NCT06887907

Brief Summary

Sickle cell disease is the most common inherited blood disorder in the world. Chronic hemolysis induces platelet activation and chronic inflammation. Platelets and megakaryocyte, as medullar platelets precursors, are known to play a role in innate immunity. Little is known about the role of megakaryocytes at basal state and during acute complication in sickle cell disease patients. The aim of this study is to evaluate the role of megakaryocytes in sickle cell disease.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
23mo left

Started Mar 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress38%
Mar 2025Apr 2028

Study Start

First participant enrolled

March 13, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

March 14, 2025

Last Update Submit

March 14, 2025

Conditions

Keywords

MegakaryocyteSickle Cell Disease

Outcome Measures

Primary Outcomes (1)

  • Description of circulant megakaryocytes

    Phenotypic and transcriptomic description of circulant megakaryocytes in sickle cell patient

    12 months

Study Arms (4)

Sickle cell disease patients at rest since at least 1 year

Patient at steady state since at least 1 year

Sickle cell disease patients at rest

Patient at steady state (without crises)

Vaso-occlusive crisis

Sickle cell disease patients during vaso-occlusive crisis

Acute chest syndrome

Sickle cell disease patients during acute chest syndrome

Eligibility Criteria

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

Patient from CHU de Toulouse at steady state since at least 1 year or at steady state (without crisis), or during vaso-occlusive crisis or during acute chest syndrome

You may qualify if:

  • Sickle cell disease SS or S-béta° thalassemia
  • Patient at steady state since at least 1 year or at steady state (without crisis), or during vaso-occlusive crisis or during acute chest syndrome
  • Age \> 18 years old

You may not qualify if:

  • Patient objects to take part in the study Hematologic disorder (leukemia, myeloma, myelodysplasic syndrome, myeloproliferative syndrome)
  • Immune thrombocytopenia, Immunosuppressive or anti-inflammatory (biotherapies, corticosteroids, non steroidal anti-inflammatories drugs) Page 12 sur 23
  • Anti-platelets agents
  • Red blood cell exchange or transfusion \< 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, France, 31059, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample withdraw from sickle cell disease patients

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

  • Pierre COUGOUL, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 14, 2025

First Posted

March 20, 2025

Study Start

March 13, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations