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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by University Hospital, Angers.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00331357
First received: May 29, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  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

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Cohort of Children With Acute Immune or Idiopathic Thrombocytopenic Purpura (ITP) : a Prospective Study in Pays De La Loire

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Not yet recruiting
Angers, France, 49933
Contact: Isabelle PELLIER, MD       Ispellier@chu-angers.fr   
Principal Investigator: Isabelle PELLIER, MD         
Sub-Investigator: Xavier RIALLAND, MD         
Sub-Investigator: Petronella RACHIERU, MD         
Sub-Investigator: Estelle DARVIOT, MD         
Hospital of Cholet Not yet recruiting
Cholet, France, 49 325
Contact: Guy SEGUIN, MD       guy.seguin@ch-cholet.fr   
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         
Hospital of La Roche Sur Yon Not yet recruiting
La Roche Sur Yon, France, 85 925
Contact: Nathalie GUILLEY, MD       nathalie.guilley@chd-vendee.fr   
Principal Investigator: Nathalie GUILLEY, MD         
Sub-Investigator: Dominique MEDINGER, MD         
Hospital of Laval Not yet recruiting
Laval, France, 53 015
Contact: Joachim BASSIL, MD       joachim.bassil@chlaval.fr   
Principal Investigator: Joachim BASSIL, MD         
Sub-Investigator: Eric PARIS, MD         
Hospital of Le Mans Not yet recruiting
Le Mans, France, 72 037
Contact: Eliane TARRAL, MD       etarral@ch-lemans.fr   
Principal Investigator: Elaine TARRAL, MD         
Sub-Investigator: Marie-Chantal CHEVALLIER, MD         
UH of Nantes Not yet recruiting
Nantes, France, 44 093
Contact: Caroline THOMAS, MD       caroline.thomas@chu-nantes.fr   
Principal Investigator: caroline THOMAS, MD         
Sub-Investigator: Françoise MECHINAUD, MD         
Sub-Investigator: Nadège CORRADINI, MD         
Hosptal of Saint Nazaire Not yet recruiting
Saint Nazaire, France, 44 606
Contact: Arnaud BOUTET, MD       a.boutet@ch-saintnazaire.fr   
Principal Investigator: Arnaud BOUTET, MD         
Sponsors and Collaborators
University Hospital, Angers
Ministry of Health, France
Investigators
Study Director: Isabelle PELLIER, MD UH of Angers
  More Information

No publications provided by University Hospital, Angers

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00331357     History of Changes
Other Study ID Numbers: PHRC-05-06, CCPPRB : 2006/04, DGS : 2006/0212
Study First Received: May 29, 2006
Last Updated: May 29, 2006
Health Authority: France : General Health Administration

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

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases

ClinicalTrials.gov processed this record on August 27, 2014