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Platelet Activation Markers in Pediatric Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00450151
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : March 1, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
In this study the focus will be on correlating the levels of platelet activation markers (proteins that are released when blood cells are activated)to the duration of cardiopulmonary bypass, temperature during cardiopulmonary bypass and the weight of the patient.

Condition or disease
Coronary Disease

Detailed Description:

This research is being done because we would like to learn more about platelet dysfunction in children undergoing cardiopulmonary bypass.

It has been an established fact that cardiopulmonary bypass causes dysfunction in platelets. Activation of platelets during cardiopulmonary bypass is implicated as being a major factor in causing platelet dysfunction.

For all participants, approximately 3.15 ml of blood will be collected in special tubes called CTAD tubes, before and after cardiopulmonary bypass (6.30ml in total). This amount of blood draw is well within the guidelines of NIH (National Institute of Health).

Enzyme-linked immunosorbent assay (ELISA) will be performed using this plasma to make quantitative assessment of Platelet factor 4 and Transforming growth factor beta.

Study Design

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Cardiopulmonary Bypass on Platelet Activation Markers Such as Platelet Factor 4 and Transforming Growth Factor B, in Pediatric Cardiac Surgery
Study Start Date : February 2007
Primary Completion Date : February 2009
Study Completion Date : February 2009
Groups and Cohorts

Outcome Measures

Biospecimen Retention:   Samples Without DNA
For all patients, after obtaining written consent, 3.15ml of blood will be collected in CTAD tubes, from arterial line pre cardiopulmonary bypass and post cardiopulmonary bypass. Blood sample will be cooled in ice bath, centrifuged at 2500 rpm for 30 minutes, and supernatant plasma sample will be collected. This plasma will be stored at -20 degrees celcius or below. Enzyme-linked immunosorbent assay (ELISA) will be performed using the plasma to make quantitative assessment of platelet factor 4 and transforming growth factor beta.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The targeted population will be pediatric patients with congenital heart defects who will be needing cardiopulmonary bypass (CPB) while undergoing cardiac surgery. The age range will be newborn to 7 years of age.

Inclusion Criteria:

  • Patients scheduled to have surgery involving cardiopulmonary bypass for congenital cardiac abnormalities.
  • Age: Newborn to 7 years
  • Gender: male and female

Exclusion Criteria:

  • Emergency surgery
  • Weight less than 3 kg
  • Age greater than 7 years
  • Patients with low platelet counts (<100,000)
  • Patients on medications that are known to interfere with platelet function such as prostacyclins, non-steroidal anti-inflammatory drugs, plavix.

Patients whose parents not willing to give consent

Contacts and Locations

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): NCT00450151

United States, New York
NewYork-Presbyterian Hospital-Weill Cornell Medical College
New York City, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Principal Investigator: Aarti Sharma, MD Weill Medical College-New York Presbyterian Hospital
More Information

Responsible Party: Aarti Sharma, Associate Professor of Anesthesiology, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00450151     History of Changes
Other Study ID Numbers: 0612008895
First Posted: March 21, 2007    Key Record Dates
Last Update Posted: March 1, 2012
Last Verified: February 2012

Keywords provided by Aarti Sharma, Weill Medical College of Cornell University:
Cardiopulmonary bypass Surgery
Cardiac Surgery
Platelet Activation Markers
Platelet Factor4
Transforming Growth Factor Beta

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Platelet Factor 4