Sickle Cell DiseaseSTIREXNCT06769139
Evaluation of the Impact of Red Blood Cell Exchange on Thrombo-inflammation in Sickle Cell Disease
An observational study of Sickle Cell Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Sickle cell disease is the most common inherited blood disorder worldwide. It is a hemoglobinopathy characterized by chronic hemolysis, endotheliopathy, coagulation activation, and chronic inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Red blood cell exchange
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2025to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be identified during a follow-up consultation in the internal medicine department.
Who may be able to join
- Sickled Cell Disease patient with SS or S/beta thalassemia genotype
- Red blood cell exchange > 3 months
- Up-to-date social security coverage
- Patient able to understand the purpose and constraints of the research project
- Patient has read the study information leaflet and does not object to the research.
Who cannot join
- Thrombopenia < 50 G/L
- Non-steroidal anti-inflammatory drugs < 7 days before enrolment
- Anti-platelet agents < 7 days before enrolment
- Pregnancy or breastfeeding
- Patient objects to take part in the study
- Patient under guardianship, curatorship or safeguard of justice
- Patients with ongoing clinical trial requiring collection of additional blood samples
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Oncopole - Toulouse Hospital
Toulouse, 31059
Pierre COUGOUL, MD, 0531156265 ext. +33, cougoul.pierre@iuct-oncopole.fr
Pierre COUGOUL, MD
About this study
Official title: Evaluation of the Impact of Red Blood Cell Exchange on Thrombo-inflammation in Sickle Cell Disease STIREX : Sickle Cell Disease - Thrombo-Inflammation - Red Blood Cell EXchange
Sickle cell disease is the most common inherited blood disorder worldwide. It is a hemoglobinopathy characterized by chronic hemolysis, endotheliopathy, coagulation activation, and chronic inflammation. It is a multisystemic disease leading to acute (vaso-occlusive crisis, acute chest syndrome, stroke…) and chronic complications with multiorgan damage. Thrombo-inflammation is defined by the cooperation and interaction between hemostasis and the innate immune system. The platelet represents the cornerstone of this phenomenon, being at the interface of these two systems. In sickle cell disease, platelets are activated and release cytokines, leading to a pro-coagulant and pro-inflammatory state. Transfusion, whether occasional or chronic, is a major sickle cell disease treatment. It is common to distinguish simple transfusion from exchange transfusion. The latter involves replacing a given volume of sickle red blood cells with healthy red blood cells. Exchange transfusion allows avoiding an excessive increase in hemoglobin. The decrease of hemoglobin S under 30% achieved by red blood cell exchange reduces the risk of stroke by more than 90% in children with cerebral vasculopathy. Moreover, transfusion can be used in acute complications such as vaso-occlusive crisis and acute chest syndrome. Despite this efficacy, a subgroup of patients is not totally protected against acute and chronic complications. The persistence of chronic inflammation is suggested. To date, it is not known if red blood cell exchange can reduce the thrombo-inflammatory dynamic in sickle cell disease. The aim of this study is to evaluate the impact of red blood cell exchange on thrombo-inflammatory parameters in 20 adult sickle cell patients (10 patients on manual exchange and 10 patients on automatized exchange).
Read the detailed description
Prospective observational cohort with additional blood samples. This study is monocentric.
- Conditions
- Sickle Cell Disease
- Being tested
- Red blood cell exchange
- Keywords
- thrombo-inflammation, Red blood cell Exchange
- 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.
