Sickle Cell Disease (SCD)DREPA COAGNCT06619093
Relationship Between Biological Phenotype, Clinical Severity of Sickle Cell Disease, and Blood Coagulation
An observational study of Sickle Cell Disease (SCD), run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Sickle cell disease is characterized by chronic hemolytic anemia and blood rheological alterations. In addition, blood coagulation abnormalities have been reported in patients with sickle cell disease and hemolysis-derived products could be involved. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Sickle Cell Disease (SCD)
- What is being tested?
- blood sampling
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Feb 2025to 1 Feb 2028
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with sickle cell disease, followed regularly by the Sickle Cell Center of Lyon Hospitals (Hospices Civils de Lyon).
Who may be able to join
- Aged 8 years or older
- Under clinical follow-up for a diagnosis of sickle cell disease, specifically genotypes S/S, S/beta0, or S/C
- Patient covered by a social security or equivalent health insurance plan
- Collection of the non-opposition for adults
- Information of the minor and collection of the non-opposition from both parents
Who cannot join
- Patient who has undergone a transfusion or therapeutic phlebotomy within the 3 months prior to inclusion
- Patient participating in another interventional research protocol that may interfere with the present protocol (at the investigator\'s discretion)
- Patient under guardianship, curatorship, or legal protection
- Patient subject to a legal protection measure
- Person admitted to a health or social care institution for purposes other than research
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Philippe CONNES, Pr contact
France2 sites
Insitut Hématologique et Oncologique Pédiatrique (IHOPe)
Lyon, 69008
Corine Halfon-Domenech, Dr, +33 4 69 16 65 50, Carine.HALFONDOMENECH@ihope.fr
Service de Médecine Interne - Hôpital Edouard Herriot
Lyon, 69008
Solène Poutrel, Dr, solene.poutrel@chu-lyon.fr
About this study
Sickle cell disease is characterized by chronic hemolytic anemia and blood rheological alterations. In addition, blood coagulation abnormalities have been reported in patients with sickle cell disease and hemolysis-derived products could be involved. The investigators hypothesized that patients with sickle cell disease and severe hemolysis (Lactate Dehydrogenase level \> 484 IU/L) could have an increased risk of hypercoagulable state and subsequent thromboembolic complications.
- Conditions
- Sickle Cell Disease (SCD)
- Being tested
- blood sampling
- Keywords
- Hemolysis, Coagulation, Red blood cell, Sickle cell disease
- Medical subject headings
- Anemia, Sickle Cell, Hemolysis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
3 additional citrate tubes (2.7mL)
| Study group | Role | What they receive |
|---|---|---|
| High hemolytic group | Lactate Dehydrogenase Level > 484 IU/L Receives: Other: blood sampling | |
| Low hemolytic group | Lactacte Dehydrogenase Level less or equal to 484 IU/L Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall coagulation activity
To compare the overall coagulation activity (measurement of in vitro clot formation by rotary thromboelastometry (ROTEM)) between sickle cell patients with a severe haemolytic phenotype and those with a less severe haemolytic phenotype.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell Disease (SCD)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire Interuniversitaire de Biologie de la Motricité (UCBL1) UR7424
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619093
- Sponsor's protocol ID
- 69HCL24_0679
- Acronym
- DREPA COAG
- Status last verified
- Jan 2025
- First submitted
- 26 Sep 2024
- Last updated
- 15 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Biological Phenotype, Clinical Severity of Sickle Cell Disease, and Blood Coagulation
- ClinicalTrials.gov ID
- NCT06619093
- Acronym / sponsor ID
- DREPA COAG / 69HCL24_0679
- Conditions
- Sickle Cell Disease (SCD)
- Keywords
- Hemolysis, Coagulation, Red blood cell, Sickle cell disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Laboratoire Interuniversitaire de Biologie de la Motricité (UCBL1) UR7424
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 1 Oct 2024 (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 and blood rheological alterations. In addition, blood coagulation abnormalities have been reported in patients with sickle cell disease and hemolysis-derived products could be involved. The investigators hypothesized that patients with sickle cell disease and severe hemolysis (Lactate Dehydrogenase level \> 484 IU/L) could have an increased risk of hypercoagulable state and subsequent thromboembolic complications.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High hemolytic group | – | Other: blood samplingLactate Dehydrogenase Level > 484 IU/L |
| Low hemolytic group | – | Other: blood samplingLactacte Dehydrogenase Level less or equal to 484 IU/L |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with sickle cell disease, followed regularly by the Sickle Cell Center of Lyon Hospitals (Hospices Civils de Lyon).
Key inclusion criteria (5 listed)
- Aged 8 years or older
- Under clinical follow-up for a diagnosis of sickle cell disease, specifically genotypes S/S, S/beta0, or S/C
- Patient covered by a social security or equivalent health insurance plan
- Collection of the non-opposition for adults
- Information of the minor and collection of the non-opposition from both parents
Key exclusion criteria (5 listed)
- Patient who has undergone a transfusion or therapeutic phlebotomy within the 3 months prior to inclusion
- Patient participating in another interventional research protocol that may interfere with the present protocol (at the investigator\'s discretion)
- Patient under guardianship, curatorship, or legal protection
- Patient subject to a legal protection measure
- Person admitted to a health or social care institution for purposes other than research
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 sampling3 additional citrate tubes (2.7mL) | Other | High hemolytic group, Low hemolytic group |
Primary outcome
Overall coagulation activity
Time frame: Baseline
To compare the overall coagulation activity (measurement of in vitro clot formation by rotary thromboelastometry (ROTEM)) between sickle cell patients with a severe haemolytic phenotype and those with a less severe haemolytic phenotype.
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 15 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.
Philippe CONNES, Pr contact
2 sites 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 (SCD), run by Hospices Civils de Lyon at 2 sites 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 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: opening soon, as of the sponsor's last update on 15 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 2 sites 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 Corine Halfon-Domenech, Dr (0033469166550 ext. +33, Carine.HALFONDOMENECH@ihope.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall coagulation activity (time frame: Baseline). 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 15 Jan 2025.