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Assessment of Pain in People With Thalassemia Who Are Treated With Regular Blood Transfusions
This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), July 2009
First Received: March 30, 2009   Last Updated: July 10, 2009   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00872833
  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: Cohort, 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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
1
People 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872833

Contacts
Contact: Lisa Virzi, MS, MBA 617-923-7747 ext 258 lvirzi@neriscience.com

Locations
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            
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 Children's Memorial Hospital
  More Information

No publications provided

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

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

Study placed in the following topic categories:
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Anemia
Anemia, Hemolytic
Pain
Hemoglobinopathy
Thalassemia

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

ClinicalTrials.gov processed this record on September 02, 2009