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CompletedNCT05977452Updated Jul 9, 2024

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

An observational study in Thrombosis and Catheter, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-09.

Sponsored by Sun Yat-sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
281
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Thrombosis
  • Catheter

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03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 281 is above the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
281 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • patients with PICC placement

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

Interventions

  • Diagnostic testMichigan 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: through study completion,up to 1 year

  2. 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.

    Time frame: 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.

  3. 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.

    Time frame: 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.

  4. 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.

    Time frame: 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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Study locations

1 site
  • The Catheter Clinic
    Guangzhou, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05977452
Lead sponsor
Sun Yat-sen University
Responsible party
Zeyin Hu (Infusion Therapy Specialist Nurse, Sun Yat-sen University) — Principal investigator
First posted
Aug 4, 2023
Start date
Apr 1, 2023
Primary completion
Jan 2, 2024
Completion
Jan 2, 2024
Last update
Jul 9, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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