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?

Study Overview

• Status: Completed
• Conditions: Thrombosis
• Intervention / Treatment: Drug: Heparin sulfate infusion at 10 units/kg/hour; Drug: Placebo infusion

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%.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study drug; Heparin sulfate infusion at 10 units/kg/hour	Drug: Heparin sulfate infusion at 10 units/kg/hour; Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery; Other Names: heparin
Placebo Comparator: Placebo; Placebo - normal saline infusion	Drug: Placebo infusion; Infusion of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombosis	Echocardiographic evidence of thrombosis while on study drug	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 Outcome Measures

Outcome Measure	Time Frame
Total PRBCs Transfused	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)
Cardiac ICU Length of Stay	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)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Stephen J. Roth M.D., M.P.H., Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: October 22, 2008
• First Submitted That Met QC Criteria: October 23, 2008
• First Posted (Estimate): October 24, 2008

Study Record Updates

• Last Update Posted (Estimate): June 12, 2015
• Last Update Submitted That Met QC Criteria: June 10, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: SU-11132007-879