CClinicalTrials.gg
Status unknownNCT04663477Updated Dec 11, 2020

Development and Validation of the Patient-completed Caprini Risk Score

An observational study in Venous Thromboembolism, sponsored by China-Japan Friendship Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2020-12-11.

Sponsored by China-Japan Friendship Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,017
Sex
All
01

Study summary

The investigators aimed to test the reliability and validity of the Chinese version of patient-completed CRS in hospitalized patients and to evaluate whether this form can be widely used in clinical practice instead of only health care workers' evaluation.

02

Conditions studied

  • Venous Thromboembolism

Keywords

  • VTE risk
  • Caprini
  • Patient-complete
  • Validation
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's planned enrollment of 1,017 is above the median of 500 across 344 observational studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The investigators will recruite nearly 500 inpatients from the surgical unit and nearly 500 inpatients from the medical unit between January 1 and December 31, 2019

Inclusion criteria

  • patients older than 18 years
  • patients with first admission to the medical and surgical units within 24 hours
  • willingness to participate in the study

Exclusion criteria

Exclusion Criteria:

  • patients with a diagnosis of PTE or DVT on admission
  • patients with cognitive impairment
  • inability to read or write
  • patients with mental diseases
  • patients with visual impairment
  • refusal to cooperate
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,017 participants (estimated)
Patient registry
No

Groups and cohorts

  • Trained nurse-completed CRS

    Diagnostic Test: patient-completed Caprini Risk Score

  • Patient-completed CRS

    Diagnostic Test: patient-completed Caprini Risk Score

Interventions

  • Diagnostic testpatient-completed Caprini Risk Score

    The participants will be asked to complete patient-completed Caprini Risk Score

06

What researchers measure

Primary outcomes

  1. Question-to-question agreement between patient-completed and nurse-completed CRS

    The investigators will use kappa value to compare the question-to-question agreement level between nurse and patient-completed Caprini Risk Score

    Time frame: one year

Secondary outcomes

  1. Correlation and difference between the scores calculated by patient-completed and nurse-completed CRS

    The Spearman correlation coefficient was used to measure the correlation and difference between patient-completed and nurse-completed CRS.

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • China-Japan Frendship hospital
    Beijing, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04663477
Lead sponsor
China-Japan Friendship Hospital
Responsible party
Zhenguo Zhai,MD,PhD (Deputy Director of the Second Department of Respiratory and Critical Care Medicine in China-Japan Friendship Hospital, China-Japan Friendship Hospital) — Principal investigator
First posted
Dec 11, 2020
Start date
Jan 1, 2019
Primary completion
Oct 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Dec 11, 2020

Study contacts

Zhenguo Zhai, MD.PhD
Contact
zhaizhenguo2011@126.com
(+86)010-84201000
Zhu Zhang, MD.PHD
Contact
zhuperfectlife@126.com
(+86)010-84206408

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion