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临床试验/NCT05977452
NCT05977452已完成不适用

The Risk Assessment Scale for Peripherally Inserted Central Venous Catheter (PICC) Related Thrombosis in Cancer Patients :A Prospective Study

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 281 人开始时间: 2023年4月1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
281
试验地点
1
主要终点
The Michigan Risk Score

研究概览

简要总结

The aim of this study is to compare the accuracy and clinical predictive value of the Michigan Risk Score, Caprini Risk Assessment Model , and Maneval Scale (Chinese version)in predicting PICC-related thrombosis.

详细描述

The aim of this study is to compare the accuracy and clinical predictive value of the Michigan Risk Score, Caprini Risk Assessment Model , and Maneval Scale(Chinese version) in predicting PICC-related thrombosis.

Patients who will receive PICC placement will be evaluated by using the Michigan Risk Score, Caprini Risk Assessment Model , and Maneval Scale the day during PICC placement, 24-48h after PICC placement and every time patients receive PICC maintenance.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cancer patients
  • Older than 18 years
  • Being able to complete the questionnaire independently
  • Patients who need PICC for treatment
  • Being able to perform catheter maintenance in the hospital of admission until catheter removal
  • Patients who agree to participate and sign the consent form

排除标准

  • Patients who were or suspected to be allergic to the ingredients contained in PICC
  • PICC placed in the lower extremity

结局指标

主要结局

The Michigan Risk Score

时间窗: From date of PICC catheterization until the date of PICC removal or date of occurrence of PICC related thrombosis, whichever came first, assessed up to 12 months.

The risk score will be assessed. In this scale,risk factors associated with PICC-DVT included: history of DVT; multi-lumen PICC; active cancer; presence of another CVC when the PICC was placed; and white blood cell count greater than 12 000. The total score on the scale are 0 to 14 points, with a higher score indicates higher risk of thrombosis.

Maneval Scale

时间窗: From date of PICC catheterization until the date of PICC removal or date of occurrence of PICC related thrombosis, whichever came first, assessed up to 12 months.

The risk score will be assessed. This scale includes 45 risk factors associated with PICC thrombosis. The total score on the scale are 0 to 45 points, with a higher score indicates higher risk of thrombosis.

PICC thrombosis

时间窗: through study completion,up to 1 year

symptomatic thrombosis,diagnosed by symptoms such as pain, tenderness and swelling of the affected part and the verification of color doppler ultrasound of venous vessels

Caprini Risk Assessment Model

时间窗: From date of PICC catheterization until the date of PICC removal or date of occurrence of PICC related thrombosis, whichever came first, assessed up to 12 months.

The risk score will be assessed. This scale includes more than 40 risk factors associated with PICC thrombosis. In this scale,a higher score indicates higher risk of thrombosis.

次要结局

未报告次要终点

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeyin Hu

Infusion Therapy Specialist Nurse

Sun Yat-sen University

研究点 (1)

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