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NCT06345638 Clinical Trial

Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:
Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06345638
Other study ID # 854343
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date May 31, 2025

Study information
Verified date March 2024
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary C-reactive protein level Serum level of hs-CRP 1 month
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