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Thrombin Generation in Neonates

NCT00165906 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2013-11-21

No results posted yet for this study

Summary

Children having open heart surgery must be on a heart-lung bypass machine. It is essential that the blood in the heart-lung machine does not clot. This is accomplished by giving a drug called heparin, a "blood thinner".

The process of making a clot involves a lot of steps. One of the steps involves a protein called thrombin. Heparin acts on thrombin to keep blood from clotting. A technique has been developed to measure the blood's ability to generate thrombin. The bloods's ability to generate thrombin is measured by a thrombin generation curve (TGC). This curve would be very helpful to know when choosing the dose of heparin. We haven't found any studies using TGC in babies less than a month old.

We want to do a study comparing the TGC in 10 newborns without a heart defect to the TGC in 10 newborns with a congenital heart defect. To do this we will need one sample of blood. the sample we need is 3 cc which is a little more than 1/2 teaspoon. The blood sample for both groups is to be taken from the intravenous catheter (IV) the child will have placed for surgery. The newborns without a heart defect will be children having surgery for a non-cardiac problem.

Conditions

  • Blood Coagulation Disorders

Sponsors & Collaborators

  • Children's Healthcare of Atlanta

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Nina A Guzzetta, MD · Emory University

Eligibility

Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00165906 on ClinicalTrials.gov