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NCT00165906 · ClinicalTrials.gov registry record

Thrombin Generation in Neonates

A clinical trial of Blood Coagulation Disorders, sponsored by Emory University.

Completed
Registry status
20
Enrollment target
1
Study location

NCT00165906 is a study of Blood Coagulation Disorders that has completed, run by Emory University. The registered enrollment target is 20 participants, below the 260-participant average among 6 other Blood Coagulation Disorders trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00165906, a study of Blood Coagulation Disorders, has completed, sponsored by Emory University.

COMPLETED
Registry status
20 participants
Enrollment target
1
Study location

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.

Study Locations (1)

Georgia

  • Children's Healthcare of Atlanta at Egleston - Atlanta

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2005-01
Est. Completion 2009-01

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT00165906

The ClinicalTrials.gov registry entry for NCT00165906 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 260-participant average among 6 other Blood Coagulation Disorders trials with a reported enrollment target (92% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Blood Coagulation Disorders appearing as the primary indexed condition, and to 0 interventions.

NCT00165906 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT00165906 about?

NCT00165906 is a clinical study titled "Thrombin Generation in Neonates". 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...

What is the current status of trial NCT00165906?

This trial is currently completed. The enrollment target is 20 participants. The study started on 2005-01. Estimated completion is 2009-01.

What conditions does trial NCT00165906 study?

This clinical trial studies the following conditions: Blood Coagulation Disorders.

Who is sponsoring clinical trial NCT00165906?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00165906 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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