Quality of Life of Children With Sickle Cell Disease Who Are Getting Chronic Transfusions With a Lifeport

Anemia, Sickle Cell Clinical Trial

Official title:

Quality of Life of Children With Sickle Cell Disease Who Are Receiving Chronic Transfusion Therapy With a Lifeport Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246077
• Other study ID #: CMH 05 07-098E
• 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
• 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

• Anemia, Sickle Cell

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,