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临床试验/NCT02862353
NCT02862353已完成不适用

Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
TITIM test positivity

研究概览

简要总结

The drug immune thrombocytopenia (TIM) are the most common drug cytopenias. They result from a peripheral destruction of platelets in the presence of the drug only. They usually involve immunoglobulin G (IgG) directed against either the drug molecule bound to a carrier protein or, by autoimmunity, against a hidden epitope newly exposed as a result of treatment. The most common drugs involved are quinine, some antibiotics, nonsteroidal anti-inflammatory drugs or anticonvulsants but the list is not exhaustive.

in the case of new-onset thrombocytopenia and after eliminating other possible causes, a TIM is suspected but the offending drug is difficult to identify in generally poly-medicated patients.

Several drugs may be suspected and the clinician uses biology for rapid assistance to the "de-prescription" and reduces unnecessary therapeutic substitutions in an always difficult clinical situation.

The Immunology Laboratory of the University Hospital of Saint-Etienne has developed a biological test of thrombocytopenia induction in the presence of the drug and the patient's serum that is to say its antibodies and complement fractions with cytometry reading flow. This Induction Test in vitro TIM (TITIM) is simple, fast, inexpensive, easy to transfer in hospital laboratories. But this test must be validated on well-documented clinical cases.

The purpose of this pilot project is to validate the technical and assess the clinical specificity of the test TITIM for hard imputability drugs validated by a committee of experts combining a posteriori of clinical and biological criteria of routine.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • hospitalized patients with suspicion of thrombocytopenia drug
  • consent signed

排除标准

  • Thrombocytopenia plants such as secondary to the following molecules: antineoplastic (except oxaliplatin which gives TIM), immunosuppressants.
  • Induced thrombocytopenia heparin and IIb / IIIa glycoproteins (abciximab, tirofiban, epifibatide).
  • Presence of anti platelet antibodies allogeneic or autoimmune which are part of the MAIPA test.
  • Patient exposed to at least one suspect molecule does not exist in water-soluble form or drug to which the metabolite is suspected
  • Patients transfused (plasma, platelets) for less than a month
  • Patients with an other bloodline

结局指标

主要结局

TITIM test positivity

时间窗: at baseline

TITIM test is considered positive when there is a decrease in platelet counts at least 10%.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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