Clinical trial NCT00779558: Heparin and the Reduction of Thrombosis (HART) Trial
Official title: Heparin and Catheter-related Thrombosis in Neonates and Infants Following Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thrombosis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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%.

Eligibility criteria: Inclusion Criteria:

* All infants \< 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital \& #xA

Exclusion Criteria:

* Known coagulopathy
* History of clinically significant bleeding (GI, cranial, pulmonary)
* Need for therapeutic heparinization
* ECMO

Primary outcomes:
measure: Thrombosis
timeFrame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days
Secondary outcomes:
measure: Total PRBCs Transfused
timeFrame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
measure: Days to Extubation
timeFrame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
measure: Cardiac ICU Length of Stay
timeFrame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
measure: Need for Antibiotics
timeFrame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Stephen J. Roth M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schroeder AR, Axelrod DM, Silverman NH, Rubesova E, Merkel E, Roth SJ. A continuous heparin infusion does not prevent catheter-related thrombosis in infants after cardiac surgery. Pediatr Crit Care Med. 2010 Jul;11(4):489-95. doi: 10.1097/PCC.0b013e3181ce6e29.