NCT06345638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2025

Completed
Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

March 12, 2024

Last Update Submit

July 31, 2025

Conditions

Sickle Cell DiseaseVaso-occlusive Crisis

Outcome Measures

Primary Outcomes (1)

  • C-reactive protein level

    Serum level of hs-CRP

    1 month

Study Arms (2)

Females with SCD

Males with SCD

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Penn Medicine University City

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19143, United States

Location

MeSH Terms

Conditions

Anemia, Sickle CellVaso-Occlusive Crises

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2024

First Posted

April 3, 2024

Study Start

March 1, 2024

Primary Completion

June 17, 2025

Study Completion

June 17, 2025

Last Updated

August 5, 2025

Record last verified: 2025-07

Locations

US(3)