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NCT Number: NCT01207037

Prognostic Factors of Acute Splenic Sequestration

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

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Key information

Conditions

Anemia; Drepanocytic Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

3 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necker Hospital

Paris, 75015, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

blood samples and scintigraphy

Procedure

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Study of hematology parameters

    Time frame: after three years

    • 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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Study of Prognostic Factors of Acute Splenic Sequestration in a Cohort of Sickle Cell Disease (SCD) Children Diagnosed at Birth

Acronym: SSADREPA

Important dates

Study start
2010
Primary completion
2014
Study completion
2017
First posted
Sep 22, 2010
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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