Status:
COMPLETED
Assessment of Pain in People With Thalassemia
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Thalassemia
Eligibility:
All Genders
12-90 years
Brief Summary
Thalassemia is an inherited blood disorder that can result in mild to severe anemia. People with thalassemia often experience pain, but the exact sources and prevalence of pain remain unknown. This st...
Detailed Description
Thalassemia is an inherited blood disorder in which the body makes an abnormal form of hemoglobin-the protein in red blood cells that carries oxygen. People with thalassemia often experience fatigue, ...
Eligibility Criteria
Inclusion
- Thalassemia, as documented by clinical diagnosis, including the following:
- B-thalassemia (intermedia or major)
- Hgb H disease
- Hgb H with non-deletional mutations (e.g., Hgb H Constant Spring)
- E-B-thalassemia
- Homozygous alpha thalassemia
- Other thalassemic conditions not explicitly excluded
- Thalassemia intermedia due to heterozygous B mutation with an alpha excess
- Participants can be of any race, ethnicity, and either gender.
Exclusion
- Thalassemia trait (i.e., single recessive B gene mutation, 2 gene alpha mutation) and thalassemia Hgb S, C, or D compound heterozygotes
- Unwillingness or inability to complete the Brief Pain Inventory (BPI) on a quarterly basis
- Has had a successful bone marrow transplant
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT00872339
Start Date
March 1 2009
End Date
December 1 2010
Last Update
June 5 2014
Active Locations (8)
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1
Children's Hospital and Research Institute at Oakland
Oakland, California, United States, 94609
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
3
Children's Memorial Hospital of Chicago
Chicago, Illinois, United States, 60614
4
Children's Hospital of Boston
Boston, Massachusetts, United States, 02115