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

Study 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.

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

Conditions
-----------------
Thrombosis, Catheter

Intervention / Treatment
-----------------
* Diagnostic Test: Michigan Risk Score, Caprini Risk Assessment Model , Maneval scale


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with PICC placement<br> | Diagnostic Test: Michigan Risk Score, Caprini Risk Assessment Model , Maneval scale<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |