N/A
N=32
Assessment of Pain in People With Thalassemia Who Are Treated With Regular Blood Transfusions
Thalassemia
Bottom Line
View on ClinicalTrials.gov: NCT00872833 ↗Enrolled (actual)
32
Serious AEs
—
Results posted
Aug 2014
Primary outcome: Primary: Report of Pain by Age Group — 23; 61; 18; 51 percentage of participant-cycles — p=<.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Carelon Research
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Report of Pain by Age Group |
23; 61; 18; 51; 15; 47 | <.001 sig |
| SECONDARY Report of Pain by Length of the Transfusion Cycle |
50; 40; 42; 41; 50; 48 | 0.028 sig |
Summary
Thalassemia is an inherited blood disorder that can result in mild to severe anemia. Regular blood transfusions, which refresh the healthy red blood cell supply, are one treatment for thalassemia. People with thalassemia often experience pain, but the exact source of pain remains unknown. This study will examine how pain varies during the blood transfusion cycle in people with thalassemia who are treated with regular blood transfusions.
Eligibility Criteria
Inclusion Criteria
- Participating in the Thalassemia Clinical Research Network Assessment of Pain study
- Has a transfusion dependence of at least eight transfusions per year
- Diagnosis of beta thalassemia or E-beta-thalassemia
- Experiences at least "mild" pain in the 1 month before study entry, as measured by the response to the Brief Pain Inventory (BPI) question #6 from the Assessment of Pain study
Exclusion Criteria
- Unwillingness or inability to complete the Brief Pain Inventory Short Form (BPI-SF) on a daily basis
Data sourced from ClinicalTrials.gov (NCT00872833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.