An observational study in Thalassemia, sponsored by Carelon Research. Completed at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-07.
Sponsored by Carelon Research · Observational
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.
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, shortness of breath, and pain. There have been no previous research studies that have fully examined pain levels in people with thalassemia, and as a result, the sources of pain remain unknown. This study is a substudy of the Assessment of Pain study, which is a Thalassemia Clinical Research Network (TCRN) study that is examining the prevalence and severity of pain in people with transfusion-dependent thalassemia and non-transfusion-dependant thalassemia. This study will enroll a subset of participants from the Assessment of Pain study who have transfusion-dependant thalassemia. The purpose of this study is to examine whether pain varies during the blood transfusion cycle and whether the length of the transfusion cycle affects pain levels in people with transfusion-dependent thalassemia.
Participants will complete daily questionnaires through an automated telephone system to assess pain levels during three blood transfusion cycles. Each transfusion cycle will last between 2 to 4 weeks, depending on the individual needs of the participant, and the cycles will be separated by at least 3 months but no more than 4 months. Prior to each transfusion cycle, study researchers will review participants' medical records for certain blood level measurements.
422 studies on the registry are indexed under Thalassemia; 69 are open to participants now.
This study's enrollment of 32 is below the median of 100 across 122 observational studies indexed under Thalassemia.
Browse Thalassemia studies →Carelon Research is the lead sponsor of 59 studies on the registry; 4 are open to participants now.
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People with transfusion-dependent thalassemia who receive care at sites funded by the Thalassemia Clinical Research Network and their satellites.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
Report of Pain by Age Group
Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.
Time frame: measured daily over the 3 transfusion cycles
Report of Pain by Length of the Transfusion Cycle
Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.
Time frame: measured daily over the 3 transfusion cycles
| Milestone | Younger Cohort | Older Cohort |
|---|---|---|
| Started | 15 | 17 |
| Completed | 15 | 17 |
| Not completed | 0 | 0 |
Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.
| percentage of participant-cycles | Younger Cohort | Older Cohort |
|---|---|---|
| Start of cycle | 23 | 61 |
| 25% through cycle | 18 | 51 |
| 50% through cycle | 15 | 47 |
| 75% through cycle | 20 | 54 |
| End of cycle | 18 | 56 |
Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.
| percentage of participant-cycles | <= 14 Days | 15 - 21 Days | 22 - 28 Days | > 28 Days |
|---|---|---|---|---|
| Start of cycle | 50 | 40 | 42 | 41 |
| 25% through cycle | 50 | 48 | 35 | 14 |
| 50% through cycle | 50 | 48 | 23 | 14 |
| 75% through cycle | 60 | 52 | 31 | 18 |
| End of cycle | 50 | 44 | 31 | 32 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adverse Events Were Not Collected | — | — | — |
| Age, Continuous(years) | Overall |
|---|---|
| Mean | 31.8 ± 10.5 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 18 |
| Male | 14 |
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Carelon Research