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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05977452
Collaborator
(none)
281
1
9
31.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Michigan Risk Score, Caprini Risk Assessment Model , Maneval scale

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
281 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Risk Assessment Scale for Peripherally Inserted Central Venous Catheter (PICC) Related Thrombosis in Cancer Patients :A Prospective Study
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
patients with PICC placement

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 80 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Catheter Clinic Guangzhou China

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeyin Hu, Infusion Therapy Specialist Nurse, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05977452
Other Study ID Numbers:
  • SunYat-senU 7-18
First Posted:
Aug 4, 2023
Last Update Posted:
Aug 4, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2023