title: Heparin-bonded central venous catheters do not reduce thrombosis in infants with congenital heart disease: a blinded randomized, controlled trial.
abstract: BACKGROUND
  Infants with congenital heart disease who require central venous lines are at increased risk of thrombosis. Heparin-bonded catheters provide protection from thrombotic events in some children. However, heparin-bonded catheters may not be as effective in infants </=1 year old because of other potential risk factors (smaller vessel size, longer duration of catheter use). No studies have assessed the benefit of heparin-bonded catheters in such specific high-risk populations. The objective of this study was to assess the efficacy of heparin-bonded catheters for preventing thrombosis in infants aged </=1 year with congenital heart disease.
  
  
  METHODS
  This study was designed as a randomized, controlled, blinded single-center trial. Infants </=1 year old with congenital heart disease requiring a central venous line for clinical care were randomly assigned to receive either a heparin-bonded catheter or a standard non-heparin-bonded catheter. Catheters were visually indistinguishable. The primary outcome was incidences of both silent and clinically noticeable thrombosis confirmed by ultrasound. Ultrasounds were reviewed by a blinded central adjudication committee. Interim analysis was performed after enrollment of 97 patients.
  
  
  RESULTS
  Eighty-seven patients were evaluable (41 of the patients were female). Thrombotic events occurred in 17 (42.5%) of 40 patients in the non-heparin-bonded catheter group and in 21 (44.7%) of 47 patients in the heparin-bonded catheters group. The study was stopped when the interim analysis showed convincing evidence for no difference between groups over the alternative hypothesis of 50% risk reduction.
  
  
  CONCLUSIONS
  Infants with congenital heart disease are at significant risk of both silent and clinically identified thrombosis. There seems to be no advantage in using heparin-bonded catheters in infants </=1 year of age.
authors.affiliation: Stollery Children's Hospital, Department of Pediatrics, University of Alberta, Dentistry Pharmacy Centre, 11304-89 Avenue, Edmonton, Alberta, Canada.
authors.forename: Natalie
authors.initials: N
authors.lastname: Anton
authors.forename: Peter N
authors.initials: PN
authors.lastname: Cox
authors.forename: M Patricia
authors.initials: MP
authors.lastname: Massicotte
authors.forename: Peter
authors.initials: P
authors.lastname: Chait
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Yasui
authors.forename: P Maria
authors.initials: PM
authors.lastname: Dinyari
authors.forename: Velma
authors.initials: V
authors.lastname: Marzinotto
authors.forename: Lesley G
authors.initials: LG
authors.lastname: Mitchell
mesh_terms: D002405:Catheterization, Central Venous / Q000295:instrumentation*; D020099:Coated Materials, Biocompatible; D003430:Cross-Sectional Studies; D004311:Double-Blind Method; D005260:Female; D006330:Heart Defects, Congenital / Q000097:blood*; D006493:Heparin; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D013927:Thrombosis / Q000097:blood / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000517:prevention & control*; D014463:Ultrasonography
chemical_list: D020099:Coated Materials, Biocompatible; D006493:Heparin