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Heparin and the Reduction of Thrombosis (HART) Trial

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ClinicalTrials.gov Identifier: NCT00779558
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : June 12, 2015
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
Alan Schroeder, 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?

Condition or disease Intervention/treatment Phase
Thrombosis Drug: Heparin sulfate infusion at 10 units/kg/hour Drug: Placebo infusion Not Applicable

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  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Heparin and Catheter-related Thrombosis in Neonates and Infants Following Cardiac Surgery
Study Start Date : November 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine


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 Name: heparin

Placebo Comparator: Placebo
Placebo - normal saline infusion
Drug: Placebo infusion
Infusion of normal saline




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 24, 2008    Key Record Dates
Results First Posted: June 12, 2015
Last Update Posted: June 12, 2015
Last Verified: June 2015

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