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临床试验/NCT04323644
NCT04323644Unknown不适用

Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)

University of Birmingham1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
30-day mortality

研究概览

简要总结

CovidSurg will capture real-world international data, to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. This shared international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, ultimately improving their clinical care.

详细描述

There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery. Capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care.

The primary aim of the study is to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. In doing so, this will inform future risk stratification, decision making, and patient consent.

CovidSurg is an investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing ANY type of surgery in an operating theatre, this includes obstetrics
  • The patient had COVID-19 infection either at the time of surgery or within 30 days of surgery, based on
  • (i) positive COVID-19 lab test or computed tomography (CT) chest scan
  • (ii) clinical diagnosis (no COVID-19 lab test or CT chest performed)

排除标准

  • If COVID-19 infection is diagnosed >30 days after discharge, the patient should not be included.

结局指标

主要结局

30-day mortality

时间窗: 30 days

Death up to 30-days post surgery

次要结局

  • 7-day mortality(7 days post surgery)
  • 30-day reoperation(Up to 30-days post surgery)
  • Postoperative ICU admission(Up to 30 days post surgery)
  • Postoperative respiratory failure(Up to 30 days post surgery)
  • Postoperative acute respiratory distress syndrome (ARDS)(Up to 30 days post surgery)
  • Postoperative sepsis(Up to 30 days post surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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