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

NCT ID: NCT00872833

Last Updated: 2015-10-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-10-31

Brief Summary

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.

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.

Conditions

Thalassemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Carelon Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dru Foote, NP

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital and Research Institute Oakland

Jeanne Boudreaux, MD

Role: STUDY_CHAIR

Children's Healthcare of Atlanta

Thomas Coates, MD

Role: STUDY_CHAIR

Children's Hospital Los Angeles

Elliott Vichinsky, MD

Role: STUDY_CHAIR

UCSF Benioff Children's Hospital Oakland

Michael Jeng, MD

Role: STUDY_CHAIR

Stanford University

Janet Kwiatkowski, MD

Role: STUDY_CHAIR

Children's Hospital of Philadelphia

Nancy Olivieri, MD

Role: STUDY_CHAIR

University Health Network - Toronto General Hospital

Patricia J. Giardina, MD

Role: STUDY_CHAIR

Weill Medical College of Cornell

Brigitta Mueller, MD

Role: STUDY_CHAIR

Baylor College of Medicine

Alexis A. Thompson, MD, MPH

Role: STUDY_CHAIR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

Children's Hospital of Los Angeles

Los Angeles, California, United States

Children's Hospital Research Center Oakland

Oakland, California, United States

Stanford University - School of Medicine

Stanford, California, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Children's Memorial Hospital - Chicago

Chicago, Illinois, United States

Weill Medical College of Cornell

New York, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

U01HL065238

Identifier Type: NIH

Identifier Source: secondary_id

View Link

640

Identifier Type: -

Identifier Source: org_study_id