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临床试验/NCT05112705
NCT05112705招募中不适用

Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients (DETECT) Trial

King Abdullah International Medical Research Center2 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2023年3月21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
1,800
试验地点
2
主要终点
90-day mortality

研究概览

简要总结

The DETECT randomized controlled trial addresses the question of whether surveillance ultrasound in critically ill patients by facilitating DVT detection reduces the incidence of PE and lowers all-cause 90-day mortality. The primary outcome is 90-day all-cause mortality.

详细描述

This is an open-label multicenter multinational randomized-controlled trial. All patients admitted to ICU will be screened within the first 48 hours of ICU admission for eligibility. Subjects who meet all criteria for enrollment will be randomized via a password-protected, secure website using a variable-size block concealed computer-generated randomization procedure. Patients will be allocated to twice weekly bilateral lower limb ultrasound or standard care (control) in a 1:1 ratio.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

90-day mortality

时间窗: 90 days

Mortality 90 days post randomization

次要结局

  • Proximal DVT(From randomization date to day 28 or ICU discharge whichever comes first)
  • Pulmonary Embolism(From randomization date and throughout hospital stay up to day 28)
  • Clinically important bleeding(From randomization date and throughout hospital stay up to day 90)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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