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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL065238 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| age 18-29 | 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. | ||
| age 30+ | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | measured daily over the 3 transfusion cycles |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | measured daily over the 3 transfusion cycles |
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Inclusion Criteria:
Exclusion Criteria:
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People with transfusion-dependent thalassemia who receive care at sites funded by the Thalassemia Clinical Research Network and their satellites.
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| Name | Affiliation | Role |
|---|---|---|
| Dru Foote, NP | Children's Hospital and Research Institute Oakland | Principal Investigator |
| Jeanne Boudreaux, MD | Children's Healthcare of Atlanta | Study Chair |
| Thomas Coates, MD | Children's Hospital Los Angeles | Study Chair |
| Elliott Vichinsky, MD | UCSF Benioff Children's Hospital Oakland | Study Chair |
| Michael Jeng, MD | Stanford University | Study Chair |
| Janet Kwiatkowski, MD | Children's Hospital of Philadelphia | Study Chair |
| Nancy Olivieri, MD | University Health Network - Toronto General Hospital | Study Chair |
| Patricia J. Giardina, MD | Weill Medical College of Cornell | Study Chair |
| Brigitta Mueller, MD | Baylor College of Medicine | Study Chair |
| Alexis A. Thompson, MD, MPH |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| Children's Hospital Research Center Oakland |
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| ID | Title | Description |
|---|---|---|
| FG000 | Younger Cohort | 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. |
| FG001 | Older Cohort | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Both cohorts combined |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of participant-cycles | measured daily over the 3 transfusion cycles | Participant-cycles | Participants |
|
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Adverse event data were not collected for this observational study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adverse Events Were Not Collected | Adverse events were not collected as part of this observational study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Gerstenberger | New England Research Institutes, Inc. | 6179237747 | egerstenberger@neriscience.com |
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| ID | Term |
|---|---|
| D013789 | Thalassemia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| Ann & Robert H Lurie Children's Hospital of Chicago |
| Study Chair |
| Oakland |
| California |
| 94609 |
| United States |
| Stanford University - School of Medicine | Stanford | California | 94305 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30342 | United States |
| Children's Memorial Hospital - Chicago | Chicago | Illinois | 60614 | United States |
| Weill Medical College of Cornell | New York | New York | 10065 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University Health Network - Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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|
|
| Secondary | 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. | Unit of analysis was participant-cycle. Data were collected over (at most) three transfusion cycles for each subject. Transfusion cycle lengths varied, and subjects may be represented in more than one arm/group. | Posted | Number | percentage of participant-cycles | measured daily over the 3 transfusion cycles | Participant-cycles | Participants |
|
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|
|
| 0 |
| 0 |
| 0 |
| 0 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Participant-cycles |
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| 25% through cycle |
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| 50% through cycle |
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| 75% through cycle |
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| End of cycle |
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