Assessment of Pain in People With Thalassemia

NCT00872339 | Completed Results DMC

• 2 other identifiers: 639U01HL065238
• Study Type: observational
• Target: 252
• Locations: 2 countries
• Sites: 8

Brief Summary

Thalassemia is an inherited blood disorder that can result in mild to severe anemia. People with thalassemia often experience pain, but the exact sources and prevalence of pain remain unknown. This study will examine the prevalence and severity of pain in people with thalassemia who are treated with regular blood transfusions and people with thalassemia who are not treated with regular blood transfusions.

Conditions

Thalassemia

Keywords

Transfusion-Dependent Thalassemia; Non-Transfusion-Dependent Thalassemia

Outcome Measures

Primary Outcomes (1)

• Prevalence of Pain

  Measured at Month 9

Secondary Outcomes (3)

• Common Sites of Pain

  Measured at Month 9

• Pain Occurrence by Age

  Measured at Month 9

• Impact of Pain on Functioning and Well-being

  Measured at Month 9

Study Arms (3)

transfusion-dependant

People with transfusion-dependant thalassemia who received at least 8 transfusions in the past year.

non-transfusion-dependant

People with non-transfusion-dependant thalassemia who received no transfusions in the past year.

intermittently transfused

Intermittently transfused patients- individuals who received at least one but fewer than eight transfusions in the last year

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thalassemia patients who receive regular blood transfusions and those who do not receive regular blood transfusions.

You may qualify if:

• Thalassemia, as documented by clinical diagnosis, including the following:
• B-thalassemia (intermedia or major)
• Hgb H disease
• Hgb H with non-deletional mutations (e.g., Hgb H Constant Spring)
• E-B-thalassemia
• Homozygous alpha thalassemia
• Other thalassemic conditions not explicitly excluded
• Thalassemia intermedia due to heterozygous B mutation with an alpha excess
• Participants can be of any race, ethnicity, and either gender.

You may not qualify if:

• Thalassemia trait (i.e., single recessive B gene mutation, 2 gene alpha mutation) and thalassemia Hgb S, C, or D compound heterozygotes
• Unwillingness or inability to complete the Brief Pain Inventory (BPI) on a quarterly basis
• Has had a successful bone marrow transplant

Sponsors & Collaborators

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

Study Sites (8)

Children's Hospital and Research Institute at Oakland

Oakland, California, 94609, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

Children's Memorial Hospital of Chicago

Chicago, Illinois, 60614, United States

Location

Children's Hospital of Boston

Boston, Massachusetts, 02115, United States

Location

Weill Medical College

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

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• Haines D, Martin M, Carson S, Oliveros O, Green S, Coates T, Eile J, Schilling L, Dinu B, Mendoza T, Gerstenberger E, Trachtenberg F, Vichinsky E; Thalassemia Clinical Research Network. Pain in thalassaemia: the effects of age on pain frequency and severity. Br J Haematol. 2013 Mar;160(5):680-7. doi: 10.1111/bjh.12177. Epub 2012 Dec 30.

  PMID: 23278768 RESULT

MeSH Terms

Conditions

Thalassemia

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

Results Point of Contact

• Title: Felicia Trachtenberg
• Organization: New England Research Institutes

ftrachtenberg@neriscience.com

6179723120

Study Officials

• Jeanne Boudreeaux, MD

  Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

• Ellis Neufeld, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Alexis Thompson, MD

  Children's Memorial Hospital of Chicago

  PRINCIPAL INVESTIGATOR

• Brigitta Mueller, MD

  Baylor College of Medicine at Houston

  PRINCIPAL INVESTIGATOR

• Dru Foote, RN, NP

  Children's Hospital and Research Institute of Oakland

  STUDY CHAIR

• Patricia Giardina, MD

  Weill Medical College of Cornell

  PRINCIPAL INVESTIGATOR

• Janet Kwiatkowski, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Nancy Olivieri, MD

  Toronto General Hospital

  PRINCIPAL INVESTIGATOR

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: March 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 5, 2014
• Results First Posted: June 5, 2014

Record last verified: 2014-01

Locations

US (7); CA (1)