Objective: To determine whether a continuous infusion of heparin reduces the rate of catheter-related thrombosis in neonates and infants post cardiac surgery. Central venous and intracardiac catheters are used routinely in postoperative pediatric cardiac patients. Catheter-related thrombosis occurs in 8% to 45% of pediatric patients with central venous catheters.
Design: Single-center, randomized, placebo-controlled, double-blinded trial.
Setting: Cardiovascular intensive care unit, university-affiliated children's hospital.
Patients: Children <1 yr of age recovering from cardiac surgery.
Interventions: Patients were randomized to receive either continuous heparin at 10 units/kg/hr or placebo. The primary end point was catheter-related thrombosis as assessed by serial ultrasonography.
Results: Study enrollment was discontinued early based on results from an interim futility analysis. Ninety subjects were enrolled and received the study drug (heparin, 53; placebo, 37). The catheter-related thrombosis rate in the heparin group, compared with the placebo group, was 15% vs. 16% (p = .89). Subjects in the heparin group had a higher mean partial thromboplastin time (52 secs vs. 42 secs, p = .001), and this difference was greater for those aged <30 days (64 secs vs. 43 secs, p = .008). Catheters in place ≥7 days had both a greater risk of thrombus formation (odds ratio, 4.3; p = .02) and catheter malfunction (odds ratio, 11.2; p = .008). We observed no significant differences in other outcome measures or in the frequency of adverse events.
Conclusions: A continuous infusion of heparin at 10 units/kg/hr was safe but did not reduce catheter-related thrombus formation. Heparin at this dose caused an increase in partial thromboplastin time values, which, unexpectedly, was more pronounced in neonates.
From the Departments of Pediatrics (ARS, DMA, NHS, EM, SJR) and Radiology (ER), Stanford University School of Medicine, Palo Alto, CA; and the Department of Pediatrics (ARS), Santa Clara Valley Medical Center, San Jose, CA.
Results from the first interim analysis of this study were presented, in part, as an abstract (#9646) at the 2007 American Heart Association Annual Scientific Sessions, Orlando, Florida, November 4–7, 2007.
This study was funded, in part, by a grant from the Pediatric Health Research Fund at the Stanford University School of Medicine.
Clinical Trials Registration: http://www.clinicaltrials.gov. Trial number NCT00779558.
The authors have not disclosed any potential conflicts of interest.
For information regarding this article, E-mail: Alan.Schroeder@hhs.sccgov.org