Text Size

Prognostic Factors of Acute Splenic Sequestration (SSADREPA)

This study is currently recruiting participants.
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01207037
First received: June 3, 2010
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  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 prognostic factors of acute splenic sequestration in SCD children . Thus the present research project aims at identifying in a forward-looking way prognostic factors of acute splenic sequestration in SCD children by analysing clinical, biological and genetic characteristics in a multicentric cohort of 150 SCD children.


Condition Intervention
Anemia; Drepanocytic
 Procedure: blood samples and scintigraphy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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)


Estimated Enrollment: 50
Study Start Date: August 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 2013 (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
Other Name: blood samples and scintigraphy

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

Ages Eligible for Study:   3 Months to 6 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207037

Contacts
Contact: Valentine Brousse, MD, PhD 0033144381697 valentine.brousse@nck.aphp.fr
Contact: Raphaël Serreau, MD, PhD 0033158411180 raphael.serreau@nck.aphp.fr

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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01207037     History of Changes
Other Study ID Numbers: P071228, 2009-A00142-55
Study First Received: June 3, 2010
Last Updated: November 16, 2012
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hypersplenism
Hematologic Diseases
Splenic Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013