Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04056507
Acronym
SPLENOTIR
Enrollment
80
Registered
2019-08-14
Start date
2012-04-12
Completion date
2015-09-30
Last updated
2019-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Thrombocytopenic Purpura, Splenectomy; Status

Keywords

Immunological parameters, Histological parameters

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.

Interventions

PROCEDUREImmunolabeling

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

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
Complete remission (CR) after splenectomy.At the inclusionDetermination 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026