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临床试验/NCT04056507
NCT04056507已完成不适用

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

University Hospital, Bordeaux0 个研究点目标入组 80 人开始时间: 2012年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
主要终点
Complete remission (CR) after splenectomy.

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • Opposition of the patient.

结局指标

主要结局

Complete remission (CR) after splenectomy.

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

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