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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00872833 |
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.
Condition |
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Thalassemia |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Assessment of Pain in Transfusion Dependent Patients With Thalassemia During Transfusion Cycles |
Estimated Enrollment: | 25 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
People with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
People with transfusion-dependent thalassemia who receive care at sites funded by the Thalassemia Clinical Research Network and their satellites.
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Virzi, MS, MBA | 617-923-7747 ext 258 | lvirzi@neriscience.com |
United States, California | |
Children's Hospital of Los Angeles | Recruiting |
Los Angeles, California, United States, 90027 | |
Contact: Susan Carson, NP 323-361-4132 SCarson@chla.usc.edu | |
Principal Investigator: Tom Coates, MD | |
Children's Hospital Research Center Oakland | Recruiting |
Oakland, California, United States, 94609 | |
Contact: Nancy Sweeters, NP 510-428-3885 ext x4151 NSweeters@mail.cho.org | |
Principal Investigator: Elliott Vichinsky, MD | |
Stanford University - School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Micheal Jeng, MD 650-723-5535 mjeng@leland.stanford.edu | |
Principal Investigator: Michael Jeng, MD | |
United States, Georgia | |
Children's Healthcare of Atlanta | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Leann Hassen 404-785-2025 Leann.Hassen@choa.org | |
Principal Investigator: Jeanne Boudreaux, MD | |
United States, Illinois | |
Children's Memorial Hospital - Chicago | Recruiting |
Chicago, Illinois, United States, 60614 | |
Contact: Diane Calamaras, RN 773-868-8953 dcalamaras@childrensmemorial.org | |
Principal Investigator: Alexis Thompson, MD | |
United States, New York | |
Weill Medical College of Cornell | Recruiting |
New York, New York, United States, 10065 | |
Contact: Dorothy Kleinert, RN 212-746-3404 dok2001@med.cornell.edu | |
Principal Investigator: Patricia Giardina, MD, MPH | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Sage Green 267-426-5602 greenst1@email.chop.edu | |
Principal Investigator: Janet Kwiatkowski, MD | |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Bogdan Dinu, MD 832-824-4825 brdinu@txccc.org | |
Principal Investigator: Brigitta Mueller, MD | |
Canada, Ontario | |
University Health Network - Toronto General Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2C4 | |
Contact: Cecilia Kim 416-340-3979 cecilia.kim@uhn.on.ca | |
Principal Investigator: Nancy Olivieri, MD |
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 | Children's Hospital & Research Center Oakland |
Study Chair: | Michael Jeng, MD | Stanford University |
Study Chair: | Janet Kwiatkowski, MD | Children's Hospital 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 | Children's Memorial Hospital |
Responsible Party: | New England Research Institutes ( Sonja McKinlay, PhD ) |
Study ID Numbers: | 640, U01 HL065238 |
Study First Received: | March 30, 2009 |
Last Updated: | July 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00872833 History of Changes |
Health Authority: | United States: Federal Government |
Transfusion-Dependant Thalassemia Pain Mild Pain |
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies Anemia |
Anemia, Hemolytic Pain Hemoglobinopathy Thalassemia |
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies |
Anemia Anemia, Hemolytic Thalassemia |