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

Completed

• Conditions: Catheter; Thrombosis
• Interventions: Diagnostic Test: Michigan Risk Score, Caprini Risk Assessment Model , Maneval scale

• Registration Number: NCT05977452
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-04
• Primary Completion: 2024-01-02
• Study Completion: 2024-01-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with PICC placement	Michigan Risk Score, Caprini Risk Assessment Model , Maneval scale	-

Primary Outcome Measures

Name	Time	Method
The Michigan Risk Score	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	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	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	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.

Trial Locations

Locations (1)

The Catheter Clinic; 🇨🇳 Guangzhou, China