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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00246077
Other study ID # CMH 05 07-098E
Secondary ID
Status Completed
Phase N/A
First received October 27, 2005
Last updated April 10, 2007
Start date October 2005
Est. completion date December 2005

Study information

Verified date November 2005
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

There is a paucity of research that focuses specifically on quality of life (QoL) among patients with sickle cell. This study aims to explore the QoL of children who are receiving chronic transfusion therapy (CTT) using a Lifeport device, which allows them to undergo erythrocytapheresis, rather than standard transfusion therapy. Erythrocytapheresis is less time consuming and is associated with less iron overload than conventional transfusion therapy; however, little is known about the implications for the child's QoL. This study will explore QoL from the child's perspective.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 18 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

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

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States The Children's Mercy Hospital Kansas City Missouri

Sponsors (1)

Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

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