Sickle Cell DiseaseDREPADENSENCT02887118
Dense Red Blood Cells in Sickle Cell Children
An observational study of Sickle Cell Disease, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
Quantitative and prognostic evaluation of dense red blood cells in sickle cell children: preliminary single center study from the Creteil pediatric cohort. Read more about this study
- Who is it for?
- Ages 18 months to 18 years
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to 7 Jul 2019
- 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 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients with sickle cell disease followed regularly in the CHI creteil hospital aged from 18 months to 18 years old.
Who may be able to join
- Age: 18 months-18 years
- Patient with sickle cell disease namely SS, or S / Beta0 or S / Beta +
- Patient regularly followed in the pediatric cohort of the CHI Creteil
- Patient Hospitalized for an annual check-up
- With or without intensification by Hydroxycarbamide
- patient who haven't been transfused within 3 months
- Whose parents have given their informed consent
- Patients insured to the French social scheme
Who cannot join
- Sickle cell SC disease
- Having received an allogeneic bone marrow transplantation
- Under regular transfusion program
- Having received a transfusion within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative and Prognostic Evaluation of Dense Red Blood Cells in Sickle Cell Children: Single-center Study From the Creteil (France) Pediatric Cohort
Quantitative and prognostic evaluation of dense red blood cells in sickle cell children: preliminary single center study from the Creteil pediatric cohort.
Read the detailed description
An association between red blood cell density and hemolytic parameters, and clinical manifestations has been demonstrated in adults with sickle cell anemia.
This factor has not been studied in children. The identification of predictive biomarkers of disease severity, especially of specific pediatric complications (cerebral vasculopathy, splenic sequestration, Dactylitis) would be useful for optimal care of the children and early intensification Red blood cell density might be one of these prognostic factors.
- Conditions
- Sickle Cell Disease
- Keywords
- Erythrocytes, Sickle Cell Disease
- 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 |
|---|---|---|
| Common arm | Children with sickle cell anemia will be included. Blood samples of all the included patients will be collected during a day-hospitalization for a planned chek-up. For all these patients the number of dense erythrocytes will be evaluated |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of dense red blood cells (DRBC)
Evaluation of the number of dense red blood cells in the blood of affected children
Measured: 1 day
Secondary outcomes (9)
biological profile
hemolytic parameters (LDH, bilirubin, Hemoglobin level)
Measured: 1 day
Number of patients with velocities > 200 cm/sec on transcranial doppler
Cerebral vasculopathy (correlation with patients with abnormal velocities on transcranial doppler (TCD)(> 200 cm/sec)
History of dactylitis History of ischemic lesions on magnetic resonance imaging (MRI)
Measured: 1 day
Number of patients with history of acute splenic sequestration,
Measured: 1 day
Number of patients with history of acute chest syndrome
Measured: 1 day
Number of patients with History of dactylitis
Measured: 1 day
Number of patients with history of abnormal transcranial doppler (TCD) (≥ 200 cm/sec)
Measured: 1 day
Number of patients with history of ischemic lesions on magnetic resonance imaging (MRI)
Measured: 1 day
Number of patients with hydroxycarbamide treatment
effect of hydroxycarbamide on the % DRBC
Measured: 1 day
Number of dense red blood cells
number of dense red blood cells in the pediatric population with no known blood condition
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startDec 2015
- Primary completion7 Jul 2019
- Study completion7 Jul 2019
Why it stopped: The recruiting centre was no longer presenting new patients for inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corinne Pondarré, Centre Hospitalier Intercommunal Creteil
- Investigators
- Corinne Pondarre, MD PhD, Principal investigator, CHI Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887118
- Sponsor's protocol ID
- DREPADENSE
- Acronym
- DREPADENSE
- Status last verified
- Jul 2020
- First submitted
- 21 Jun 2016
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Miller ST, Sleeper LA, Pegelow CH, Enos LE, Wang WC, Weiner SJ, Wethers DL, Smith J, Kinney TR. Prediction of adverse outcomes in children with sickle cell disease. N Engl J Med. 2000 Jan 13;342(2):83-9. doi: 10.1056/NEJM200001133420203.
PubMed 10631276Benkerrou M, Alberti C, Couque N, Haouari Z, Ba A, Missud F, Boizeau P, Holvoet L, Ithier G, Elion J, Baruchel A, Ducrocq R. Impact of glucose-6-phosphate dehydrogenase deficiency on sickle cell anaemia expression in infancy and early childhood: a prospective study. Br J Haematol. 2013 Dec;163(5):646-54. doi: 10.1111/bjh.12590. Epub 2013 Oct 10.
