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The Link Between Anemia and Deficits in Memory and Attention in Individuals With Sickle Cell Disease

Primary Purpose

Sickle Cell Disease

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Sickle Cell Disease focused on measuring MRI, Neuropsychology

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of sickle cell disease

Exclusion Criteria:

  • Pregnancy
  • Claustrophobia
  • Mass lesion (e.g., meningioma, cyst, or spinal block)
  • Need for life support constant monitoring
  • Any unstable condition that is likely to require resuscitation
  • Presence of a pacemaker or other iron-containing magnetic substances in the body

Sites / Locations

  • University of California San Francisco

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 23, 2007
Last Updated
August 18, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00451919
Brief Title
The Link Between Anemia and Deficits in Memory and Attention in Individuals With Sickle Cell Disease
Official Title
Sickle-Cell Disease: Neuroimaging and Cognitive Decline
Study Type
Observational

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
University of California, San Francisco

4. Oversight

5. Study Description

Brief Summary
Sickle cell disease is an inherited blood disorder that affects red blood cells (RBCs). People with sickle cell disease frequently experience anemia, or a low number of RBCs. RBCs are responsible for carrying oxygen to the brain and other body tissues that need oxygen to function properly. The purpose of this study is to determine what changes, which were possibly caused by anemia, exist in the brains of individuals with sickle cell disease.
Detailed Description
The role of RBCs is to carry oxygen from the lungs to the brain and other body tissues. Individuals with anemia have unusually low numbers of RBCs. They also often have difficulty concentrating and remembering information, which is likely caused by a reduced oxygen supply to the brain. Previous research has shown that correcting anemia in patients without sickle cell disease improved their memory and attention. The purpose of this study is to examine any abnormal changes in the brains of individuals with sickle cell disease and to determine whether these changes are related to reduced memory and attention capabilities. Participants will attend one study visit. During this visit, a brain magnetic resonance image (MRI) will be performed while participants complete neuropsychological tests that measure memory, attention, and organizational ability. There will be no follow-up visits. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
MRI, Neuropsychology

7. Study Design

Enrollment
120 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of sickle cell disease Exclusion Criteria: Pregnancy Claustrophobia Mass lesion (e.g., meningioma, cyst, or spinal block) Need for life support constant monitoring Any unstable condition that is likely to require resuscitation Presence of a pacemaker or other iron-containing magnetic substances in the body
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall R. Rule, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

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The Link Between Anemia and Deficits in Memory and Attention in Individuals With Sickle Cell Disease

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