Priapism in Boys and Men With Sickle Cell Disease - Demographics, Characteristics and Prevalence

NCT00300235 | Completed Results DMC

• 2 other identifiers: 1319U54HL070587
• Study Type: observational
• Target: 1,464
• Locations: 1 country
• Sites: 27

Brief Summary

Priapism, a prolonged erection of the penis, is a medical issue that often affects men with sickle cell disease. The purpose of this study is to collect demographic and clinical information on priapism by interviewing men with sickle cell disease.

Conditions

Priapism; Anemia, Sickle Cell

Keywords

Sickle Cell Anemia

Outcome Measures

Primary Outcomes (1)

• Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia.

  Subject responded YES to survey Question "Have you ever had priapism?". By diagnosis and age group. Enumeration of the prevalence of priapism in males with sickle cell anemia and sickle beta zero thalassemia.

  At time of interview

Secondary Outcomes (3)

• Characterization of Priapism in Males With Sickle Cell Anemia With Reference to Time of Onset, Duration of Events, Frequency of Episodes, Precipitating or Associated Activities, Treatment Modalities Used, and Outcome of Treatments

  Cross-sectional single survey visit

• Descriptive Comparison of the Prevalence of Priapism in Males With Sickle Cell Anemia to That Described in Older Patients With Other Sickle Hemoglobinopathies

  Cross-sectional single survey visit

• Assessment of General Patient and Parent Understanding of Priapism as a Complication of Sickle Cell Disease Gained From Completion of Protocol

  Cross-sectional single survey visit

Study Arms (5)

1

200 subjects ages 5 to 9.9 years with a diagnosis of HbSS/HbSβ0

2

400 subjects ages 10 to 14.9 years with a diagnosis of HbSS/HbSβ0

3

400 subjects ages 15 to 24.9 years with a diagnosis of HbSS/HbSβ0

4

400 subjects over the age of 25 with a diagnosis of HbSS/HbSβ0

5

250 subjects age 15 and older with a diagnosis of HbSC or HbSβ+

Eligibility Criteria

• Age: 5 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males receiving care in any Comprehensive Sickle Cell Center.

You may qualify if:

• Diagnosis of sickle cell anemia or sickle beta zero thalassemia, if 5 years of age or over OR
• Diagnosis of sickle beta plus thalassemia or sickle hemoglobin C disease, if 15 years of age or over
• Participant and/or parent or guardian must be able to communicate adequately with the interviewer

You may not qualify if:

• Subjects who meet any of the following criteria are disqualified from enrollment in the study:
• Patient or parent/guardian declines participation.
• Female.
• Subject or parent/guardian unable to communicate adequately with the interviewer.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (27)

University of South Alabama

Mobile, Alabama, 36688-0002, United States

Location

University of California, Davis

Davis, California, 95616, United States

Location

Children's Hospital and Research Center at Oakland & Summit Medical Center

Oakland, California, 94609, United States

Location

Kaiser Permanente, Oakland

Oakland, California, 94611, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80206, United States

Location

University of Florida

Gainesville, Florida, 32610-0383, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Brigham and Women's Hospital at Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of Boston

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

Children's Hospital Montefiore

The Bronx, New York, 10467-2940, United States

Location

Montefiore Medical Center and Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

University of Cincinnati Hospital

Cincinnati, Ohio, 45267, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

Location

St. Jude Children's Hospital

Memphis, Tennessee, 38105, United States

Location

University of Texas Parkland Health & Hospital System

Dallas, Texas, 75390-8852, United States

Location

University of Texas Children's Medical Center of Dallas

Dallas, Texas, 75390, United States

Location

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Priapism; Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; 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: Karen Kesler, PhD
• Organization: Rho Federal Systems Division

karen_kesler@rhoworld.com

919-408-8000

Study Officials

• Samir Ballas, MD

  Thomas Jefferson University

  STUDY CHAIR

• Lennette Benjamin

  Montefiore Medical Center and Children's Hospital of Montefiore

  STUDY CHAIR

• J. Bessman, MD

  University of Texas Southwestern at Galveston

  STUDY CHAIR

• Joan Cain, MD

  UT Children's Hospital of Oklahoma

  STUDY CHAIR

• Lewis Hsu, MD

  St. Christopher's Hospital

  STUDY CHAIR

• Laura DeCastro, MD

  Duke University

  STUDY CHAIR

• Cage Johnson, MD

  University of Southern California Los Angeles County & University of Southern California Medical Center

  STUDY CHAIR

• Karen Kalinyak, MD

  Children's Hospital Medical Center, Cincinnati

  STUDY CHAIR

• Susan Lieff, PhD

  Rho, Inc.

  STUDY CHAIR

• Lillian McMahon, MD

  Boston Medical Center

  STUDY CHAIR

• William Mentzer, MD

  University of California San Francisco Pediatric Hematology/Oncology

  STUDY CHAIR

• Ashok Raj, MD

  Norton Healthcare

  STUDY CHAIR

• Rupa Redding-Lallinger, MD

  University of North Carolina, Chapel Hill

  STUDY CHAIR

• Zora R. Rogers, MD

  University of Texas Southwestern Medical Center at Dallas and Children's Medical Center

  STUDY CHAIR

• Cynthia Rutherford, MD

  University of Texas, Southwestern Medical Center at Dallas

  STUDY CHAIR

• Kim Smith-Whitley, MD

  Children's Hospital of Philadelphia

  STUDY CHAIR

• Elliott Vichinsky, MD

  Children's Hospital and Research Center at Oakland & Summit Medical Center

  STUDY CHAIR

• Winfred Wang, MD

  St. Jude Children's Research Hospital

  STUDY CHAIR

• Richard Snyder, MD

  University of Cincinnati

  STUDY CHAIR

• Kathryn Hassell, MD

  University of Colorado, Denver

  STUDY CHAIR

• Matthew Heeney, MD

  Boston Children's Hospital

  STUDY CHAIR

• Eric Kraut, MD

  Ohio State University

  STUDY CHAIR

• Stacy Month, MD

  Kaiser Permanente - Oakland

  STUDY CHAIR

• Maureen Okam, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

• Courtney Thornburg, MD

  Duke University

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: March 8, 2006
• Study Start: August 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 1, 2019
• Results First Posted: August 3, 2009

Record last verified: 2019-01

Locations

US (27)