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CompletedNCT06345638Updated Aug 5, 2025

Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease

An observational study in Sickle Cell Disease and Vaso-occlusive Crisis, sponsored by University of Pennsylvania. Completed at 3 sites in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-08-05.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
52
Ages
18 Years to 45 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Sickle Cell Disease
  • Vaso-occlusive Crisis
03

In context

Anemia, Sickle Cell

1,104 studies on the registry are indexed under Anemia, Sickle Cell; 236 are open to participants now.

This study's enrollment of 52 is below the median of 100 across 288 observational studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individual with sickle cell disease receiving care for vaso-occlusive pain episodes.

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

Exclusion Criteria:

  • Currently pregnant, pregnant within the last month, or seeking to become pregnant
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
52 participants (actual)
Patient registry
No

Groups and cohorts

  • Females with SCD
  • Males with SCD
06

What researchers measure

Primary outcomes

  1. C-reactive protein level

    Serum level of hs-CRP

    Time frame: 1 month

07

Study locations

3 sites
  • Penn Medicine University City
    Philadelphia, Pennsylvania 19104, United States
  • Pennsylvania Hospital
    Philadelphia, Pennsylvania 19107, United States
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19143, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06345638
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Apr 3, 2024
Start date
Mar 1, 2024
Primary completion
Jun 17, 2025
Completion
Jun 17, 2025
Last update
Aug 5, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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