PubMed 24117340Quinn CT, Shull EP, Ahmad N, Lee NJ, Rogers ZR, Buchanan GR. Prognostic significance of early vaso-occlusive complications in children with sickle cell anemia. Blood. 2007 Jan 1;109(1):40-5. doi: 10.1182/blood-2006-02-005082. Epub 2006 Aug 29.
PubMed 16940426Bernaudin F, Verlhac S, Arnaud C, Kamdem A, Chevret S, Hau I, Coic L, Leveille E, Lemarchand E, Lesprit E, Abadie I, Medejel N, Madhi F, Lemerle S, Biscardi S, Bardakdjian J, Galacteros F, Torres M, Kuentz M, Ferry C, Socie G, Reinert P, Delacourt C. Impact of early transcranial Doppler screening and intensive therapy on cerebral vasculopathy outcome in a newborn sickle cell anemia cohort. Blood. 2011 Jan 27;117(4):1130-40; quiz 1436. doi: 10.1182/blood-2010-06-293514. Epub 2010 Nov 10.
PubMed 21068435Bartolucci P, Brugnara C, Teixeira-Pinto A, Pissard S, Moradkhani K, Jouault H, Galacteros F. Erythrocyte density in sickle cell syndromes is associated with specific clinical manifestations and hemolysis. Blood. 2012 Oct 11;120(15):3136-41. doi: 10.1182/blood-2012-04-424184. Epub 2012 Aug 23.
PubMed 22919030Thornburg CD, Files BA, Luo Z, Miller ST, Kalpatthi R, Iyer R, Seaman P, Lebensburger J, Alvarez O, Thompson B, Ware RE, Wang WC; BABY HUG Investigators. Impact of hydroxyurea on clinical events in the BABY HUG trial. Blood. 2012 Nov 22;120(22):4304-10; quiz 4448. doi: 10.1182/blood-2012-03-419879. Epub 2012 Aug 22.
PubMed 22915643Yawn BP, Buchanan GR, Afenyi-Annan AN, Ballas SK, Hassell KL, James AH, Jordan L, Lanzkron SM, Lottenberg R, Savage WJ, Tanabe PJ, Ware RE, Murad MH, Goldsmith JC, Ortiz E, Fulwood R, Horton A, John-Sowah J. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014 Sep 10;312(10):1033-48. doi: 10.1001/jama.2014.10517.
PubMed 25203083
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative and Prognostic Evaluation of Dense Red Blood Cells in Sickle Cell Children: Single-center Study From the Creteil (France) Pediatric Cohort
- ClinicalTrials.gov ID
- NCT02887118
- Acronym / sponsor ID
- DREPADENSE / DREPADENSE
- Conditions
- Sickle Cell Disease
- Keywords
- Erythrocytes, Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The recruiting centre was no longer presenting new patients for inclusion
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 7 Jul 2019 (actual)
- Study completion
- 7 Jul 2019 (actual)
- First posted
- 1 Sep 2016 (estimated)
- 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.
Quantitative and prognostic evaluation of dense red blood cells in sickle cell children: preliminary single center study from the Creteil pediatric cohort.
Detailed description
An association between red blood cell density and hemolytic parameters, and clinical manifestations has been demonstrated in adults with sickle cell anemia.
This factor has not been studied in children. The identification of predictive biomarkers of disease severity, especially of specific pediatric complications (cerebral vasculopathy, splenic sequestration, Dactylitis) would be useful for optimal care of the children and early intensification Red blood cell density might be one of these prognostic factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Common arm | – | –Children with sickle cell anemia will be included. Blood samples of all the included patients will be collected during a day-hospitalization for a planned chek-up. For all these patients the number of dense erythrocytes will be evaluated |
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients with sickle cell disease followed regularly in the CHI creteil hospital aged from 18 months to 18 years old.
