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

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05977452
• Other study ID #: SunYat-senU 7-18
• Status: Completed
• Start date: April 1, 2023
• Est. completion date: January 2, 2024

Study information

• Verified date: April 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: January 2, 2024
• Est. primary completion date: January 2, 2024
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter
• Thrombosis

Intervention

Diagnostic Test:
• Michigan Risk Score, Caprini Risk Assessment Model , Maneval scale
Patients with PICC placement will be assessed by the Michigan Risk Score, Caprini Risk Assessment Model , Maneval scale(Chinese version) to predict the risk of PICC-related thrombosis. The time of evaluation are the day during PICC placement, 24-48h after PICC placement, and every time when patients receive PICC maintenance.

Locations

Country	Name	City	State
China	The Catheter Clinic	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PICC thrombosis	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	through study completion,up to 1 year
Primary	The Michigan Risk Score	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.	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.
Primary	Maneval Scale	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.	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.
Primary	Caprini Risk Assessment Model	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.	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.