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Prognostic Factors of Acute Splenic Sequestration (SSADREPA)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01207037
First Posted: September 22, 2010
Last Update Posted: August 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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


Condition Intervention
Anemia; Drepanocytic Procedure: blood samples and scintigraphy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of Prognostic Factors of Acute Splenic Sequestration in a Cohort of Sickle Cell Disease (SCD) Children Diagnosed at Birth

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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)


Enrollment: 58
Study Start Date: August 2010
Estimated Study Completion Date: April 2018
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention Procedure: blood samples and scintigraphy
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

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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207037


Locations
France
Necker Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Valentine Brousse, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01207037     History of Changes
Other Study ID Numbers: P071228
2009-A00142-55 ( Other Identifier: AFSSAPS )
First Submitted: June 3, 2010
First Posted: September 22, 2010
Last Update Posted: August 26, 2016
Last Verified: January 2016