Status:
COMPLETED
Genetics and Pain Severity in Sickle Cell Disease
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Genotype
Pain
Eligibility:
All Genders
18-99 years
Brief Summary
Background: \- Pain is the most common symptom of sickle cell disease. Episodes of severe sickle cell pain are known as "crises." High rates of pain crises are associated with a higher risk of early ...
Detailed Description
Sickle cell disease (SCD) is the most common genetic disease in the United States inherited as an autosomal recessive disorder, where approximately 70,000 individuals have sickle cell disease. Acute p...
Eligibility Criteria
Inclusion
- ELIGIBILITY CRITERIA FOR ALL PARTICIPANTS:
- All study participants must be of self-described African or African American ancestry. They will be at least 18 years old and must be able to provide informed, written consent for participation.
- INCLUSION CRITERIA:
- Inclusion Criteria for Sickle Cell Patients
- Diagnosis of sickle cell disease (documentation of SS, SC, S beta + thalassemia, S beta + thalassemia by electrophoresis is required).
- If taking chronic analgesics (NSAID, acetaminophen) or opioids, study subjects should be on a stable dose for 4 weeks prior to recruitment.
- Inclusion Criteria for Control Subjects
- Hemoglobin AA genotype by HPLC or hemoglobin electrophoresis.
- General good health defined as the absence of untreated major medical conditions (e.g. uncontrolled systemic hypertension, etc.).
- EXCLUSION CRITERIA:
- Exclusion Criteria for Sickle Cell Patients
- History of severe vaso-occlusive pain crisis resulting in either evaluation in an emergency department or admission to a hospital during the two weeks prior to study enrollment.
- Acute pain at the time of enrollment defined as spontaneous recent onset pain with a self rated score of 6 or higher on a scale of 0-10. (This is acute pain not the pain that subjects function at on a daily basis.)
- Exclusion Criteria for Control Subjects
- Acute pain or injury at enrollment or a recent history of chronic pain (daily pain reported for at least 6 months) in the past 3 years.
- Major medical/psychiatric illness known to cause pain.
- Sickle cell trait.
Exclusion
Key Trial Info
Start Date :
June 17 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 9 2020
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01441141
Start Date
June 17 2012
End Date
December 9 2020
Last Update
December 10 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892