SPLENOTIR: Immunological Markers in Adult Patients With Immune Thrombocytopenic Purpura

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Completed
CT.gov ID
NCT04056507
Collaborator
(none)
80
41.6

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Immunolabeling

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 Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Retrospective Study of Splenic Immunological Markers as Predictive Factors for Response to Splenectomy in Adult Patients Affected by a Immune Thrombocytopenic Purpura
Actual Study Start Date :
Apr 12, 2012
Actual Primary Completion Date :
Sep 30, 2015
Actual Study Completion Date :
Sep 30, 2015

Arms and Interventions

Arm Intervention/Treatment
ITP group

On frozen spleens of already splenectomized adult ITP patients.

Procedure: Immunolabeling
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.

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Bordeaux

Investigators

  • Principal Investigator: Jean-François VIALLARD, Pr, University Hospital, Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT04056507
Other Study ID Numbers:
  • CHU BX 2011/05
First Posted:
Aug 14, 2019
Last Update Posted:
Aug 14, 2019
Last Verified:
Aug 1, 2019
Keywords provided by University Hospital, Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2019