Red blood cell exchangeOther
Red blood cell exchange manual exchange and automatized exchange
| Study group | Role | What they receive |
|---|---|---|
| Sickle patients treated by red blood cell exchange | 20 adult sickle cell patients treated by red blood cell exchange (10 patients on manual exchange and 10 patients on automatized exchange) Receives: Other: Red blood cell exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of thrombo-inflammation parameters in sickle patients treated by red blood cell exchange
Thrombo-inflammation is evaluate using a composite criteria composed by 4 thromo-inflammatory parameters : soluble platelet activation markers, inflammasome, platelet response, circulating platelet microparticles and lipidomic study of plasma eicosanoids.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Etablissement Français du Sang
- Responsible party
- Sponsor
- Investigators
- Pierre COUGOUL, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769139
- Sponsor's protocol ID
- RC31/24/0509
- Acronym
- STIREX
- Status last verified
- Jan 2025
- First submitted
- 18 Nov 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Red Blood Cell Exchange on Thrombo-inflammation in Sickle Cell Disease STIREX : Sickle Cell Disease - Thrombo-Inflammation - Red Blood Cell EXchange
- ClinicalTrials.gov ID
- NCT06769139
- Acronym / sponsor ID
- STIREX / RC31/24/0509
- Conditions
- Sickle Cell Disease
- Keywords
- thrombo-inflammation, Red blood cell Exchange
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Etablissement Français du Sang
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 10 Jan 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 the most common inherited blood disorder worldwide. It is a hemoglobinopathy characterized by chronic hemolysis, endotheliopathy, coagulation activation, and chronic inflammation. It is a multisystemic disease leading to acute (vaso-occlusive crisis, acute chest syndrome, stroke…) and chronic complications with multiorgan damage. Thrombo-inflammation is defined by the cooperation and interaction between hemostasis and the innate immune system. The platelet represents the cornerstone of this phenomenon, being at the interface of these two systems. In sickle cell disease, platelets are activated and release cytokines, leading to a pro-coagulant and pro-inflammatory state. Transfusion, whether occasional or chronic, is a major sickle cell disease treatment. It is common to distinguish simple transfusion from exchange transfusion. The latter involves replacing a given volume of sickle red blood cells with healthy red blood cells. Exchange transfusion allows avoiding an excessive increase in hemoglobin. The decrease of hemoglobin S under 30% achieved by red blood cell exchange reduces the risk of stroke by more than 90% in children with cerebral vasculopathy. Moreover, transfusion can be used in acute complications such as vaso-occlusive crisis and acute chest syndrome. Despite this efficacy, a subgroup of patients is not totally protected against acute and chronic complications. The persistence of chronic inflammation is suggested. To date, it is not known if red blood cell exchange can reduce the thrombo-inflammatory dynamic in sickle cell disease. The aim of this study is to evaluate the impact of red blood cell exchange on thrombo-inflammatory parameters in 20 adult sickle cell patients (10 patients on manual exchange and 10 patients on automatized exchange).
Detailed description
Prospective observational cohort with additional blood samples. This study is monocentric.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sickle patients treated by red blood cell exchange | – | Other: Red blood cell exchange20 adult sickle cell patients treated by red blood cell exchange (10 patients on manual exchange and 10 patients on automatized exchange) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be identified during a follow-up consultation in the internal medicine department.
Key inclusion criteria (5 listed)
- Sickled Cell Disease patient with SS or S/beta thalassemia genotype
- Red blood cell exchange > 3 months
- Up-to-date social security coverage
- Patient able to understand the purpose and constraints of the research project
- Patient has read the study information leaflet and does not object to the research.
Key exclusion criteria (7 listed)
- Thrombopenia < 50 G/L
- Non-steroidal anti-inflammatory drugs < 7 days before enrolment
- Anti-platelet agents < 7 days before enrolment
- Pregnancy or breastfeeding
- Patient objects to take part in the study
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 |
|---|---|---|
| Red blood cell exchangeRed blood cell exchange manual exchange and automatized exchange | Other | Sickle patients treated by red blood cell exchange |
Primary outcome
Evaluation of thrombo-inflammation parameters in sickle patients treated by red blood cell exchange
Time frame: 2 days
Thrombo-inflammation is evaluate using a composite criteria composed by 4 thromo-inflammatory parameters : soluble platelet activation markers, inflammasome, platelet response, circulating platelet microparticles and lipidomic study of plasma eicosanoids.
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 10 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Sickle Cell Disease, 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 7 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: opening soon, as of the sponsor's last update on 10 Jan 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 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?
Contact Pierre COUGOUL, MD (0531156265 ext. +33, cougoul.pierre@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of thrombo-inflammation parameters in sickle patients treated by red blood cell exchange (time frame: 2 days). 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 10 Jan 2025.