Initial Hemato-immunological Profile on the Evolution of Immunological Thrombopenic Purpura.

Predictive Value of the Initial Hemato-immunological Profile on the Evolution of Immunological Thrombopenic Purpura of Children and Adults.

Sponsors

Lead Sponsor: University Hospital, Bordeaux

Source University Hospital, Bordeaux
Brief Summary

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.

Detailed Description

Immune thrombocytopenic purpura (ITP) is a rare autoimmune thrombocytopenia whose incidence is 2 to 5 cases / 100,000 inhabitants / year. The potentially serious haemorrhagic risk is the major issue of management. A recent international consensus conference classifies PTI according to the duration of thrombocytopenia: acute ITP (<3 months), persistent ITP (3-12 months) and chronic ITP (> 12 months) (Rodeghiero 2009). In the acute or persistent phase, polyvalent immunoglobulins (IVIG) and / or corticosteroids are proposed. In the chronic phase, splenectomy is a possible cure for 70% of patients. No predictor of treatment response is known. The pathophysiology of ITP is multifactorial: platelet phagocytosis, mediated by autoantibody, macrophages of the reticuloendothelial system, and destruction in the spleen, genetic background and / or environmental factor favoring the role of certain lymphocyte subpopulations, cytotoxic or regulatory T, via their cytokine environment, abnormalities of thrombopoiesis. ITP affects children as well as adults, but the evolutionary profile is very different. In children, ITP, which is often post-infectious, is acute in 80% of cases, whereas ITP in adults has a chronic evolution in 80% of cases. The primary diagnostic and therapeutic practices are similar. The reasons for these evolutionary differences are not known and little studied. Is the orientation of the hemato-immunological response observed during the first episode of ITP different in children and adults? Do these differences explain the evolutionary specificities of the two age groups? Are there hematologic parameters predictive of a response to initial treatments?

Overall Status Completed
Start Date April 12, 2011
Completion Date March 5, 2014
Primary Completion Date March 5, 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Complete remission yes/no At 12 months of initial diagnosis
Secondary Outcome
Measure Time Frame
Response to the first course of first-line treatments (Immunoglobulin IV or corticosteroid) At Day14
Response to the first course of first-line treatments (Immunoglobulin IV or corticosteroid) At Day 28
Enrollment 70
Condition
Intervention

Intervention Type: Biological

Intervention Name: Collection of biological samples

Description: A collection of biological samples will be carried out, with the remainders of the immunological samples taken on dry tube: the serum of the patients, taken at the initial diagnosis, will be kept frozen at -20 ° C.

Arm Group Label: Single arm

Eligibility

Criteria:

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

Gender: All

Minimum Age: 2 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Carine GRIEB, Dr Principal Investigator University Hospital, Bordeaux
Verification Date

August 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Single arm

Type: Experimental

Description: Study of lymphocyte subpopulations, cytokine assays, identification of autoantibodies, study of CD40 platelet ligand, thrombopoietin assay

Acronym IMMUNOTI
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov