DrepanocytosisFITREDNCT05850156
Study of a Deformability Parameter of Red Blood Cell
An observational study of Drepanocytosis, run by Assistance Publique Hopitaux De Marseille.
Trial summary
Sickle-cell disease is one of the most common severe monogenic disorders in the world, it results in the synthesis of abnormal hemoglobin (HbS) instead of hemoglobin A. When deoxygenated, the sickle haemoglobin (HbS) polymerizes inducing the sickling of red blood cells (RBCs) and leading to decreased deformability and… Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Drepanocytosis
- What is being tested?
- basal blood collection, blood collection M6 and blood collection M12
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Mar 2027
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and pediatric sickle cell patients, adult sickle cell carriers (heterozygous), and adult control subjects (homozygous).
Who may be able to join
- Repeatability of ftt (mechanical marker of deformability) measurements
Who cannot join
- Effect of ambient temperature on ftt measurements
- Effect of sample processing time on ftt measurements
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study of a Deformability Parameter of Red Blood Cell. FITRED
Sickle-cell disease is one of the most common severe monogenic disorders in the world, it results in the synthesis of abnormal hemoglobin (HbS) instead of hemoglobin A. When deoxygenated, the sickle haemoglobin (HbS) polymerizes inducing the sickling of red blood cells (RBCs) and leading to decreased deformability and increased fragility. Therefore, sickle RBCs exhibit a reduced lifespan associated with intravascular hemolysis, hemolytic anemia and low tissue oxygenation. Sickle RBCs, which exhibit abnormal adhesive properties to endothelial cells, can block the microcirculation, causing the occurrence of painful vaso-occlusive crisis (VOC), acute chest syndrome (ACS), acute and chronic organ damage (heart, lung, liver, spleen, kidney, bone…) and shortened life span.
A preliminary study performed on RBC from sickle cell patients (Hb SS) has shown an alteration of a parameter measuring the overall deformability of RBCs by evaluating the nature of their movement in a shear flow. This parameter is significantly lower in sickle cell patients in steady state compared to a population of healthy individuals. The parameter is also significantly lower in sickle cell patients during VOC when compared to patient in steady state.
The main objective of this study is to evaluate the performance of the method for measuring the deformability of RBCs on an experimental prototype. Measurements will be performed on blood samples from subjects with a normal hemoglobin electrophoretic profile, from heterozygous carriers of sickle cell disease and from patients with sickle cell disease. Samples from paediatric patients will also be tested to study any specificity in comparison to adult subjects.
- Conditions
- Drepanocytosis
- Being tested
- basal blood collection, blood collection M6, blood collection M12
- Medical subject headings
- Sickle Cell Trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
basal blood collectionProcedure or surgery
blood collection is performed in the context of routine care for hemoglobin analysis. An additional volume of 300µL of blood is taken for the purposes of the study
blood collection M6Procedure or surgery
6 months +/- 2 months after inclusion, a blood collection is performed in the context of routine care for hemoglobin analysis. An additional volume of 300µL of blood is taken for the purposes of the study
blood collection M12Procedure or surgery
12 months +/- 2 months after inclusion, a blood collection is performed in the context of routine care for hemoglobin analysis. An additional volume of 300µL of blood is taken for the purposes of the study
| Study group | Role | What they receive |
|---|---|---|
| Adult sickle cell patients | In the context of routine care, 3 blood collection will be performed on adult sickle cell patients for the analysis of hemoglobin fractions. For each blood collection, an additional volume of blood will be taken for the research purposes. Receives: Procedure: basal blood collection; Procedure: blood collection M6; Procedure: blood collection M12 | |
| pediatric sickle cell patients | In the context of routine care, 3 blood collection will be performed on pediatric sickle cell patients for the analysis of hemoglobin fractions. For each blood collection, an additional volume of blood will be taken for the research purposes. Receives: Procedure: basal blood collection; Procedure: blood collection M6; Procedure: blood collection M12 | |
| Adult sickle cell carriers (heterozygous patients) | In the context of neonatal screening for sickle cell disease, the parents will be called altogether with their children in order to check if they are sickle cell carriers or not. Only 1 blood collection will be performed for this group. Receives: Procedure: basal blood collection | |
| Control patients | In the context of neonatal screening for sickle cell disease, the parents will be called altogether with their children in order to check if they are sickle cell carriers or not. Only 1 blood collection will be performed for this group. Receives: Procedure: basal blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
repeatability of fTT measurements
A series of 10 measurements of a deformability of red blood cells parameter (fTT) on the same blood sample will be performed successively within 24 hours for 4 samples (2 from sickle cell patient and 2 from control or heterozygous patients). The repeatability of the measurements will be determined from these measurements and the effect of a variation in the total number of red blood cells will be analyzed.This study will be reproduced on several blood samples and the measurements will be repeated under the same conditions 24 hours later.
Measured: 14 months
Secondary outcomes (3)
Effect of ambient temperature during fTT measurement
Tests will be conducted to evaluate the effect of ambient temperature on the measurement of a series of 4 samples at ambient temperature (from 18 to 30°C).
Measured: 14 months
Effect of the processing time on fTT measurement
test will be conducted to measure the fTT on a series of 10 samples, twice a day during the 2 first days an then every day for 5 days.
