Platelet Activation Markers in Pediatric Cardiac Surgery

Coronary Disease Clinical Trial

Official title:

Effect of Cardiopulmonary Bypass on Platelet Activation Markers Such as Platelet Factor 4 and Transforming Growth Factor B, in Pediatric Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00450151
• Other study ID #: 0612008895
• Status: Completed
• Phase: N/A
• First received: March 20, 2007
• Last updated: February 29, 2012
• Start date: February 2007
• Est. completion date: February 2009

Study information

• Verified date: February 2012
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Locations

Country	Name	City	State
United States	NewYork-Presbyterian Hospital-Weill Cornell Medical College	New York City	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation