Acute Idiopathic Thrombocytopenic Purpura Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | December 2008 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 18 Years |
| Eligibility |
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 |
Observational Model: Defined Population, Time Perspective: Longitudinal
| Country | Name | City | State |
|---|---|---|---|
| France | UH of Angers | Angers | |
| France | Hospital of Cholet | Cholet | |
| France | Hospital of La Roche Sur Yon | La Roche Sur Yon | |
| France | Hospital of Laval | Laval | |
| France | Hospital of Le Mans | Le Mans | |
| France | UH of Nantes | Nantes | |
| France | Hosptal of Saint Nazaire | Saint Nazaire |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Angers | Ministry of Health, France |
France,
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01327872 -
Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects
|
Phase 1 |