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OpenTrials
Completed

NCT Number: NCT06345638

Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. C-reactive protein level

    Time frame: 1 month

    Serum level of hs-CRP

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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