NCT06986837

Brief Summary

Sickle cell disease is characterized by chronic hemolytic anemia, painful crisis called vaso-occlusive crisis and chronic inflammation. Activated platelets of Sickle cell disease patients participated to both chronic inflammation and painful vaso-occlusive crisis . The main aim of this study is to characterize the contribution of Nucleotide-binding domain Leucine Rich repeat containing Protein 3 inflammasome in platelets' activation in Sickle cell disease and to connect platelet activation, inflammation and sickle cell disease complication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 6, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

2.3 years

First QC Date

May 6, 2025

Last Update Submit

May 22, 2025

Conditions

Keywords

plateletsNLRP3HMGB1BTK

Outcome Measures

Primary Outcomes (1)

  • platelets' Nucleotide-binding domain Leucine Rich repeat containing Protein 3 activation

    flow cytometry

    Baseline

Study Arms (3)

Patients SS

Sixty SS patients

Patients SC

Twenty SC patients

Control group AA

Patients without hemoglobin disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with sicke cell disease in a steady state at inclusion

You may qualify if:

  • patients with SS or SC Sickle cell disease
  • diagnosis of SCD performed by electrophoresis or HPLC in a reference laboratory for hemoglobinopathies
  • patient followed up for Sickle cell disease at the sickle cell center of Guadeloupe (University hospital of Guadeloupe, Pointe à Pitre)
  • patients who will provide written informed consent in accordance with the Declaration of Helsinki
  • patients affiliated to national social security

You may not qualify if:

  • \- patients with hemoglobinopathy other than SS and SC Sickle cell disease
  • patients with a transfusion therapy or on bleeding therapy for less than three months
  • patients no affiliated to national social security
  • pregnant or breastfeeding patients
  • patients who will not provide written informed consent in accordance with the Declaration of Helsinki

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de La Guadeloupe

Pointe-à-Pitre, 97159, Guadeloupe

Location

Related Publications (1)

  • Koehl B, Claude L, Reminy K, Tarer V, Baccini V, Romana M, Colin-Aronovicz Y, Damaraju VL, Sawyer M, Peyrard T, Etienne-Julan M, Le Van Kim C, Azouzi S, Reininger L. Erythrocyte type 1 equilibrative nucleoside transporter expression in sickle cell disease and sickle cell trait. Br J Haematol. 2023 Mar;200(6):812-820. doi: 10.1111/bjh.18586. Epub 2022 Dec 4.

    PMID: 36464247BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

one blood collection will be realized during the annual follow up visit of the patients and during the screening visit for the controls

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

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

Study Officials

  • veronique Baccini, MD PhD

    CHU de la Guadeloupe

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 23, 2025

Study Start

October 14, 2020

Primary Completion

February 5, 2023

Study Completion

April 20, 2024

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations