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

History of Changes

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:

MedlinePlus related topics: Coronary Artery Disease Heart Surgery

U.S. FDA Resources

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

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:

Garlichs CD, Eskafi S, Raaz D, Schmidt A, Ludwig J, Herrmann M, Klinghammer L, Daniel WG, Schmeisser A. Patients with acute coronary syndromes express enhanced CD40 ligand/CD154 on platelets. Heart. 2001 Dec;86(6):649-55.

Ichinose F, Uezono S, Muto R, Uchida H, Hatori F, Terui K, Niimi Y, Goto T, Nakata Y, Morita S. Platelet hyporeactivity in young infants during cardiopulmonary bypass. Anesth Analg. 1999 Feb;88(2):258-62.

Rinder CS, Bohnert J, Rinder HM, Mitchell J, Ault K, Hillman R. Platelet activation and aggregation during cardiopulmonary bypass. Anesthesiology. 1991 Sep;75(3):388-93.

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 Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

Mitogens
Platelet Factor 4
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013

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