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临床试验/NCT04199403
NCT04199403招募中不适用

Assessment of Complication Risk Factors in a French National Cohort of Asplenic Patients

Poitiers University Hospital24 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2020年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
6,000
试验地点
24
主要终点
Assessment of complication risk factors

研究概览

简要总结

Spleen could have been surgically removed for trauma, cancer, auto-immune disease, or to perform a diagnosis. Spleen could be non-functional due to radiotherapy or splenic artery embolism. These patients are at risks of infectious diseases due to encapsulated bacteria, cancer, and thromboembolism disease. The purpose of this study is to assess complications occurring in French patients without spleen and to implement new diagnostic tools for follow-up.

详细描述

Asplenia can be congenital or acquired. Acquired asplenia can be due to diagnostic or therapeutic surgery, splenic artery embolization, or radiotherapy. Incidence of splenectomized patients was estimated between 10 and 15/100 000 persons in 2003. More recent data suggested a decrease in splenectomy due to increase of splenic artery embolization. From 212 to 2016, about 4000 splenectomy had still been performed.

Three different risks are known for asplenic patients: infectious, neoplastic, and thromboembolic. Prevalence rate of infectious complications in splenectomized patients was 3.2% with a mortality rate of 1.4%. A US cohort study including 8149 splenectomized veterans have shown that the risk of cancer was increased, so did the risk of thromboembolic disease, on a 27-year period of follow-up. Pathophysiology of these risks are not well known.

There are very few tools to assess splenic function: Howell-Jolly bodies in red blood cells, scintigraphy. These tools lack sensitivity and are not correlated with complications in asplenic patients.

To better understand how splenic function and how immunity evolves during time in asplenic patients, a longitudinal follow-up could be useful. There may be some differences between splenectomized patients, those who benefited from splenic artery embolization, and those who received radiotherapy. Infectious risk may be different between these three groups. Implementing new tools assessing residual splenic function could improve management of these patients. A prospective follow-up aims at accurately estimate the incidence rate of infectious and non-infectious complications in this population.

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

  • ≥18 year-old
  • With asplenia due to splenectomy, splenic artery embolization or radiotherapy

排除标准

  • Genetic asplenia including sick cell disease

结局指标

主要结局

Assessment of complication risk factors

时间窗: 3 years

Comparison between splenectomy and other type of asplenia for prevalence of infectious diseases, cancer, and thromboembolism disease

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 (24)

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