Immunological Markers in Adult Patients With Immune Thrombocytopenic Purpura

NCT04056507 | Completed

• 1 other identifier: CHU BX 2011/05
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Immune Thrombocytopenic Purpura; Splenectomy; Status

Keywords

Immunological parameters; Histological parameters

Outcome Measures

Primary Outcomes (1)

• Complete remission (CR) after splenectomy.

  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.

  At the inclusion

Study Arms (2)

ITP group

On frozen spleens of already splenectomized adult ITP patients.

Procedure: Immunolabeling

Control group

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

Procedure: Immunolabeling

Interventions

Immunolabeling PROCEDURE

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

Control group; ITP group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Spleens come from patients with ITP (defined as thrombocytopenia \<100 G / L) after an infectious, drug, autoimmune disease, hematological malignancy or immunodeficiency cause has been eliminated. Rodeghiero, 2009) who received a splenectomy to treat their condition in the department of Professor JL Pellegrin.

You may qualify if:

• 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).

You may not qualify if:

• Opposition of the patient.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

This work is done on frozen female rats of already splenectomized adult ITP patients. A notice of no objection will be asked to patients for permission to work on this frozen material. Similarly, 10 control rats, from patients who had had a splenectomy at Bordeaux University Hospital following a road accident, will be analyzed and compared to those of the patients. It is a work of immuno-marking on splenic tissue.

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Jean-François VIALLARD, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 14, 2019
• Study Start: April 12, 2012
• Primary Completion: September 30, 2015
• Study Completion: September 30, 2015
• Last Updated: August 14, 2019

Record last verified: 2019-08