Anemia; DrepanocyticSSADREPANCT01207037
Prognostic Factors of Acute Splenic Sequestration
A study testing blood samples and scintigraphy in people with Anemia; Drepanocytic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Acute splenic sequestration is a frequent and life threatening complication occurring in approximately 10 % of homozygous children. Maximal incidence is between 6 and 18 months. The investigators formulate the hypothesis that there are clinical, biological and genetic markers predictive of severe complications notably… Read more about this study
- Who is it for?
- Ages 3 to 6 months
- Conditions the study is for
- Anemia; Drepanocytic
- What is being tested?
- blood samples and scintigraphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 12 Aug 2010to 7 Nov 2017
- Phase
- Interventional
- 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 3 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 6 months
- homozygous (SS) or S beta° sickle cell disease diagnosed by neonatal screening
- With no history of acute splenic sequestration
- Signed parental consent
- Patient covered by national insurance scheme or CMU
Who cannot join
- Children with other SCD genotype
- Children with congenital anatomical asplenia
- Children with previous episode of acute splenic sequestration
- Absence of possible follow-up
- Simultaneous enrolment in another biomedical research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Prognostic Factors of Acute Splenic Sequestration in a Cohort of Sickle Cell Disease (SCD) Children Diagnosed at Birth
Acute splenic sequestration is a frequent and life threatening complication occurring in approximately 10 % of homozygous children. Maximal incidence is between 6 and 18 months.
The investigators formulate the hypothesis that there are clinical, biological and genetic markers predictive of severe complications notably acute splenic sequestration in SCD children. The present research project thus aims at analyzing in a forward-looking way the profile of severity by analysing clinical, biological and genetic characteristics in a multicentric cohort of 60 SCD children
Read the detailed description
A prospective multicentric analysis will be conducted in a cohort of 150 SS or S ß ° children diagnosed at birth, included at 3 -5 months and followed up to the age of 24 months.
Five visits, superimposed to the usual follow-up of SCD children, (Recommendations of the High Authority of Health) at 3 months, 6 months, 12 months, 18 months and 24 months will allow a clinical evaluation and an additional sampling of blood (5 mL) at each visit.
The samples will allow 1.analysis of the red blood cell phenotype (adhesion and deformability) and densities 2. the genetic profile 3.to establish a cell bank, a sera bank and a DNA bank, Spleen function in the cohort will be estimated by spleen scintigraphy, coupled with blood markers (pitted cells, Howell-Jolly bodies counts)
- Conditions
- Anemia; Drepanocytic
- Being tested
- blood samples and scintigraphy
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samples and scintigraphyProcedure or surgery
at 3 months, 6 months, 12 months, 18 months and 24 months will allow a clinical evaluation and an additional sampling of blood of 5 mL at each visit Scintigraphy at 6 months and 18 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Not described Receives: Procedure: blood samples and scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of prognostic factors of acute splenic sequestration
- Complete blood count, reticulocyte count, haemoglobin level, VGM, TGMH, CCMH, hematocrit, % foetal haemoglobin (HbF), red blood cell densities (2 mL)
- Deformability of red blood cells
- Expression study of the cell surface molecule: Phosphatidyl serine, CD 36, READ B-CAM, CD 47, ICAM 4, VLA 4. (Cellulotheque = red blood cells frozen in cryopreservative conditions)
- Total LDH, Bilirubine (stigmas of hemolysis)
- Genetic Profil ( DNAtheque)
Measured: after three years
Secondary outcomes (1)
Study of hematology parameters
- Percentage of Howell Jolly's bodies (0,1 mL)
- Percentage of pitted cells (0,5 mL fixed in 4 %)formaldehyde
- Splenic volume, semi-quantitative measure in scintigraphy
- Antibody titers in answer to the antipneumococcic vaccination ( serotheque)
Measured: after three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study start12 Aug 2010
- Primary completion22 Dec 2014
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anemia; DrepanocyticStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Valentine Brousse, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207037
- Sponsor's protocol ID
- P071228
- Other IDs
- 2009-A00142-55
- Acronym
- SSADREPA
- Status last verified
- Aug 2025
- First submitted
- 3 Jun 2010
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
El Hoss S, Cochet S, Marin M, Lapoumeroulie C, Dussiot M, Bouazza N, Elie C, de Montalembert M, Arnaud C, Guitton C, Pellegrino B, Odievre MH, Moati F, Le Van Kim C, Aronovicz YC, El Nemer W, Brousse V. Insights into determinants of spleen injury in sickle cell anemia. Blood Adv. 2019 Aug 13;3(15):2328-2336. doi: 10.1182/bloodadvances.2019000106.
PubMed 31391165Brousse V, El Hoss S, Bouazza N, Arnaud C, Bernaudin F, Pellegrino B, Guitton C, Odievre-Montanie MH, Mames D, Brouzes C, Picard V, Nguyen-Khoa T, Pereira C, Lapoumeroulie C, Pissard S, Gardner K, Menzel S, Le Van Kim C, Colin-Aronovicz Y, Buffet P, Mohandas N, Elie C, Maier-Redelsperger M, El Nemer W, de Montalembert M. Prognostic factors of disease severity in infants with sickle cell anemia: A comprehensive longitudinal cohort study. Am J Hematol. 2018 Nov;93(11):1411-1419. doi: 10.1002/ajh.25260. Epub 2018 Sep 21.
