NCT00450151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

March 1, 2012

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

March 20, 2007

Last Update Submit

February 29, 2012

Conditions

Coronary Disease

Keywords

PediatricCardiopulmonary bypass SurgeryCardiac SurgeryPlateletPlatelet Activation MarkersPlatelet Factor4Transforming Growth Factor Beta

Eligibility Criteria

AgeUp to 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Patients scheduled to have surgery involving cardiopulmonary bypass for congenital cardiac abnormalities.
  • Age: Newborn to 7 years
  • Gender: male and female

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NewYork-Presbyterian Hospital-Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related 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. doi: 10.1136/heart.86.6.649.

    PMID: 11711459BACKGROUND

  • 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.

    PMID: 9972737BACKGROUND

  • 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.

    PMID: 1716077BACKGROUND

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.

MeSH Terms

Conditions

Coronary DiseaseCamurati-Engelmann Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesOsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Aarti Sharma, MD

    Weill Medical College-New York Presbyterian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 21, 2007

Study Start

February 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

March 1, 2012

Record last verified: 2012-02

Locations

US(1)