate of success was 96.7% (98.75% CI: 0.784, 1.000). All 21 surgeries in patients with VWD Type 3 were managed successfully. There was no accumulation of VWF or FVIII after multiple dosing, and no thromboembolic events or inhibitors to VWF or FVIII were observed. Conclusions: Wilate® demonstrated effective prevention and treatment of bleeding in inherited VWD patients undergoing surgery, with no clinically significant safety concerns. © 2016 The Authors. Haemophilia Published by John Wiley & Sons Ltd.
Authors & Co-Authors
Srivastava, Alok
India, Vellore
Christian Medical College, Vellore
Şerban, Margit A.
Romania, Timisoara
Emergency Hospital for Children Louis Turcanu
Kessler, Craig M.
United States, Washington, D.c.
Georgetown University Medical Center
Al-Kindi, Salam Salim Amur
Unknown Affiliation
Apte, Shashikant Janardan
Unknown Affiliation
Castaman, Giancarlo C.
Unknown Affiliation
Gill, Joan Cox
Unknown Affiliation
Hellmann, Andrzej
Unknown Affiliation
Kavaklı, Kaan R.
Unknown Affiliation
Kouides, Peter A.
Unknown Affiliation
Kuriakose, Philip A.
Unknown Affiliation
Mahlangu, Johnny Ndoni
Unknown Affiliation
Morfini, Massimo
Unknown Affiliation
Neufeld, Ellis J.
Unknown Affiliation
Peyvandi, Flora A.
Unknown Affiliation
Reding, Mark T.
Unknown Affiliation
Ross, Cecil Reuben
Unknown Affiliation
Rusen, Luminita
Unknown Affiliation
Shapiro, Amy D.
Unknown Affiliation
Windyga, Jerzy
Unknown Affiliation
Zul̈fikar, Bul̈ent
Unknown Affiliation
Statistics
Citations: 25
Authors: 21
Affiliations: 3
Identifiers
Doi:
10.1111/hae.13106
ISSN:
13518216
Research Areas
Health System And Policy
Study Design
Cohort Study