title: Vitamin E-Coated and Heparin-Coated Dialyzer Membranes for Heparin-Free Hemodialysis: A Multicenter, Randomized, Crossover Trial.
abstract: BACKGROUND
  Hemodialysis requires effective anticoagulation to avoid blood circuit clotting. In patients at high risk for bleeding, several alternative methods have been developed.
  
  
  METHODS
  Multicenter, prospective, randomized, crossover study evaluating the noninferiority of vitamin E-coated compared with heparin-coated dialyzers in a 4-hour heparin-free hemodialysis strategy.
  
  
  METHODS
  32 adult long-term hemodialysis patients from 2 French hemodialysis units with well-functioning fistulas or double-lumen catheters.
  
  
  METHODS
  Patients were randomly allocated to a first period using either vitamin E- or heparin-coated dialyzers. After a washout period of 2 hemodialysis sessions, each patient was switched to the alternative dialyzer for a second period. Each study period started with 2 hemodialysis sessions with reduced heparin dose (50% and 25% of usual heparin dose, respectively, for sessions 1 and 2) followed by 2 heparin-free sessions.
  
  
  RESULTS
  The primary end point was the percentage of successful study periods, defined as no circuit-clotting event leading to premature interruption of any of the 4 dialysis sessions. Secondary end points included total number and cumulative duration of hemodialysis sessions without clotting, number of saline solution flushes, dialysis circuit bubble trap status and dialyzer membrane status by visual inspection, and dialysis adequacy.
  
  
  RESULTS
  The percentage of success with vitamin E-coated dialyzers (25/32 study periods [78%]) was not inferior to that with heparin-coated dialyzers (26/32 study periods [81%]). Visual inspection showed equal numbers of clean dialysis circuit bubble traps (vitamin E-coated, 34/121; heparin-coated, 32/120), whereas clean fiber bundles were more frequently noted with the vitamin E-coated compared with heparin-coated dialyzers (25/121 vs 2/120; P=0.002).
  
  
  CONCLUSIONS
  Results may not extrapolate to critically ill patients. Differences in dialyzer transparency may account for visual inspection scores.
  
  
  CONCLUSIONS
  The success rate of 4-hour heparin-free hemodialysis sessions is lower than that previously claimed in uncontrolled studies. Vitamin E-coated and heparin-coated dialyzers exposed patients to similar and unacceptable high failure rates. Further studies are required to improve heparin-free hemodialysis.
authors.affiliation: Nephrology Department, Pasteur University Hospital of Nice, Nice, France. Electronic address: islam.ms@chu-nice.fr.
authors.forename: Mohamed Shariful
authors.initials: MS
authors.lastname: Islam
authors.affiliation: Nephrology Department, General Hospital of Avignon, Avignon, France.
authors.forename: Zarih Alcheikh
authors.initials: ZA
authors.lastname: Hassan
authors.affiliation: Nephrology Department, Pasteur University Hospital of Nice, Nice, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Chalmin
authors.affiliation: Nephrology Department, Pasteur University Hospital of Nice, Nice, France.
authors.forename: Sandor
authors.initials: S
authors.lastname: Vido
authors.affiliation: Nephrology Department, Pasteur University Hospital of Nice, Nice, France.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Berrada
authors.affiliation: Nephrology Department, General Hospital of Avignon, Avignon, France.
authors.forename: David
authors.initials: D
authors.lastname: Verhelst
authors.affiliation: Nephrology Department, General Hospital of Avignon, Avignon, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Donnadieu
authors.affiliation: Nephrology Department, Pasteur University Hospital of Nice, Nice, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Moranne
authors.affiliation: Nephrology Department, Pasteur University Hospital of Nice, Nice, France; Nice Sophia-Antipolis University, Nice, France.
authors.forename: Vincent L M
authors.initials: VL
authors.lastname: Esnault
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage*; D000975:Antioxidants / Q000008:administration & dosage*; D018592:Cross-Over Studies; D005260:Female; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008567:Membranes, Artificial; D011446:Prospective Studies; D006435:Renal Dialysis / Q000379:methods; D014810:Vitamin E / Q000008:administration & dosage*
chemical_list: D000925:Anticoagulants; D000975:Antioxidants; D008567:Membranes, Artificial; D014810:Vitamin E; D006493:Heparin
keywords: Heparin-free hemodialysis; anticoagulation; blood circuit clotting; end-stage renal disease (ESRD); fibrin ring; heparin-coated dialyzer; non-inferiority trial; randomized controlled trial; saline flushes; vitamin E-coated dialyzer