PubMed 30132969Brousse V, Colin Y, Pereira C, Arnaud C, Odievre MH, Boutemy A, Guitton C, de Montalembert M, Lapoumeroulie C, Picot J, Le Van Kim C, El Nemer W. Erythroid Adhesion Molecules in Sickle Cell Anaemia Infants: Insights Into Early Pathophysiology. EBioMedicine. 2014 Dec 18;2(2):154-7. doi: 10.1016/j.ebiom.2014.12.006. eCollection 2015.
PubMed 26137540
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prognostic Factors of Acute Splenic Sequestration in a Cohort of Sickle Cell Disease (SCD) Children Diagnosed at Birth
- ClinicalTrials.gov ID
- NCT01207037
- Acronym / sponsor ID
- SSADREPA / P071228
- Conditions
- Anemia; Drepanocytic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 12 Aug 2010 (actual)
- Primary completion
- 22 Dec 2014 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 22 Sep 2010 (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.
Acute splenic sequestration is a frequent and life threatening complication occurring in approximately 10 % of homozygous children. Maximal incidence is between 6 and 18 months.
The investigators formulate the hypothesis that there are clinical, biological and genetic markers predictive of severe complications notably acute splenic sequestration in SCD children. The present research project thus aims at analyzing in a forward-looking way the profile of severity by analysing clinical, biological and genetic characteristics in a multicentric cohort of 60 SCD children
Detailed description
A prospective multicentric analysis will be conducted in a cohort of 150 SS or S ß ° children diagnosed at birth, included at 3 -5 months and followed up to the age of 24 months.
Five visits, superimposed to the usual follow-up of SCD children, (Recommendations of the High Authority of Health) at 3 months, 6 months, 12 months, 18 months and 24 months will allow a clinical evaluation and an additional sampling of blood (5 mL) at each visit.
The samples will allow 1.analysis of the red blood cell phenotype (adhesion and deformability) and densities 2. the genetic profile 3.to establish a cell bank, a sera bank and a DNA bank, Spleen function in the cohort will be estimated by spleen scintigraphy, coupled with blood markers (pitted cells, Howell-Jolly bodies counts)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Procedure: blood samples and scintigraphy |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 3 to 6 months
- homozygous (SS) or S beta° sickle cell disease diagnosed by neonatal screening
- With no history of acute splenic sequestration
- Signed parental consent
- Patient covered by national insurance scheme or CMU
Key exclusion criteria (5 listed)
- Children with other SCD genotype
- Children with congenital anatomical asplenia
- Children with previous episode of acute splenic sequestration
- Absence of possible follow-up
- Simultaneous enrolment in another biomedical 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 samples and scintigraphyat 3 months, 6 months, 12 months, 18 months and 24 months will allow a clinical evaluation and an additional sampling of blood of 5 mL at each visit Scintigraphy at 6 months and 18 months | Procedure or surgery | Intervention |
Primary outcome
Study of prognostic factors of acute splenic sequestration
Time frame: after three years
* Complete blood count, reticulocyte count, haemoglobin level, VGM, TGMH, CCMH, hematocrit, % foetal haemoglobin (HbF), red blood cell densities (2 mL) * Deformability of red blood cells * Expression study of the cell surface molecule: Phosphatidyl serine, CD 36, READ B-CAM, CD 47, ICAM 4, VLA 4. (Cellulotheque = red blood cells frozen in cryopreservative conditions) * Total LDH, Bilirubine (stigmas of hemolysis) * Genetic Profil ( DNAtheque)
1 secondary outcome
Study of hematology parameters
Time frame: after three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 31391165El Hoss S, Cochet S, Marin M, Lapoumeroulie C, Dussiot M, Bouazza N, Elie C, de Montalembert M, Arnaud C, Guitton C, Pellegrino B, Odievre MH, Moati F, Le Van Kim C, Aronovicz YC, El Nemer W, Brousse V. Insights into determinants of spleen injury in sickle cell anemia. Blood Adv. 2019 Aug 13;3(15):2328-2336. doi: 10.1182/bloodadvances.2019000106.
- Results publication: PubMed 30132969Brousse V, El Hoss S, Bouazza N, Arnaud C, Bernaudin F, Pellegrino B, Guitton C, Odievre-Montanie MH, Mames D, Brouzes C, Picard V, Nguyen-Khoa T, Pereira C, Lapoumeroulie C, Pissard S, Gardner K, Menzel S, Le Van Kim C, Colin-Aronovicz Y, Buffet P, Mohandas N, Elie C, Maier-Redelsperger M, El Nemer W, de Montalembert M. Prognostic factors of disease severity in infants with sickle cell anemia: A comprehensive longitudinal cohort study. Am J Hematol. 2018 Nov;93(11):1411-1419. doi: 10.1002/ajh.25260. Epub 2018 Sep 21.
- Results publication: PubMed 26137540Brousse V, Colin Y, Pereira C, Arnaud C, Odievre MH, Boutemy A, Guitton C, de Montalembert M, Lapoumeroulie C, Picot J, Le Van Kim C, El Nemer W. Erythroid Adhesion Molecules in Sickle Cell Anaemia Infants: Insights Into Early Pathophysiology. EBioMedicine. 2014 Dec 18;2(2):154-7. doi: 10.1016/j.ebiom.2014.12.006. eCollection 2015.
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.
Valentine Brousse, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples and scintigraphy in people with Anemia; Drepanocytic, run by Assistance Publique - Hôpitaux de Paris 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 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: finished, as of the sponsor's last update on 8 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Study of prognostic factors of acute splenic sequestration (time frame: after three years). 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 NCT01207037, which also lists 3 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 8 Sep 2025.