Cohort of Children With Acute Immune or Idiopathic Thrombocytopenic Purpura (ITP) : a Prospective Study in Pays De La Loire

May 29, 2006 updated by: University Hospital, Angers

The objective of this study is to describe a paediatric population presenting an acute idiopathic thrombocytopenic purpura (ITP) and their evolution during their therapy in the region Pays de la Loire. The study will particularly evaluate the quality of life of these patients and their parents.

The secondary objectives are to identify the predictive factors of the complications, the repetitions and the chronicity of the ITP, to estimate the principal parameters of the economic cost of therapy of the children suffering from ITP according to the protocol of therapy, set up in the region Pays de la Loire and the constitution of a blood sample collection which allow a better understanding of the physiopathology of this disease.

It is about a prospective, multicentric clinical epidemiologic study of a paediatric cohort. Patients: 100 children from 0 to 17,99 years suffering from a first discovered ITP. The patients are not included if they present a serious, intercurrent, stabilized chronic pathology or not likely to modify the quality of life of the child and if they present a pathology other than the thrombopenia bringing into play the vital prognosis within a time lower than one year. These patients will be followed for 6 months according to the diagnosis of their ITP.

During the 6 months follow-up of each patient, the study will not carry out more consultations, nor more blood tests than the usual follow-up of a child suffering from ITP. On the other hand, in addition to the J0 questionnaire, it will be requested to the patient and to his family to fill in the questionnaires of quality of life and way of life during the consultations of J8, 1 month, 3 months and 6 months. A check-up of autoimmunity at 6 months will be carried out if the thrombopenia persists (this check-up is usual and not-specific to the study). At the time of the blood test for the control of the platelets at J0 and 6 months, an additional blood sample will be carried out: 5 ml are taken for the children of an age ≤ at 2 years, 10 ml from 2 to 4 years and 15 ml of blood for the children of an age > at 4 years. These blood samples are intended for the constitution of a blood sample collection.

The protocol of therapy of the children suffering from ITP is homogeneous in all centers, this protocol being a consensus established by the network of Oncopaediatrics of the Pays de la Loire. The instituted treatment will be in function of the gravity of the ITP expressed in 4 stages:

Stage I: Platelets > 20 gigas/L and absence of clinical signs. Stage II: Platelets > 10 gigas/L and hemorrhagic signs: haematomas, petechias or occasional epistaxis without repercussion on the daily life.

Stage III: moderate. Platelets > 10.000/mm3 and epistaxis with gauze pluggings or mucous lesions.

Stage IV: severe. Platelets ≤ 10.000/mm3 or fall of 2 grs/dl of haemoglobin with bleedings: epistaxis, melaena or haemorrhages requiring a blood transfusion or an hospitalization and important changes in the activities of the daily life.

Stages I and II do not receive any treatment and benefit from a simple monitoring.

Stages III benefit from either a corticosteroid treatment (Méthylprednisolone or Prednisone) at the dose of 4 mg/kg and per day in 2 intervals during 4 days (maximal dose of 100 mg/day) or a monitoring according to the appreciation of the clinician.

Stages IV profit in first intention from a treatment by Méthylprednisolone or Prednisone at the dose of 4 mg/kg and per day in 2 intervals during 4 days (maximal dose of 100 mg/jour).

The therapeutic attitude and the stadification belong to a regional consensus, established before the study, but each one can decide to apply a treatment according to the gravity of the clinical state of the child.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49933
        • UH of Angers
        • Contact:
        • Sub-Investigator:
          • Xavier RIALLAND, MD
        • Sub-Investigator:
          • Petronella RACHIERU, MD
        • Sub-Investigator:
          • Estelle DARVIOT, MD
      • Cholet, France, 49 325
        • Hospital of Cholet
        • Contact:
        • Principal Investigator:
          • Guy SEGUIN, MD
        • Sub-Investigator:
          • Francis CHOMIENNE, MD
        • Sub-Investigator:
          • Sylvaine POIGNANT, MD
        • Sub-Investigator:
          • Catherine RADET, MD
        • Sub-Investigator:
          • Valérie COURTIN, MD
        • Sub-Investigator:
          • Isabelle GRIMAL, MD
      • La Roche Sur Yon, France, 85 925
        • Hospital of La Roche Sur Yon
        • Contact:
        • Principal Investigator:
          • Nathalie GUILLEY, MD
        • Sub-Investigator:
          • Dominique MEDINGER, MD
      • Laval, France, 53 015
        • Hospital of Laval
        • Contact:
        • Principal Investigator:
          • Joachim BASSIL, MD
        • Sub-Investigator:
          • Eric PARIS, MD
      • Le Mans, France, 72 037
        • Hospital of Le Mans
        • Contact:
        • Principal Investigator:
          • Elaine TARRAL, MD
        • Sub-Investigator:
          • Marie-Chantal CHEVALLIER, MD
      • Nantes, France, 44 093
        • UH of Nantes
        • Principal Investigator:
          • Caroline Thomas, MD
        • Sub-Investigator:
          • Françoise MECHINAUD, MD
      • Saint Nazaire, France, 44 606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children 0 to 17,99 years
  • suffering from a first discovered ITP

Exclusion Criteria:

  • serious, intercurrent, stabilized chronic pathology or not likely to modify the quality of life of the child
  • pathology other than the thrombopenia bringing into play the vital prognosis within a time lower than one year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Collaborators

Ministry of Health, France

Investigators

  • Study Director: Isabelle PELLIER, MD, UH of Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion

December 1, 2008

Study Registration Dates

First Submitted

May 29, 2006

First Submitted That Met QC Criteria

May 29, 2006

First Posted (Estimate)

May 31, 2006

Study Record Updates

Last Update Posted (Estimate)

May 31, 2006

Last Update Submitted That Met QC Criteria

May 29, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC-05-06
  • CCPPRB : 2006/04
  • DGS : 2006/0212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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