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

NCT00872833 | Completed Results DMC

• 2 other identifiers: 640U01HL065238
• Study Type: observational
• Target: 32
• Locations: 2 countries
• Sites: 9

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.

Conditions

Thalassemia

Keywords

Transfusion-Dependant Thalassemia; Pain; Mild Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Report of Pain by Length of the Transfusion Cycle

  measured daily over the 3 transfusion cycles

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Unwillingness or inability to complete the Brief Pain Inventory Short Form (BPI-SF) on a daily basis

Sponsors & Collaborators

• Carelon Research: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (9)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital Research Center Oakland

Oakland, California, 94609, United States

Location

Stanford University - School of Medicine

Stanford, California, 94305, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60614, United States

Location

Weill Medical College of Cornell

New York, New York, 10065, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Thalassemia; Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Eric Gerstenberger
• Organization: New England Research Institutes, Inc.

egerstenberger@neriscience.com

6179237747

Study Officials

• 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

  Ann & Robert H Lurie Children's Hospital of Chicago

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 7, 2015
• Results First Posted: August 27, 2014

Record last verified: 2012-04

Locations

US (8); CA (1)