Assessment of Pain in People With Thalassemia Who Are Treated With Regular Blood Transfusions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00872833
First received: March 30, 2009
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

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
Thalassemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Pain in Transfusion Dependent Patients With Thalassemia During Transfusion Cycles

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Assess whether reports of pain vary over the transfusion cycle [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess whether the length of the transfusion cycle affects pain level [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Assess whether pain varies by pre-transfusion hemoglobin and reticulocyte levels [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: July 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
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.
2
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People with transfusion-dependent thalassemia who receive care at sites funded by the Thalassemia Clinical Research Network and their satellites.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872833

Locations
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
Canada, Ontario
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Investigators
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 Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00872833     History of Changes
Other Study ID Numbers: 640, U01 HL065238
Study First Received: March 30, 2009
Last Updated: April 30, 2012
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Transfusion-Dependant Thalassemia
Pain
Mild Pain

Additional relevant MeSH terms:
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 21, 2014