Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331357
Status:
UNKNOWN
Last Update Posted:
2006-05-31
First Post:
2006-05-29
Brief Title:
Cohort of Children With Acute Immune or Idiopathic Thrombocytopenic Purpura ITP a Prospective Study in Pays De La Loire
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
Cohort of Children With Acute Immune or Idiopathic Thrombocytopenic Purpura ITP a Prospective Study in Pays De La Loire
Status:
UNKNOWN
Status Verified Date:
2006-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 1799 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 gigasL and absence of clinical signs Stage II Platelets 10 gigasL and hemorrhagic signs haematomas petechias or occasional epistaxis without repercussion on the daily life
Stage III moderate Platelets 10000mm3 and epistaxis with gauze pluggings or mucous lesions
Stage IV severe Platelets 10000mm3 or fall of 2 grsdl 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 mgkg and per day in 2 intervals during 4 days maximal dose of 100 mgday 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 mgkg and per day in 2 intervals during 4 days maximal dose of 100 mgjour
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
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 1799 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 gigasL and absence of clinical signs Stage II Platelets 10 gigasL and hemorrhagic signs haematomas petechias or occasional epistaxis without repercussion on the daily life
Stage III moderate Platelets 10000mm3 and epistaxis with gauze pluggings or mucous lesions
Stage IV severe Platelets 10000mm3 or fall of 2 grsdl 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 mgkg and per day in 2 intervals during 4 days maximal dose of 100 mgday 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 mgkg and per day in 2 intervals during 4 days maximal dose of 100 mgjour
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DGS 20060212 | None | None | None |
| CCPPRB 200604 | None | None | None |