Heparin and the Reduction of Thrombosis (HART) Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alan Schroeder, Stanford University
ClinicalTrials.gov Identifier:
NCT00779558
First received: October 22, 2008
Last updated: June 10, 2015
Last verified: June 2015
  Purpose

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?


Condition Intervention
Thrombosis
Drug: Heparin sulfate infusion at 10 units/kg/hour
Drug: Placebo infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Heparin and Catheter-related Thrombosis in Neonates and Infants Following Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Echocardiographic evidence of thrombosis while on study drug


Secondary Outcome Measures:
  • Total PRBCs Transfused [ Time Frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) ] [ Designated as safety issue: Yes ]
  • Days to Extubation [ Time Frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Need for Antibiotics [ Time Frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: November 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: heparin
Placebo Comparator: Placebo
Placebo - normal saline infusion
Drug: Placebo infusion
Infusion of normal saline

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%.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779558

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Stephen J. Roth M.D., M.P.H. Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alan Schroeder, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00779558     History of Changes
Other Study ID Numbers: SU-11132007-879
Study First Received: October 22, 2008
Results First Received: May 28, 2015
Last Updated: June 10, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 02, 2015