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Active, not recruitingNCT05646888Il-PadreUpdated Mar 19, 2026

Inflammation, Platelets and Sickle Cell Disease

An observational study in Platelet Activation, Thromboinflammation and Sickle Cell Disease, sponsored by University Hospital, Toulouse. Active, not recruiting at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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.

Read the detailed description

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
02

Conditions studied

  • Platelet Activation
  • Thromboinflammation
  • Sickle Cell Disease

Keywords

  • Sickle cell disease
  • vaso-occlusive crisis
  • platelets
  • thrombo-inflammation
03

In context

Anemia, Sickle Cell

1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.

This study's planned enrollment of 25 is below the median of 100 across 287 observational studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with sickle cell disease diagnosis

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No

Interventions

  • BiologicalBlood sampling

    the blood sample will be taken during a planned blood sampling

06

What researchers measure

Primary outcomes

  1. To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.

    by flow cytometry analysis

    Time frame: First 48h of hospitalization

  2. To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.

    by flow cytometry analysis

    Time frame: Day 13 (+/- 2 days)

  3. To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.

    by flow cytometry analysis

    Time frame: At day 60 (+/- 2 days)

07

Study locations

1 site
  • IUCT-Oncopole University Hospital
    Toulouse, 31500, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05646888
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Dec 12, 2022
Start date
Jan 15, 2023
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Mar 19, 2026

Study contacts

Pierre Cougoul, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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