Platelet Activation Markers in Pediatric Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aarti Sharma, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00450151
First received: March 20, 2007
Last updated: February 29, 2012
Last verified: February 2012

March 20, 2007
February 29, 2012
February 2007
February 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00450151 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Platelet Activation Markers in Pediatric Cardiac Surgery
Effect of Cardiopulmonary Bypass on Platelet Activation Markers Such as Platelet Factor 4 and Transforming Growth Factor B, in Pediatric Cardiac Surgery

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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.

Non-Probability Sample

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.

Coronary Disease
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
February 2009
February 2009   (final data collection date for primary outcome measure)

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

Both
up to 7 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00450151
0612008895
No
Aarti Sharma, Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Aarti Sharma, MD Weill Medical College-New York Presbyterian Hospital
Weill Medical College of Cornell University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP