Immune Thrombocytopenic Purpura Clinical Trial
— IMMUNOTIOfficial title:
Predictive Value of the Initial Hemato-immunological Profile on the Evolution of Immunological Thrombopenic Purpura of Children and Adults.
Verified date | August 2019 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to determine the hemato-immunological parameters predictive of the evolution of a Immune thrombocytopenic purpura (ITP) towards chronicity, and to identify possible differences between the child and the adult.
Status | Completed |
Enrollment | 70 |
Est. completion date | March 5, 2014 |
Est. primary completion date | March 5, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility |
Inclusion Criteria: - Minor patients aged 2 to 18 recruited at the Children's Hospital, in the service of Prof. Y. PEREL, Dr. N. ALADJIDI, CEREVANCE, - Adult patients (> 18 years old) recruited at the Haut-Lévêque hospital, Pr JL PELLEGRIN, Pr JF VIALLARD, GECAI, - Patient with acute Immune thrombocytopenic purpura, seen at initial diagnosis or within 8 days (defined as thrombocytopenia <100 G / L, after an infectious cause, drug or related to autoimmune disease, hematological malignancy or deficit Immune have been eliminated, Rodeghiero criteria, 2009). - Patient who received immunoglobulins more than 4 weeks before inclusion - Written consent given by the patient, if he is of age, or by the person (s) having parental authority - Patient affiliated or beneficiary of a social security scheme Exclusion Criteria: - Patient who has received specific treatment from an Immune thrombocytopenic purpura - Patient with secondary Immune thrombocytopenic purpura (hematological malignancy, autoimmune disease, immunodeficiency, pregnancy) - Patient placed under the protection of justice |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete remission yes/no | The status of Immune thrombocytopenic purpura in adult and pediatric patients will be determined at 12 months of initial diagnosis according to the Rodeghiero criteria: complete remission if the platelet count is> 100 G / L. A non-complete remission patient at 12 months will be considered to have a chronic Immune thrombocytopenic purpura. | At 12 months of initial diagnosis | |
Secondary | Response to the first course of first-line treatments (Immunoglobulin IV or corticosteroid) | Defined by the Rodeghiero criteria: complete response (platelet count> 100 G / L and no bleeding), response (platelet count> 30 G / L and increase> 2 times the basal rate and no bleeding), no response (platelet count <30 G / L or increase <2 times the basal rate or bleeding). | At Day14 | |
Secondary | Response to the first course of first-line treatments (Immunoglobulin IV or corticosteroid) | Defined by the Rodeghiero criteria: complete response (platelet count> 100 G / L and no bleeding), response (platelet count> 30 G / L and increase> 2 times the basal rate and no bleeding), no response (platelet count <30 G / L or increase <2 times the basal rate or bleeding). | At Day 28 |
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