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Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease

Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06345638
Enrollment
52
Registered
2024-04-03
Start date
2024-03-01
Completion date
2025-06-17
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease, Vaso-occlusive Crisis

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.

Interventions

None listed

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
C-reactive protein level1 monthSerum level of hs-CRP

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026