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

NCT05977452 | Completed

• 1 other identifier: SunYat-senU 7-18
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombosis; Catheter

Outcome Measures

Primary Outcomes (4)

• 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

• 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.

• 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.

• 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.

Study Arms (1)

patients with PICC placement

Diagnostic Test: Michigan Risk Score, Caprini Risk Assessment Model , Maneval scale

Interventions

Michigan Risk Score, Caprini Risk Assessment Model , Maneval scale DIAGNOSTIC_TEST

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.

patients with PICC placement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

cancer patients with PICC placement in Sun Yat-sen University Cancer Center

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The Catheter Clinic

Guangzhou, China

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Infusion Therapy Specialist Nurse

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 4, 2023
• Study Start: April 1, 2023
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

CN (1)