NCT00165906

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

4 years

First QC Date

September 9, 2005

Last Update Submit

November 19, 2013

Conditions

Blood Coagulation Disorders

Keywords

neonatescardiacnon-cardiacsurgeryanticoagulation

Eligibility Criteria

AgeUp to 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study patients will be obtained from Children's Healthcare of Atlanta at Egleston. The study patients will be in the pre-operative clinic, Cardiac Intensive Care Unit or the Cardiac Stepdown Unit.

You may qualify if:

  • Patients undergoing elective cardiac surgery scheduled at Children's Healthcare of Atlanta as a first time procedure OR patients undergoing elective non-cardiac surgery scheduled at Children's Healthcare of Atlanta (control group)
  • Patients within the appropriate age group, i.e. less than 1 month old
  • Parents or legal guardian willing for the child to participate and able to sign the provided informed consent -

You may not qualify if:

  • Patients undergoing any emergent procedure/surgery
  • Patients who are being administered preoperative anticoagulant therapy
  • Patients with a known coagulation defect or coagulopathy
  • Patients who are premature, i.e. less than 37 weeks gestational age
  • Patient who are greater than 1 month of age
  • Parents or legal guardian are unwilling or unable to sign the provided informed consent
  • Patients who in the opinion of the investigators should not be included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

  • Kern FH, Morana NJ, Sears JJ, Hickey PR. Coagulation defects in neonates during cardiopulmonary bypass. Ann Thorac Surg. 1992 Sep;54(3):541-6. doi: 10.1016/0003-4975(92)90451-9.

    PMID: 1510523BACKGROUND

  • Guzzetta NA, Miller BE, Todd K, Szlam F, Moore RH, Tosone SR. An evaluation of the effects of a standard heparin dose on thrombin inhibition during cardiopulmonary bypass in neonates. Anesth Analg. 2005 May;100(5):1276-1282. doi: 10.1213/01.ANE.0000149590.59294.3A.

    PMID: 15845669BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

A blood sample is obtained to measure the thrombin level.

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Nina A Guzzetta, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

January 1, 2005

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

US(1)