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Clinical Trials/NCT00450151
NCT00450151CompletedNot Applicable

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

Weill Medical College of Cornell University1 site in 1 country10 target enrollmentStarted: February 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1

Study Overview

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.

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
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aarti Sharma

Associate Professor of Anesthesiology

Weill Medical College of Cornell University

Study Sites (1)

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