Platelet ActivationIl-PadreNCT05646888
Inflammation, Platelets and Sickle Cell Disease
An observational study of Platelet Activation and Thromboinflammation, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Platelet Activation, Thromboinflammation, Sickle Cell Disease
- What is being tested?
- Blood sampling
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2023to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sickle cell disease diagnosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Blood sampling
- Keywords
- Sickle cell disease, vaso-occlusive crisis, platelets, thrombo-inflammation
- Medical subject headings
- Thromboinflammation, Anemia, Sickle Cell, Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
the blood sample will be taken during a planned blood sampling
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.
by flow cytometry analysis
Measured: First 48h of hospitalization
To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.
by flow cytometry analysis
Measured: Day 13 (+/- 2 days)
To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.
by flow cytometry analysis
Measured: At day 60 (+/- 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start15 Jan 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet ActivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Cougoul, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646888
- Sponsor's protocol ID
- RC31/22/0255
- Acronym
- Il-Padre
- Status last verified
- Mar 2026
- First submitted
- 6 Sep 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation, Platelets and Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT05646888
- Acronym / sponsor ID
- Il-Padre / RC31/22/0255
- Keywords
- Sickle cell disease, vaso-occlusive crisis, platelets, thrombo-inflammation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sickle cell disease diagnosis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingthe blood sample will be taken during a planned blood sampling | Biological | – |
Primary outcome
To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.
Time frame: First 48h of hospitalization
by flow cytometry analysis
To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.
Time frame: Day 13 (+/- 2 days)
by flow cytometry analysis
To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.
Time frame: At day 60 (+/- 2 days)
by flow cytometry analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Cougoul, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Activation and Thromboinflammation, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis. (time frame: First 48h of hospitalization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.