Clinical trial NCT00450151: Platelet Activation Markers in Pediatric Cardiac Surgery
Official title: Effect of Cardiopulmonary Bypass on Platelet Activation Markers Such as Platelet Factor 4 and Transforming Growth Factor B, in Pediatric Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Keywords: Pediatric
Cardiopulmonary bypass Surgery
Cardiac Surgery
Platelet
Platelet Activation Markers
Platelet Factor4
Transforming Growth Factor Beta
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2007-03-21
Enrollment: 10
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York City
country: United States
facility: NewYork-Presbyterian Hospital-Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College-New York Presbyterian Hospital
name: Aarti Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1136/heart.86.6.649.
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. doi: 10.1097/00000539-199902000-00006.
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. doi: 10.1097/00000542-199109000-00002.