Quality of Life of Children With Sickle Cell Disease Who Are Receiving Chronic Transfusion Therapy With a Lifeport Device
Quality of Life of Children With Sickle Cell Disease Who Are Getting Chronic Transfusions With a Lifeport
Sponsors
Source
Children's Mercy Hospital Kansas City
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.
Detailed 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.
Overall Status
Completed
Start Date
2005-10-01
Completion Date
2005-12-01
Primary Completion Date
N/A
Study Type
Observational
Enrollment
5
Condition
Eligibility
Criteria
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
Gender
All
Minimum Age
8 Years
Maximum Age
18 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Susan Sarcone, RN |
Study Director |
The Children's Mercy Hospital |
Location
Facility |
|
The Children's Mercy Hospital Kansas City Missouri 64108 United States |
Location Countries
Country
United States
Verification Date
2005-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Keywords
Has Expanded Access
No
Condition Browse
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Time Perspective
Cross-Sectional, Retrospective
Study First Submitted
October 27, 2005
Study First Submitted Qc
October 27, 2005
Study First Posted
October 31, 2005
Last Update Submitted
April 10, 2007
Last Update Submitted Qc
April 10, 2007
Last Update Posted
April 11, 2007
ClinicalTrials.gov processed this data on October 05, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.