Assessment of Pain in People With Thalassemia Who Are Treated With Regular Blood Transfusions
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|ClinicalTrials.gov Identifier: NCT00872833|
Recruitment Status : Completed
First Posted : March 31, 2009
Results First Posted : August 27, 2014
Last Update Posted : October 7, 2015
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|Official Title:||Assessment of Pain in Transfusion Dependent Patients With Thalassemia During Transfusion Cycles|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
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 [ Time Frame: measured daily over the 3 transfusion cycles ]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.
- Report of Pain by Length of the Transfusion Cycle [ Time Frame: measured daily over the 3 transfusion cycles ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872833
|United States, California|
|Children's Hospital of Los Angeles|
|Los Angeles, California, United States, 90027|
|Children's Hospital Research Center Oakland|
|Oakland, California, United States, 94609|
|Stanford University - School of Medicine|
|Stanford, California, United States, 94305|
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30342|
|United States, Illinois|
|Children's Memorial Hospital - Chicago|
|Chicago, Illinois, United States, 60614|
|United States, New York|
|Weill Medical College of Cornell|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|University Health Network - Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Dru Foote, NP||Children's Hospital and Research Institute Oakland|
|Study Chair:||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||Ann & Robert H Lurie Children's Hospital of Chicago|