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Clinical Trials/NCT06345638
NCT06345638
Completed
Not Applicable

Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease

University of Pennsylvania3 sites in 1 country52 target enrollmentMarch 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sickle Cell Disease
Sponsor
University of Pennsylvania
Enrollment
52
Locations
3
Primary Endpoint
C-reactive protein level
Status
Completed
Last Updated
9 months ago

Overview

Brief 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.
Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
June 17, 2025
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

C-reactive protein level

Time Frame: 1 month

Serum level of hs-CRP

Study Sites (3)

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