Sickle Cell Disease Clinical Trial
Official title:
Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease
| Verified date | March 2024 |
| Source | University of Pennsylvania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study aims to characterize sex differences in the pathophysiology of vaso-occlusive crises (VOC) occurring among individuals with sickle cell disease (SCD). - The study will compare CRP and other biomarkers between females with SCD in the follicular phase of the menstrual cycle and males with SCD. - The study will explore potential sex differences in biomarker changes between females and males with SCD during and following resolution of VOC. - The study will compare neutrophil and platelet adhesion to the endothelium and real time fibrin deposition in the blood.
| Status | Enrolling by invitation |
| Enrollment | 40 |
| Est. completion date | May 31, 2025 |
| Est. primary completion date | April 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility | Inclusion Criteria: - Adult males and females aged 18-45 - Diagnosis of sickle cell disease - current hospitalization for vaso-occlusive pain episode or current outpatient infusion at the recruiting sites - Able to read and understand English - Willing to comply with study procedures Exclusion Criteria: - Currently pregnant, pregnant within the last month, or seeking to become pregnant |
| Country | Name | City | State |
|---|---|---|---|
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Penn Medicine University City | Philadelphia | Pennsylvania |
| United States | Pennsylvania Hospital | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| University of Pennsylvania |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | C-reactive protein level | Serum level of hs-CRP | 1 month |
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