Sickle Cell DiseaseDrePlaquetteNCT06986837
Role of Inflammasome in Platelet Activation in Sickle Cell Disease Patient
An observational study of Sickle Cell Disease, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 92 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 14 Oct 2020to 20 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with sicke cell disease in a steady state at inclusion
Who may be able to join
- patients with SS or SC Sickle cell disease
- diagnosis of SCD performed by electrophoresis or HPLC in a reference laboratory for hemoglobinopathies
- clinically in a steady state at inclusion (without complication in the last month and without transfusion in the three last months)
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
During inflammation, platelets are activated through different cell signaling pathways, all of them leading to P selectin expression. Platelets activated by intravascular hemolysis (hemoglobin and heme) and High-Mobility Group Box protein 1 released by activated cells, participate to vaso-occlusive crisis occurrence through an increase of pro-inflammatory state. Toll-Like Receptor 4, expressed at the membrane of platelets, and the Nucleotide-binding domain Leucine Rich repeat containing Protein 3. inflammasome expressed by platelets, may also be involved in these processes. In addition, platelets express Bruton Tyrosine Kinase which could be activated through Nucleotide-binding domain Leucine Rich repeat containing Protein 3 and Toll-Like Receptor 4 pathways. These platelet cell signaling activation pathways related to inflammation, not well explored in Sickle cell disease, could connect platelet activation, inflammation and vaso-occlusive crisis . In this study, the collaborators will determine Nucleotide-binding domain Leucine Rich repeat containing Protein 3 activation state in platelets of Sickle cell disease patients.
Sickle cell disease patients will be recruited in the active file of the sickle cell center of Guadeloupe. Two groups of patients will be constituted: SS patients and SC patients. The control group will be patients who came for screening at the sickle cell center of Guadeloupe (University hospital of Guadeloupe, Pointe à Pitre).
Only one blood collection will be realized during the annual follow up visit of the patients and during the screening visit for the controls.
- Conditions
- Sickle Cell Disease
- Keywords
- platelets, NLRP3, HMGB1, BTK
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients SS | Sixty SS patients | |
| Patients SC | Twenty SC patients | |
| Control group AA | Patients without hemoglobin disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelets' Nucleotide-binding domain Leucine Rich repeat containing Protein 3 activation
flow cytometry
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start14 Oct 2020
- Primary completion5 Feb 2023
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- veronique Baccini, MD PhD, Principal investigator, CHU de la Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986837
- Sponsor's protocol ID
- PAP_RNI_2019/08
- Other IDs
- 2019-A03033-54
- Acronym
- DrePlaquette
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36464247
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Inflammasome in Platelet Activation in Sickle Cell Disease Patient
- ClinicalTrials.gov ID
- NCT06986837
- Acronym / sponsor ID
- DrePlaquette / PAP_RNI_2019/08
- Conditions
- Sickle Cell Disease
- Keywords
- platelets, NLRP3, HMGB1, BTK
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 5 Feb 2023 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 23 May 2025 (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 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.
Detailed description
During inflammation, platelets are activated through different cell signaling pathways, all of them leading to P selectin expression. Platelets activated by intravascular hemolysis (hemoglobin and heme) and High-Mobility Group Box protein 1 released by activated cells, participate to vaso-occlusive crisis occurrence through an increase of pro-inflammatory state. Toll-Like Receptor 4, expressed at the membrane of platelets, and the Nucleotide-binding domain Leucine Rich repeat containing Protein 3. inflammasome expressed by platelets, may also be involved in these processes. In addition, platelets express Bruton Tyrosine Kinase which could be activated through Nucleotide-binding domain Leucine Rich repeat containing Protein 3 and Toll-Like Receptor 4 pathways. These platelet cell signaling activation pathways related to inflammation, not well explored in Sickle cell disease, could connect platelet activation, inflammation and vaso-occlusive crisis . In this study, the collaborators will determine Nucleotide-binding domain Leucine Rich repeat containing Protein 3 activation state in platelets of Sickle cell disease patients.
Sickle cell disease patients will be recruited in the active file of the sickle cell center of Guadeloupe. Two groups of patients will be constituted: SS patients and SC patients. The control group will be patients who came for screening at the sickle cell center of Guadeloupe (University hospital of Guadeloupe, Pointe à Pitre).
Only one blood collection will be realized during the annual follow up visit of the patients and during the screening visit for the controls.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients SS | – | –Sixty SS patients |
| Patients SC | – | –Twenty SC patients |
| Control group AA | – | –Patients without hemoglobin disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with sicke cell disease in a steady state at inclusion
Key inclusion criteria (6 listed)
- patients with SS or SC Sickle cell disease
- diagnosis of SCD performed by electrophoresis or HPLC in a reference laboratory for hemoglobinopathies
- clinically in a steady state at inclusion (without complication in the last month and without transfusion in the three last months)
- 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
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
platelets' Nucleotide-binding domain Leucine Rich repeat containing Protein 3 activation
Time frame: Baseline
flow cytometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Results publication: PubMed 36464247Koehl 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.
- 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.
veronique Baccini, MD PhD principal investigator
CHU de la Guadeloupe
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 Sickle Cell Disease, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 23 May 2025. 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 Guadeloupe. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
platelets' Nucleotide-binding domain Leucine Rich repeat containing Protein 3 activation (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06986837, which also lists 1 linked publication.
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 23 May 2025.