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Clinical Trials/NCT05977452
NCT05977452
Completed
Not Applicable

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

Sun Yat-sen University1 site in 1 country281 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thrombosis
Sponsor
Sun Yat-sen University
Enrollment
281
Locations
1
Primary Endpoint
The Michigan Risk Score
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
January 2, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Zeyin Hu

Infusion Therapy Specialist Nurse

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

The Michigan Risk Score

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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