NCT00779558

Heparin and the Reduction of Thrombosis (HART) Trial

Heparin and Catheter-related Thrombosis in Neonates and Infants Following Cardiac Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 1 Day – 1 Year
• Healthy volunteers: Not accepted

Summary

Heparin is frequently used in central venous catheters (CVCs) in post-operative cardiac patients. It remains unclear if a heparin infusion, compared to a normal saline infusion, prevents thrombosis of CVCs after surgery. This study will answer the question: does a low-dose heparin infusion (10 units/kg/h) prevent thrombosis, compared to a normal saline infusion, in patients less than one year of age after cardiac surgery?

Detailed description

Patients are contacted pre-operatively and their parents consented. The following criteria apply: Inclusion criteria: All infants \< 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital Exclusion Criteria: Known coagulopathy History of clinically significant bleeding (GI, cranial, pulmonary) Need for therapeutic heparinization ECMO Randomization and blinding are performed in the Pharmacy. The intervention is initiated at the intensive care unit physician's discretion, generally within the 1st 24 hours post-operatively. The study is terminated when all catheters have been discontinued or at POD #14, whichever occurs first. Thrombosis is demonstrated by echocardiogram or ultrasound performed at 1 - 3 days, 5 - 7 days, and 10 - 14 days after initiation of the study drug. The following are calculations for statistical analysis: Sample size determination - Using 2 - sided alpha = 0.05 and Beta = 0.2, and assuming a baseline thrombosis incidence of 20%, 160 patients are required to detect an effect size of 15%.

Conditions

• Thrombosis

Interventions

Type	Name	Description
DRUG	Heparin sulfate infusion at 10 units/kg/hour	Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery
DRUG	Placebo infusion	Infusion of normal saline

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2008-10-24
• Last updated: 2015-06-12
• Results posted: 2015-06-12

Locations

1 site across 1 country: United States