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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
Results First Received: May 28, 2015  
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
Condition: Thrombosis
Interventions: Drug: Heparin sulfate infusion at 10 units/kg/hour
Drug: Placebo infusion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Study Drug

Heparin sulfate infusion at 10 units/kg/hour

Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery

Placebo Placebo - normal saline infusion

Participant Flow:   Overall Study
    Study Drug   Placebo
STARTED   57   44 
COMPLETED   53   37 
NOT COMPLETED   4   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Study Drug

Heparin sulfate infusion at 10 units/kg/hour

Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery

Placebo Placebo - normal saline infusion
Total Total of all reporting groups

Baseline Measures
   Study Drug   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   37   90 
Age 
[Units: Months]
Mean (Standard Deviation)
 4.1  (2.7)   4.3  (3.2)   4.2  (3) 
Gender 
[Units: Participants]
     
Female   24   14   38 
Male   29   23   52 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   3   4   7 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   2   0   2 
White   43   31   74 
More than one race   4   2   6 
Unknown or Not Reported   0   0   0 


  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Total PRBCs Transfused   [ Time Frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) ]

3.  Secondary:   Days to Extubation   [ Time Frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) ]

4.  Secondary:   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) ]

5.  Secondary:   Need for Antibiotics   [ Time Frame: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alan Schroeder
Organization: Stanford University
phone: 408 885-5260
e-mail: alan.schroeder@hhs.sccgov.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alan Schroeder, 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