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Cohort of Children With Acute Immune or Idiopathic Thrombocytopenic Purpura (ITP) : a Prospective Study in Pays De La Loire
This study is not yet open for participant recruitment.
Verified by University Hospital, Angers, May 2006
Sponsors and Collaborators: University Hospital, Angers
Ministry of Health, France
Information provided by: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT00331357
  Purpose

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.


Condition
Acute Idiopathic Thrombocytopenic Purpura

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: Cohort of Children With Acute Immune or Idiopathic Thrombocytopenic Purpura (ITP) : a Prospective Study in Pays De La Loire

Further study details as provided by University Hospital, Angers:

Estimated Enrollment: 100
Study Start Date: June 2006
Estimated Study Completion Date: December 2008
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331357

Contacts
Contact: isabelle PELLIER, MD IsPellier@chu-angers.fr

Locations
France
UH of Angers
Angers, France, 49933
Hospital of Cholet
Cholet, France, 49 325
Hospital of Laval
Laval, France, 53 015
Hosptal of Saint Nazaire
Saint Nazaire, France, 44 606
Hospital of Le Mans
Le Mans, France, 72 037
UH of Nantes
Nantes, France, 44 093
Hospital of La Roche Sur Yon
La Roche Sur Yon, France, 85 925
Sponsors and Collaborators
University Hospital, Angers
Ministry of Health, France
Investigators
Study Director: Isabelle PELLIER, MD UH of Angers
  More Information

Study ID Numbers: PHRC-05-06, CCPPRB : 2006/04, DGS : 2006/0212
Study First Received: May 29, 2006
Last Updated: May 29, 2006
ClinicalTrials.gov Identifier: NCT00331357  
Health Authority: France : General Health Administration

Keywords provided by University Hospital, Angers:
acute idiopathic thrombocytopenic purpura
paediatric
quality of life

Study placed in the following topic categories:
Purpura
Autoimmune Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Quality of Life
Hemostatic Disorders
Purpura, Thrombocytopenic
Thrombocytopathy
Signs and Symptoms
Thrombocytopenia
Hemorrhagic Disorders
Thrombocytopenic purpura, autoimmune
Purpura, Thrombocytopenic, Idiopathic

Additional relevant MeSH terms:
Skin Manifestations
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009