Immunological Markers in Adult Patients With Immune Thrombocytopenic Purpura

NCT ID: NCT04056507

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-12

Study Completion Date

2015-09-30

Brief Summary

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The aim of this study is to determine histological immunological parameters, sought on splenectomy pieces that may explain the failure or success of splenectomy in patients with ITP who had a splenectomy to treat their ITP(Immune thrombocytopenic purpura).

Detailed Description

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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.

At present, no predictive factor of splenectomy success has been identified. The aim of this study is to determine histological immunological parameters, sought on splenectomy pieces that may explain the failure or success of splenectomy in patients with ITP who had a splenectomy to treat their ITP.

Conditions

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Immune Thrombocytopenic Purpura Splenectomy; Status

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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ITP group

On frozen spleens of already splenectomized adult ITP patients.

Immunolabeling

Intervention Type PROCEDURE

Immunolabeling of abnormalities observed by the cell study in flow cytometry.

Control group

On frozen control spleens from patients who had a splenectomy at the Bordeaux University Hospital following a road accident.

Immunolabeling

Intervention Type PROCEDURE

Immunolabeling of abnormalities observed by the cell study in flow cytometry.

Interventions

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Immunolabeling

Immunolabeling of abnormalities observed by the cell study in flow cytometry.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* The analyzed spleens belong to the collection of biological samples declared to the ministry by the Laboratory of Pathology of Haut-Lévêque Hospital (Dr Parrens).

Exclusion Criteria

* Opposition of the patient.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-François VIALLARD, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Other Identifiers

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CHU BX 2011/05

Identifier Type: -

Identifier Source: org_study_id

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