Immunological Markers in Adult Patients With Immune Thrombocytopenic Purpura

Completed

• Conditions: Immune Thrombocytopenic Purpura; Splenectomy; Status
• Interventions: Procedure: Immunolabeling

• Registration Number: NCT04056507
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-04-12
• Primary Completion: 2015-09-30
• Study Completion: 2015-09-30
• Status Verified: 2019-08
• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-13
• Last Update Submitted: 2019-08-13
• Study First Posted: 2019-08-14
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ITP group	Immunolabeling	On frozen spleens of already splenectomized adult ITP patients.
Control group	Immunolabeling	On frozen control spleens from patients who had a splenectomy at the Bordeaux University Hospital following a road accident.

Primary Outcome Measures

Name	Time	Method
Complete remission (CR) after splenectomy.	At the inclusion	Determination of ITP status following Rodeghiero criteria : complete remission if platelet count \> 100 G/L. patient who is not on complete remission after splenectomy will be considered to be failing.