Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease

March 26, 2024 updated by: University of Pennsylvania

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Females with SCD
Males with SCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein level
Time Frame: 1 month
Serum level of hs-CRP
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 854343

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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