NCT00906906

Brief Summary

The purpose of this study is to characterize blood flow in the plastic tubing of a heart-lung bypass machine during heart surgery. Technical specifications provided by the manufacturer do not consider varying hemodynamic conditions such as temperature and hemoglobin levels which affect blood viscosity and ultimately blood flow to and from the patient during heart-lung bypass. The investigator wishes to perform a prospective study of the heart-lung bypass tubing in children that require heart-lung bypass during heart surgery.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2009

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

May 19, 2009

Last Update Submit

January 21, 2025

Conditions

Cardiopulmonary Bypass

Study Arms (1)

1

Patient to receive CPB

Device: Doppler probes

Interventions

Doppler probesDEVICE

Probes to be placed on CPB tubing to measure blood flow

1

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children who undergo heart-lung bypass during surgical correction of their congenital or acquired heart disease.

You may qualify if:

  • All Patients that require cardiopulmonary bypass during cardiac surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Study Officials

  • Richard Ginther, CCP

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 21, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

June 30, 2009

Last Updated

January 24, 2025

Record last verified: 2025-01

Locations

US(1)