NCT00246077

Brief Summary

This study is being done to see what impact having a Lifeport device has on quality of life for children with sickle cell who are getting chronic transfusions, from the child's perspective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2005

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

April 11, 2007

Status Verified

November 1, 2005

First QC Date

October 27, 2005

Last Update Submit

April 10, 2007

Conditions

Anemia, Sickle Cell

Keywords

chronic transfusion therapyquality of life

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Individuals with a diagnosis of sickle cell disease between the ages of 8 \& 18 years
  • currently receiving chronic transfusion therapy via a Lifeport device
  • Individuals have been utilizing the Lifeport for at least 6 months and no more than 18 months
  • Individuals have received transfusions previously using conventional transfusion therapy (simple or exchange transfusions)
  • Individuals have permission of parents (when applicable) and assent

You may not qualify if:

  • Individuals who, in the opinion of the study staff, would suffer negative consequence, psychosocial trauma, or undue stress as a result of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Susan Sarcone, RN

    Children's Mercy Hospital Kansas City

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 31, 2005

Study Start

October 1, 2005

Study Completion

December 1, 2005

Last Updated

April 11, 2007

Record last verified: 2005-11

Locations

US(1)