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

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00300235
First received: March 7, 2006
Last updated: June 15, 2009
Last verified: June 2009
History of Changes
Results First Received: March 13, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Conditions: Priapism
Anemia, Sickle Cell

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Age 5-9.9 HbSS/HbSβ0 Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
Age 10-14.9 HbSS/HbSβ0 Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
Age 15-24.9 HbSS/HbSβ0 Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
Age >25 HbSS/HbSβ0 Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
Age >15 HbSC/HbSβ+ Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+

Participant Flow:   Overall Study
    Age 5-9.9 HbSS/HbSβ0     Age 10-14.9 HbSS/HbSβ0     Age 15-24.9 HbSS/HbSβ0     Age >25 HbSS/HbSβ0     Age >15 HbSC/HbSβ+  
STARTED     208     240     398     362     251  
COMPLETED     208     240     398     362     251  
NOT COMPLETED     0     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Age 5-9.9 HbSS/HbSβ0 Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
Age 10-14.9 HbSS/HbSβ0 Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
Age 15-24.9 HbSS/HbSβ0 Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
Age >25 HbSS/HbSβ0 Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
Age >15 HbSC/HbSβ+ Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
Total Total of all reporting groups

Baseline Measures
    Age 5-9.9 HbSS/HbSβ0     Age 10-14.9 HbSS/HbSβ0     Age 15-24.9 HbSS/HbSβ0     Age >25 HbSS/HbSβ0     Age >15 HbSC/HbSβ+     Total  
Number of Participants  
[units: participants]
 		  208     240     398     362     251     1459  
Age  
[units: participants]
 		           
<=18 years     208     240     203     0     84     735  
Between 18 and 65 years     0     0     195     361     165     721  
>=65 years     0     0     0     1     2     3  
Age  
[units: years]
Mean ± Standard Deviation 		  7.4  ± 1.44     12.6  ± 1.46     19.3  ± 2.72     36.0  ± 8.93     29.8  ± 13.69     22.5  ± 12.65  
Gender  
[units: participants]
 		           
Female     0     0     0     0     0     0  
Male     208     240     398     362     251     1459  
Region of Enrollment  
[units: participants]
 		           
United States     208     240     398     362     251     1459  



  Outcome Measures

1.  Primary:   Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia.   [ Time Frame: At time of interview ]
  Show Outcome Measure 1

2.  Secondary:   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   [ Time Frame: Cross-sectional single survey visit ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Descriptive Comparison of the Prevalence of Priapism in Males With Sickle Cell Anemia to That Described in Older Patients With Other Sickle Hemoglobinopathies   [ Time Frame: Cross-sectional single survey visit ]
Results not yet posted.   Anticipated Posting Date:   06/2009   Safety Issue:   No

4.  Secondary:   Assessment of General Patient and Parent Understanding of Priapism as a Complication of Sickle Cell Disease Gained From Completion of Protocol   [ Time Frame: Cross-sectional single survey visit ]
Results not yet posted.   Anticipated Posting Date:   06/2009   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Karen Kesler, PhD
Organization: Rho Federal Systems Division
phone: 919-408-8000 ext 244
e-mail: karen_kesler@rhoworld.com


No publications provided


Responsible Party: Zora R. Rogers, MD, The University of Texas Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00300235     History of Changes
Other Study ID Numbers: 1319, U54 HL070587
Study First Received: March 7, 2006
Results First Received: March 13, 2009
Last Updated: June 15, 2009
Health Authority: United States: Federal Government