Measured: 14 months
Correlation of ftt with the collected data
A correlation study of ftt with socio-demographic (age and sex), biological (results of hemogram and hemoglobin electrophoresis) and clinical (number of vaso-occlusive crises and treatment with Hydroxyurea) will be conducted.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DrepanocytosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850156
- Sponsor's protocol ID
- RCAPHM22_0433
- Acronym
- FITRED
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Deformability Parameter of Red Blood Cell. FITRED
- ClinicalTrials.gov ID
- NCT05850156
- Acronym / sponsor ID
- FITRED / RCAPHM22_0433
- Conditions
- Drepanocytosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 May 2023 (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 one of the most common severe monogenic disorders in the world, it results in the synthesis of abnormal hemoglobin (HbS) instead of hemoglobin A. When deoxygenated, the sickle haemoglobin (HbS) polymerizes inducing the sickling of red blood cells (RBCs) and leading to decreased deformability and increased fragility. Therefore, sickle RBCs exhibit a reduced lifespan associated with intravascular hemolysis, hemolytic anemia and low tissue oxygenation. Sickle RBCs, which exhibit abnormal adhesive properties to endothelial cells, can block the microcirculation, causing the occurrence of painful vaso-occlusive crisis (VOC), acute chest syndrome (ACS), acute and chronic organ damage (heart, lung, liver, spleen, kidney, bone…) and shortened life span.
A preliminary study performed on RBC from sickle cell patients (Hb SS) has shown an alteration of a parameter measuring the overall deformability of RBCs by evaluating the nature of their movement in a shear flow. This parameter is significantly lower in sickle cell patients in steady state compared to a population of healthy individuals. The parameter is also significantly lower in sickle cell patients during VOC when compared to patient in steady state.
The main objective of this study is to evaluate the performance of the method for measuring the deformability of RBCs on an experimental prototype. Measurements will be performed on blood samples from subjects with a normal hemoglobin electrophoretic profile, from heterozygous carriers of sickle cell disease and from patients with sickle cell disease. Samples from paediatric patients will also be tested to study any specificity in comparison to adult subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult sickle cell patients | – | Procedure: basal blood collection, Procedure: blood collection M6, Procedure: blood collection M12In the context of routine care, 3 blood collection will be performed on adult sickle cell patients for the analysis of hemoglobin fractions. For each blood collection, an additional volume of blood will be taken for the research purposes. |
| pediatric sickle cell patients | – | Procedure: basal blood collection, Procedure: blood collection M6, Procedure: blood collection M12In the context of routine care, 3 blood collection will be performed on pediatric sickle cell patients for the analysis of hemoglobin fractions. For each blood collection, an additional volume of blood will be taken for the research purposes. |
| Adult sickle cell carriers (heterozygous patients) | – | Procedure: basal blood collectionIn the context of neonatal screening for sickle cell disease, the parents will be called altogether with their children in order to check if they are sickle cell carriers or not. Only 1 blood collection will be performed for this group. |
| Control patients | – | Procedure: basal blood collectionIn the context of neonatal screening for sickle cell disease, the parents will be called altogether with their children in order to check if they are sickle cell carriers or not. Only 1 blood collection will be performed for this group. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric sickle cell patients, adult sickle cell carriers (heterozygous), and adult control subjects (homozygous).
Key inclusion criteria (1 listed)
- Repeatability of ftt (mechanical marker of deformability) measurements
Key exclusion criteria (2 listed)
- Effect of ambient temperature on ftt measurements
- Effect of sample processing time on ftt measurements
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 |
|---|---|---|
| basal blood collectionblood collection is performed in the context of routine care for hemoglobin analysis. An additional volume of 300µL of blood is taken for the purposes of the study | Procedure or surgery | Adult sickle cell carriers (heterozygous patients), Adult sickle cell patients, Control patients, pediatric sickle cell patients |
| blood collection M66 months +/- 2 months after inclusion, a blood collection is performed in the context of routine care for hemoglobin analysis. An additional volume of 300µL of blood is taken for the purposes of the study | Procedure or surgery | Adult sickle cell patients, pediatric sickle cell patients |
| blood collection M1212 months +/- 2 months after inclusion, a blood collection is performed in the context of routine care for hemoglobin analysis. An additional volume of 300µL of blood is taken for the purposes of the study | Procedure or surgery | Adult sickle cell patients, pediatric sickle cell patients |
Primary outcome
repeatability of fTT measurements
Time frame: 14 months
A series of 10 measurements of a deformability of red blood cells parameter (fTT) on the same blood sample will be performed successively within 24 hours for 4 samples (2 from sickle cell patient and 2 from control or heterozygous patients). The repeatability of the measurements will be determined from these measurements and the effect of a variation in the total number of red blood cells will be analyzed.This study will be reproduced on several blood samples and the measurements will be repeated under the same conditions 24 hours later.
3 secondary outcomes
Effect of ambient temperature during fTT measurement
Time frame: 14 months
Effect of the processing time on fTT measurement
Time frame: 14 months
Correlation of ftt with the collected data
Time frame: 14 months
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 11 May 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Drepanocytosis, run by Assistance Publique Hopitaux De Marseille.
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 1 inclusion and 2 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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Catherine BADENS, Pr (04 91 38 77 87, catherine.badens@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
repeatability of fTT measurements (time frame: 14 months). 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 11 May 2023.