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
  Purpose

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
Coronary Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

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.


Enrollment: 10
Study Start Date: February 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 7 Years
Genders Eligible for Study:   Both
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.

Criteria

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
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: NCT00450151

Locations
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
Investigators
Principal Investigator: Aarti Sharma, MD Weill Medical College-New York Presbyterian Hospital
  More Information

Publications:
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
Study First Received: March 20, 2007
Last Updated: February 29, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Mitogens
Platelet Factor 4
Coagulants
Hematologic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014