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

Thalassemia Clinical Trial

Official title:

Assessment of Pain in Transfusion Dependent Patients With Thalassemia During Transfusion Cycles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872833
• Other study ID #: 640
• Secondary ID: U01HL065238
• Status: Completed
• Phase: N/A
• First received: March 30, 2009
• Last updated: October 5, 2015
• Start date: July 2009
• Est. completion date: October 2010

Study information

• Verified date: April 2012
• Source: New England Research Institutes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thalassemia

Locations

Country	Name	City	State
Canada	University Health Network - Toronto General Hospital	Toronto	Ontario
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Children's Memorial Hospital - Chicago	Chicago	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	Weill Medical College of Cornell	New York	New York
United States	Children's Hospital Research Center Oakland	Oakland	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Stanford University - School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
New England Research Institutes	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Report of Pain by Length of the Transfusion Cycle	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	No