Immunological Markers in Adult Patients With Immune Thrombocytopenic Purpura

Retrospective Study of Splenic Immunological Markers as Predictive Factors for Response to Splenectomy in Adult Patients Affected by a Immune Thrombocytopenic Purpura

Sponsors

Lead Sponsor: University Hospital, Bordeaux

Source 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.

Overall Status Completed
Start Date April 12, 2012
Completion Date September 30, 2015
Primary Completion Date September 30, 2015
Study Type Observational
Primary Outcome
Measure Time Frame
Complete remission (CR) after splenectomy. At the inclusion
Enrollment 80
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Immunolabeling

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

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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.

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jean-François VIALLARD, Pr Principal Investigator University Hospital, Bordeaux
Verification Date

August 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: ITP group

Description: On frozen spleens of already splenectomized adult ITP patients.

Label: Control group

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

Acronym SPLENOTIR
Study Design Info

Observational Model: Case-Only

Time Perspective: Retrospective

Source: ClinicalTrials.gov