Examining Cognitive Function and Brain Abnormalities in Adults With Sickle Cell Disease - Pilot Intervention Study
Neuropsychological Dysfunction and Neuroimaging Abnormalities in Neurologically Intact Adults With Sickle Cell Disease - A Pilot Intervention Study
3 other identifiers
interventional
36
1 country
14
Brief Summary
Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes and may lead to organ failure. Preliminary studies have shown that adults with SCD may have brain abnormalities that contribute to problems with cognitive functioning, including attention and memory difficulties. This study will use brain magnetic resonance imaging (MRI) and neuropsychological testing to examine the differences in cognitive functioning in adults with SCD who are treated for anemia with monthly blood transfusions for 6 months versus adults with SCD who receive usual care for 6 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2004
Longer than P75 for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 20, 2009
CompletedFirst Posted
Study publicly available on registry
February 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 15, 2017
February 1, 2017
6 years
February 20, 2009
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognitive function
Measured at Month 6
Study Arms (2)
1
EXPERIMENTALParticipants will receive monthly blood transfusions.
2
ACTIVE COMPARATORParticipants will receive usual care.
Interventions
Participants will receive blood transfusions at 3- to 4-week intervals for 6 months for the treatment of SCD-related anemia; the total number of transfusions that participants will receive will vary between six and eight.
Participants will receive usual care for the treatment of SCD.
Eligibility Criteria
You may qualify if:
- Completion of all components of the Phase 1 study (NCT00528801)
- Wechsler Adult Intelligence Scale (WAIS) III-Performance IQ (PIQ) score less than or equal to 90
- Hemoglobin less than or equal to 9.0 g/dL
- People who did not complete Phase I of the study are eligible for enrollment in this study if they meet all of the following criteria:
- Capable of giving informed consent for the study
- Willing to undergo transfusion therapy for 6 months
- African descent
- Proficient/fluent in English
- Hemoglobin electrophoresis confirming hemoglobin SS or SB0 (less than or equal to 15%)
- WAIS III-PIQ score less than or equal to 90
- Hemoglobin less than or equal to 9.0 g/dL
- Mini-Mental Status Examination (MMSE) score of greater than or equal to 20
- Profile of Mood States (POMS) score on the Depression-Dejection Subscale less than or equal to 40
You may not qualify if:
- People who meet any of the following criteria are disqualified from enrollment in this study:
- History of life threatening or serious transfusion complications
- Lack of venous access
- Current enrollment in the Arginine study (NCT00513617)
- Pregnant
- Refusal of transfusion
- History of unexplained severe hemolytic transfusion reaction
- History of serious allergic, pulmonary transfusion reaction requiring hospitalization
- Positive auto-immune hemolytic anemia (direct Coombs test with IgG and complement)
- Multiple (three or more) clinically significant allo-antibodies, due to common antigens (e.g., EC, Kel)
- Uncommon, clinically significant antibody that results in difficulty in finding matched units (e.g., anti-JKB)
- Currently taking Hydroxyurea and not on a stable dose in the 6 months before study entry
- Creatinine level greater than 1.7 mg/dL
- Major infarct identified on Phase I MRI
- Currently on Procrit or related drug that stimulates red blood cell production
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Children's Hospital & Research Center at Oakland
Oakland, California, 94609, United States
Howard University
Washington D.C., District of Columbia, 20001, United States
Memorial Cancer Institute
Hollywood, Florida, 33021, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Johns Hopkins
Baltimore, Maryland, 94117, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Karmanos Cancer Institute at Wayne State University
Detroit, Michigan, 48201, United States
Washington University
St Louis, Missouri, 63110, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229-3039, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elliott Vichinsky, MD
UCSF Benioff Children's Hospital Oakland
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 20, 2009
First Posted
February 24, 2009
Study Start
December 1, 2004
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 15, 2017
Record last verified: 2017-02