Sickle Cell DiseaseSCD-TGANCT05376046
Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease (SCD-TGA)
An observational study of Sickle Cell Disease and Vaso-occlusive Crisis, run by BILLOIR at 1 site in France.
Trial summary
Sickle cell disease (SCD) is an inherited haemoglobinopathy disorder caused by mutations in HBB gene with amino-acid substitution on β globin chain. The consequence is synthesis of altered haemoglobin S (HbS) which polymerises in red blood cell (RBC) at deoxygenated state. 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, Vaso-occlusive Crisis
- What is being tested?
- Erythrocytic parameters and thrombin generation assay measurement
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 1 Sep 2026
- How long will I take part?
- 5 Years
- 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: All patients in the study were diagnosed and treated for SCD at Rouen University Hospital. Patients were included during annual visit in our tertiary centre. Patients with VOC were included less than 24hours after admission to emergency department. All patients treated with hydroxyurea have been treated for at least three years. All patients received a systematic annual visit to determine VOC development in the year. Patients were analyzed in four subgroups based on genotype and clinical status: * homozygous SCD (S/S) or β0 thalassemia (S/β0) at steady state; * homozygous SCD with α3.7 thalassemia (S/Sα3.7) at steady state; * heterozygous SCD with C haemoglobin (S/C) or β+ thalassemia (S/β+)at steady state; * patients hospitalized for VOC with any genotype.
Who may be able to join
- Sickle cell disease
Who cannot join
- <18 years
- pregnancy
- Patient under protective guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Rouen university Hospital
Rouen, 76000
Paul Billoir, PhD, associate professor, +33232888129, paul.billoir@chu-rouen.fr
About this study
Official title: Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease
Sickle cell disease (SCD) is an inherited haemoglobinopathy disorder caused by mutations in HBB gene with amino-acid substitution on β globin chain. The consequence is synthesis of altered haemoglobin S (HbS) which polymerises in red blood cell (RBC) at deoxygenated state. SCD is associated with chronic haemolytic anaemia, vaso-occlusive crisis (VOC) leading to frequent hospitalisation.
The aim of the study was to to investigate whether a combination of routine laboratory biomarkers of haemolysis could be used to predict VOC development in confirmed SCD patients.
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis
- Being tested
- Erythrocytic parameters and thrombin generation assay measurement
- Keywords
- sickle cell disease, vaso-occlusive crisis, reticulocyte count, thrombin generation assay, hypercoagulability
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythrocytic parameters and thrombin generation assay measurementBiological
Erythrocytic parameters and thrombin generation assay measurement
| Study group | Role | What they receive |
|---|---|---|
| Sickle cell disease | Confirmed sickle cell disease withHaemoglobin profile was determined by high performance liquid chromatography (HPLC) (Variant II Biorad, California, United States), by capillary electrophoresis on Capillarys 3 Octa® (Kit hydragel hémoglobine Sebia, Lisses, France) and iso-electrofocalisation.
Patients were included during injury evaluation in our tertiary centre. Receives: Biological: Erythrocytic parameters and thrombin generation assay measurement | |
| Healthy | 25 healthy controls matched on age and gender Receives: Biological: Erythrocytic parameters and thrombin generation assay measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalisation for Vaso-occlusive crisis within one years
Following injury consultation, evaluation of biological markers predicting vaso-occlusive crisis requiring hospitalisation in the year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Sep 2018
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- BILLOIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, BILLOIR, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376046
- Sponsor's protocol ID
- 2021/0328/OB
- Acronym
- SCD-TGA
- Status last verified
- May 2022
- First submitted
- 29 Apr 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Feugray G, Grall M, Gillardin B, Burdeau J, Ozanne N, Dumesnil C, Fauvel C, Billoir P. Hemoglobin and High-Density Lipoprotein as Biomarker of Left Atrial Dilatation in Sickle Cell Disease. EJHaem. 2025 Aug 22;6(4):e70135. doi: 10.1002/jha2.70135. eCollection 2025 Aug.
PubMed 40862241
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT05376046
- Acronym / sponsor ID
- SCD-TGA / 2021/0328/OB
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis
- Keywords
- sickle cell disease, vaso-occlusive crisis, reticulocyte count, thrombin generation assay, hypercoagulability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- BILLOIRUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 17 May 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 inherited haemoglobinopathy disorder caused by mutations in HBB gene with amino-acid substitution on β globin chain. The consequence is synthesis of altered haemoglobin S (HbS) which polymerises in red blood cell (RBC) at deoxygenated state. SCD is associated with chronic haemolytic anaemia, vaso-occlusive crisis (VOC) leading to frequent hospitalisation.
The aim of the study was to to investigate whether a combination of routine laboratory biomarkers of haemolysis could be used to predict VOC development in confirmed SCD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sickle cell disease | – | Biological: Erythrocytic parameters and thrombin generation assay measurementConfirmed sickle cell disease withHaemoglobin profile was determined by high performance liquid chromatography (HPLC) (Variant II Biorad, California, United States), by capillary electrophoresis on Capillarys 3 Octa® (Kit hydragel hémoglobine Sebia, Lisses, France) and iso-electrofocalisation. Patients were included during injury evaluation in our tertiary centre. |
| Healthy | – | Biological: Erythrocytic parameters and thrombin generation assay measurement25 healthy controls matched on age and gender |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in the study were diagnosed and treated for SCD at Rouen University Hospital. Patients were included during annual visit in our tertiary centre. Patients with VOC were included less than 24hours after admission to emergency department. All patients treated with hydroxyurea have been treated for at least three years. All patients received a systematic annual visit to determine VOC development in the year. Patients were analyzed in four subgroups based on genotype and clinical status: * homozygous SCD (S/S) or β0 thalassemia (S/β0) at steady state; * homozygous SCD with α3.7 thalassemia (S/Sα3.7) at steady state; * heterozygous SCD with C haemoglobin (S/C) or β+ thalassemia (S/β+)at steady state; * patients hospitalized for VOC with any genotype.
Key inclusion criteria (1 listed)
- Sickle cell disease
Key exclusion criteria (3 listed)
- <18 years
- pregnancy
- Patient under protective guardianship or curatorship
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 |
|---|---|---|
| Erythrocytic parameters and thrombin generation assay measurementErythrocytic parameters and thrombin generation assay measurement | Biological | Healthy, Sickle cell disease |
Primary outcome
Hospitalisation for Vaso-occlusive crisis within one years
Time frame: 1 year
Following injury consultation, evaluation of biological markers predicting vaso-occlusive crisis requiring hospitalisation in the year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 40862241Feugray G, Grall M, Gillardin B, Burdeau J, Ozanne N, Dumesnil C, Fauvel C, Billoir P. Hemoglobin and High-Density Lipoprotein as Biomarker of Left Atrial Dilatation in Sickle Cell Disease. EJHaem. 2025 Aug 22;6(4):e70135. doi: 10.1002/jha2.70135. eCollection 2025 Aug.
- 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. This study is not recruiting at the moment.
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 and Vaso-occlusive Crisis, run by BILLOIR 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalisation for Vaso-occlusive crisis within one years (time frame: 1 year). 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 NCT05376046, 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 24 May 2022.