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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05977452
Other study ID # SunYat-senU 7-18
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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.
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