Heparin and the Reduction of Thrombosis (HART) Trial

Not Applicable

Completed

• Conditions: Thrombosis
• Interventions: Drug: Placebo infusion; Drug: Heparin sulfate infusion at 10 units/kg/hour

• Registration Number: NCT00779558
• Lead Sponsor: Stanford University

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%.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Results First Submitted: 2015-05-28
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-10
• Last Update Submitted: 2015-06-10
• Results First Posted: 2015-06-12
• Last Update Posted: 2015-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo infusion	Placebo - normal saline infusion
Study drug	Heparin sulfate infusion at 10 units/kg/hour	Heparin sulfate infusion at 10 units/kg/hour

Primary Outcome Measures

Name	Time	Method
Thrombosis	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 Outcome Measures

Name	Time	Method
Total PRBCs Transfused	While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
Need for Antibiotics	While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
Cardiac ICU Length of Stay	While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
Days to Extubation	While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States