title: Results of the HepZero study comparing heparin-grafted membrane and standard care show that heparin-grafted dialyzer is safe and easy to use for heparin-free dialysis.
abstract: Heparin is used to prevent clotting during hemodialysis, but heparin-free hemodialysis is sometimes needed to decrease the risk of bleeding. The HepZero study is a randomized, multicenter international controlled open-label trial comparing no-heparin hemodialysis strategies designed to assess non-inferiority of a heparin grafted dialyzer (NCT01318486). A total of 251 maintenance hemodialysis patients at increased risk of hemorrhage were randomly allocated for up to three heparin-free hemodialysis sessions using a heparin-grafted dialyzer or the center standard-of-care consisting of regular saline flushes or pre-dilution. The first heparin-free hemodialysis session was considered successful when there was neither complete occlusion of air traps or dialyzer, nor additional saline flushes, changes of dialyzer or bloodlines, or premature termination. The current standard-of-care resulted in high failure rates (50%). The success rate in the heparin-grafted membrane arm was significantly higher than in the control group (68.5% versus 50.4%), which was consistent for both standard-of-care modalities. The absolute difference between the heparin-grafted membrane and the controls was 18.2%, with a lower bound of the 90% confidence interval equal to plus 7.9%. The hypothesis of the non-inferiority at the minus 15% level was accepted, although superiority at the plus 15% level was not reached. Thus, use of a heparin-grafted membrane is a safe, helpful, and easy-to-use method for heparin-free hemodialysis in patients at increased risk of hemorrhage.
authors.affiliation: Nephrology Department, Lyon-Sud Hospital Centre, Lyon University, Inserm U1060 CarMeN & Association pour l'Utilisation du Rein Artificiel à Lyon, Lyon, France.
authors.forename: Maurice
authors.initials: M
authors.lastname: Laville
authors.affiliation: Department of Nephrology, Dr Georges-L-Dumont University Hospital Centre, Moncton, New Brunswick, Canada.
authors.forename: Marc
authors.initials: M
authors.lastname: Dorval
authors.affiliation: Nephrology Department, University Hospital Vall d'Hebron, Autonomous University of Barcelona, Barcelona, Spain.
authors.forename: Joan
authors.initials: J
authors.lastname: Fort Ros
authors.affiliation: INSERM CIC 9501 & U1116, Nancy University Hospital, Lorraine University, Nancy, & Association Lorraine Pour le Traitement de l'Insuffisance Rénale, Vandoeuvre-lès-Nancy, France.
authors.forename: Renaud
authors.initials: R
authors.lastname: Fay
authors.affiliation: Nephrology Department, Nancy University Hospital, Lorraine University, Nancy, France.
authors.forename: Joëlle
authors.initials: J
authors.lastname: Cridlig
authors.affiliation: Nephrology Department, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Joëlle L
authors.initials: JL
authors.lastname: Nortier
authors.affiliation: Nephrology Department, Hôpital Edouard Herriot, Hospices Civils de Lyon, Université de Lyon, Lyon, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Juillard
authors.affiliation: Department of Nephrology, Transplantology and Internal Medicine, Medical University of Gdańsk, Gdańsk, Poland.
authors.forename: Alicja
authors.initials: A
authors.lastname: Dębska-Ślizień
authors.affiliation: Nephrology Department, Germans Trias i Pujol Hospital, Badalona, Barcelona, Spain.
authors.forename: Loreto
authors.initials: L
authors.lastname: Fernández Lorente
authors.affiliation: Nephrology, Dialysis and Transplantation Department, Hôpital Nord, CHU de Saint-Etienne, Saint-Etienne, France.
authors.forename: Damien
authors.initials: D
authors.lastname: Thibaudin
authors.affiliation: Department of Internal Medicine, Division of Nephrology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: Casper
authors.initials: C
authors.lastname: Franssen
authors.affiliation: Nephrology Department, Royal Liverpool Broadgreen University Hospital, Liverpool, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Schulz
authors.affiliation: Gambro-Hospal, Meyzieu, France.
authors.forename: Frédérique
authors.initials: F
authors.lastname: Moureau
authors.affiliation: Gambro-Hospal, Meyzieu, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Loughraieb
authors.affiliation: INSERM CIC 9501 & U1116, Nancy University Hospital, Lorraine University, Nancy, & Association Lorraine Pour le Traitement de l'Insuffisance Rénale, Vandoeuvre-lès-Nancy, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Rossignol
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D004868:Equipment Failure; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008567:Membranes, Artificial; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis / Q000379:methods*; D051437:Renal Insufficiency / Q000628:therapy; D012965:Sodium Chloride / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D020099:Coated Materials, Biocompatible; D008567:Membranes, Artificial; D012965:Sodium Chloride; D006493:Heparin