Heparin and the Reduction of Thrombosis (HART) Trial

NCT ID: NCT00779558

Last Updated: 2015-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2007-11-30

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%.

Conditions

Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Study drug

Heparin sulfate infusion at 10 units/kg/hour

Group Type: ACTIVE_COMPARATOR

Heparin sulfate infusion at 10 units/kg/hour

Intervention Type: DRUG

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

Placebo

Placebo - normal saline infusion

Group Type: PLACEBO_COMPARATOR

Placebo infusion

Intervention Type: DRUG

Infusion of normal saline

Interventions

Heparin sulfate infusion at 10 units/kg/hour

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

Intervention Type: DRUG

Placebo infusion

Infusion of normal saline

Intervention Type: DRUG

Other Intervention Names

heparin

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Alan Schroeder

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen J. Roth M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20101197 (View on PubMed)

Other Identifiers

SU-11132007-879

Identifier Type: -

Identifier Source: org_study_id