CompletedNot Applicable

Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease

United States52 participantsStarted 2024-03-01

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

C-reactive protein level

Timeframe: 1 month

Trial details

NCT IDNCT06345638

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-17

View on ClinicalTrials.gov More Sickle Cell Disease trials