Heparin-bonded central venous catheters do not reduce thrombosis in infants with congenital heart disease: a blinded randomized, controlled trial.
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.
Anton
Natalie
N
Stollery Children's Hospital, Department of Pediatrics, University of Alberta, Dentistry Pharmacy Centre, 11304-89 Avenue, Edmonton, Alberta, Canada.
Cox
Peter N
PN
Massicotte
M Patricia
MP
Chait
Peter
P
Yasui
Yutaka
Y
Dinyari
P Maria
PM
Marzinotto
Velma
V
Mitchell
Lesley G
LG
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
D020099:Coated Materials, Biocompatible; D006493:Heparin