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- Klinische proef NCT00331357
Cohort of Children With Acute Immune or Idiopathic Thrombocytopenic Purpura (ITP) : a Prospective Study in Pays De La Loire
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.
Studie Overzicht
Toestand
Studietype
Inschrijving
Contacten en locaties
Studiecontact
- Naam: Isabelle PELLIER, MD
- E-mail: Ispellier@chu-angers.fr
Studie Locaties
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Angers, Frankrijk, 49933
- UH of Angers
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Contact:
- Isabelle PELLIER, MD
- E-mail: Ispellier@chu-angers.fr
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Onderonderzoeker:
- Xavier RIALLAND, MD
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Onderonderzoeker:
- Petronella RACHIERU, MD
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Onderonderzoeker:
- Estelle DARVIOT, MD
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Cholet, Frankrijk, 49 325
- Hospital of Cholet
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Contact:
- Guy SEGUIN, MD
- E-mail: guy.seguin@ch-cholet.fr
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Hoofdonderzoeker:
- Guy SEGUIN, MD
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Onderonderzoeker:
- Francis CHOMIENNE, MD
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Onderonderzoeker:
- Sylvaine POIGNANT, MD
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Onderonderzoeker:
- Catherine RADET, MD
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Onderonderzoeker:
- Valérie COURTIN, MD
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Onderonderzoeker:
- Isabelle GRIMAL, MD
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La Roche Sur Yon, Frankrijk, 85 925
- Hospital of La Roche Sur Yon
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Contact:
- Nathalie GUILLEY, MD
- E-mail: nathalie.guilley@chd-vendee.fr
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Hoofdonderzoeker:
- Nathalie GUILLEY, MD
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Onderonderzoeker:
- Dominique MEDINGER, MD
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Laval, Frankrijk, 53 015
- Hospital of Laval
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Contact:
- Joachim BASSIL, MD
- E-mail: joachim.bassil@chlaval.fr
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Hoofdonderzoeker:
- Joachim BASSIL, MD
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Onderonderzoeker:
- Eric PARIS, MD
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Le Mans, Frankrijk, 72 037
- Hospital of Le Mans
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Contact:
- Eliane TARRAL, MD
- E-mail: etarral@ch-lemans.fr
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Hoofdonderzoeker:
- Elaine TARRAL, MD
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Onderonderzoeker:
- Marie-Chantal CHEVALLIER, MD
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Nantes, Frankrijk, 44 093
- UH of Nantes
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Hoofdonderzoeker:
- Caroline Thomas, MD
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Onderonderzoeker:
- Françoise MECHINAUD, MD
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Saint Nazaire, Frankrijk, 44 606
- Hosptal of Saint Nazaire
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Contact:
- Arnaud BOUTET, MD
- E-mail: a.boutet@ch-saintnazaire.fr
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Hoofdonderzoeker:
- Arnaud BOUTET, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Isabelle PELLIER, MD, UH of Angers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Ziekten van het immuunsysteem
- Auto-immuunziekten
- Hematologische ziekten
- Bloeding
- Hemorragische aandoeningen
- Bloedstollingsstoornissen
- Manifestaties van de huid
- Trombocytopenie
- Bloedplaatjesstoornissen
- Trombotische microangiopathieën
- Purpura
- Purpura, trombocytopenisch
- Purpura, trombocytopenisch, idiopathisch
Andere studie-ID-nummers
- PHRC-05-06
- CCPPRB : 2006/04
- DGS : 2006/0212
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