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Completed

NCT Number: NCT00779558

Heparin and the Reduction of Thrombosis (HART) Trial

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?

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Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heparin sulfate infusion at 10 units/kg/hour

Drug

Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery

Other names: heparin

placebo infusion

Drug

Infusion of normal saline

Primary outcomes

  1. Thrombosis

    Time frame: 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

    Echocardiographic evidence of thrombosis while on study drug

Secondary outcomes

  1. Total PRBCs Transfused

    Time frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)

  2. Days to Extubation

    Time frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)

  3. Cardiac ICU Length of Stay

    Time frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)

  4. Need for Antibiotics

    Time frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 24, 2008
Registry last updated
Jun 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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