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Inflammation, Platelets and Sickle Cell Disease

NCT ID: NCT05646888

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-15

Study Completion Date

2025-12-30

Brief Summary

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Sickle cell disease (SCD) is an autosomal recessive genetic disorder linked to a single mutation on beta-globin chains. This leads to red blood cell deformation and chronic hemolysis which can result in vaso-occlusive events, anemia and vasculopathy. Pathophysiology is incompletely understood, and beyond red blood cell's abnormalities this involves hemostasis and innate immunity. The aim of our study is to describe the mechanisms of thrombo-inflammation during the vaso-occlusive crisis (VOC) in adults with sickle cell disease.

Detailed Description

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Pathophysiology of sickle cell disease is incompletely understood. The typical change of red blood cells into sickle cells lead to post-capillary stream abnormalities. This phenomenon is responsible of ischemia-reperfusion injuries. Chronic hemolysis is the second part of the pathophysiology. The consequences are vasoconstriction, endothelial lesions, chronic inflammation, hemostasis and platelets activation. Thrombo-inflammation concept was proposed by Tanguay to describe the interactions between hemostasis, platelets and innate immune cells (neutrophils polynuclear) during thrombotic process. Since this time, this concept was largely described in many clinical situations such as septicemia, COVID-19, coronaropathy, auto-immune diseases and sickle cell disease.

In this project, we will study platelets activation and thrombo-inflammation markers in the beginning of a vaso-occlusive crisis, during the crisis and two months after the crisis. Blood samples will be collected during a routine care sample.

Biological markers studied will be:

* Soluble and surface markers of platelet activation; platelet-leukocytes aggregates
* Plasmatic eicosanoids produced by platelets (TXB2) and immune cells
* In vitro platelets reactivity; dynamic thrombus formation in normal and pathologic arterial blood stream
* Platelet's inflammasome

Conditions

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Platelet Activation Thromboinflammation Sickle Cell Disease

Keywords

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Sickle cell disease vaso-occlusive crisis platelets thrombo-inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood sampling

the blood sample will be taken during a planned blood sampling

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patient with sickle cell disease diagnosis, hospitalized in emergency department and/or internal medicine department
* Patient older than 18 years
* Written consent to participate to the study
* Patient with health insurance
* Patient able to receive information about the study

Exclusion Criteria

* Age \< 18 years
* Non consent to participate to the study
* Women in pregnancy or breastfeeding
* Treatment with aspirin or non steroidal anti inflammatory drug
* Protected patient
* Patient already involved in a study requiring collection of additional biological samples
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Cougoul, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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IUCT-Oncopole University Hospital

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre Cougoul, MD

Role: CONTACT

Phone: 531156265

Email: [email protected]

Sandra De Barros

Role: CONTACT

Email: [email protected]

Facility Contacts

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Pierre Cougoul, MD

Role: primary

Other Identifiers

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RC31/22/0255

Identifier Type: -

Identifier Source: org_study_id