Key inclusion criteria (8 listed)
- Age: 18 months-18 years
- Patient with sickle cell disease namely SS, or S / Beta0 or S / Beta +
- Patient regularly followed in the pediatric cohort of the CHI Creteil
- Patient Hospitalized for an annual check-up
- With or without intensification by Hydroxycarbamide
Key exclusion criteria (4 listed)
- Sickle cell SC disease
- Having received an allogeneic bone marrow transplantation
- Under regular transfusion program
- Having received a transfusion within 3 months
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
number of dense red blood cells (DRBC)
Time frame: 1 day
Evaluation of the number of dense red blood cells in the blood of affected children
9 secondary outcomes
biological profile
Time frame: 1 day
Number of patients with velocities > 200 cm/sec on transcranial doppler
Time frame: 1 day
Number of patients with history of acute splenic sequestration,
Time frame: 1 day
Number of patients with history of acute chest syndrome
Time frame: 1 day
Number of patients with History of dactylitis
Time frame: 1 day
Number of patients with history of abnormal transcranial doppler (TCD) (≥ 200 cm/sec)
Time frame: 1 day
Number of patients with history of ischemic lesions on magnetic resonance imaging (MRI)
Time frame: 1 day
Number of patients with hydroxycarbamide treatment
Time frame: 1 day
Number of dense red blood cells
Time frame: 1 day
Results and safety
The study was stopped early (reason given: The recruiting centre was no longer presenting new patients for inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Background: PubMed 10631276Miller ST, Sleeper LA, Pegelow CH, Enos LE, Wang WC, Weiner SJ, Wethers DL, Smith J, Kinney TR. Prediction of adverse outcomes in children with sickle cell disease. N Engl J Med. 2000 Jan 13;342(2):83-9. doi: 10.1056/NEJM200001133420203.
- Background: PubMed 24117340Benkerrou M, Alberti C, Couque N, Haouari Z, Ba A, Missud F, Boizeau P, Holvoet L, Ithier G, Elion J, Baruchel A, Ducrocq R. Impact of glucose-6-phosphate dehydrogenase deficiency on sickle cell anaemia expression in infancy and early childhood: a prospective study. Br J Haematol. 2013 Dec;163(5):646-54. doi: 10.1111/bjh.12590. Epub 2013 Oct 10.
- Background: PubMed 16940426Quinn CT, Shull EP, Ahmad N, Lee NJ, Rogers ZR, Buchanan GR. Prognostic significance of early vaso-occlusive complications in children with sickle cell anemia. Blood. 2007 Jan 1;109(1):40-5. doi: 10.1182/blood-2006-02-005082. Epub 2006 Aug 29.
- Background: PubMed 21068435Bernaudin F, Verlhac S, Arnaud C, Kamdem A, Chevret S, Hau I, Coic L, Leveille E, Lemarchand E, Lesprit E, Abadie I, Medejel N, Madhi F, Lemerle S, Biscardi S, Bardakdjian J, Galacteros F, Torres M, Kuentz M, Ferry C, Socie G, Reinert P, Delacourt C. Impact of early transcranial Doppler screening and intensive therapy on cerebral vasculopathy outcome in a newborn sickle cell anemia cohort. Blood. 2011 Jan 27;117(4):1130-40; quiz 1436. doi: 10.1182/blood-2010-06-293514. Epub 2010 Nov 10.
- Background: PubMed 22919030Bartolucci P, Brugnara C, Teixeira-Pinto A, Pissard S, Moradkhani K, Jouault H, Galacteros F. Erythrocyte density in sickle cell syndromes is associated with specific clinical manifestations and hemolysis. Blood. 2012 Oct 11;120(15):3136-41. doi: 10.1182/blood-2012-04-424184. Epub 2012 Aug 23.
- Background: PubMed 22915643Thornburg CD, Files BA, Luo Z, Miller ST, Kalpatthi R, Iyer R, Seaman P, Lebensburger J, Alvarez O, Thompson B, Ware RE, Wang WC; BABY HUG Investigators. Impact of hydroxyurea on clinical events in the BABY HUG trial. Blood. 2012 Nov 22;120(22):4304-10; quiz 4448. doi: 10.1182/blood-2012-03-419879. Epub 2012 Aug 22.
- Background: PubMed 25203083Yawn BP, Buchanan GR, Afenyi-Annan AN, Ballas SK, Hassell KL, James AH, Jordan L, Lanzkron SM, Lottenberg R, Savage WJ, Tanabe PJ, Ware RE, Murad MH, Goldsmith JC, Ortiz E, Fulwood R, Horton A, John-Sowah J. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014 Sep 10;312(10):1033-48. doi: 10.1001/jama.2014.10517.
- 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.
Corinne Pondarre, MD PhD principal investigator
CHI Créteil
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 Intercommunal Creteil 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 Jul 2020. 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?
The study was stopped early (reason given: The recruiting centre was no longer presenting new patients for inclusion). Results are not available in the source record.
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?
number of dense red blood cells (DRBC) (time frame: 1 day). 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 NCT02887118, which also lists 7 linked publications.
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 Jul 2020.