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Heparin and the Reduction of Thrombosis (HART) Trial

This study has been completed.
Sponsor:
Collaborator:
Pediatric Health Reserach Award
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00779558
First received: October 22, 2008
Last updated: October 23, 2008
Last verified: October 2008

October 22, 2008
October 23, 2008
November 2005
Not Provided
Thrombosis
Same as current
Complete list of historical versions of study NCT00779558 on ClinicalTrials.gov Archive Site
  • Number of blood transfusions
  • Days to extubation
  • Cardiac ICU length of stay
  • Need for antibiotics
  • Laboratory values (coagulation studies and blood counts)
  • Chest tube output
Same as current
Not Provided
Not Provided
 
Heparin and the Reduction of Thrombosis (HART) Trial
Heparin and Catheter-Related Thrombosis in Neonates and Infants Following Cardiac Surgery

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?

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%.

There are currently 96 patients enrolled.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Thrombosis
Drug: Heparin sulfate infusion
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
November 2007
Not Provided

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
Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00779558
SU-11132007-879
Not Provided
Not Provided
Stanford University
Pediatric Health Reserach Award
Principal Investigator: Stephen J. Roth M.D., M.P.H. Stanford University
Stanford University
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP