NCT06859242

Brief Summary

This study aims to develop a risk prediction model for iodine contrast agent extravasation from peripheral veins and to implement this model clinically to establish a risk control management system for iodine contrast agent extravasation.A case-control study design was employed to collect data for model development. The case group comprised patients who experienced iodine contrast agent extravasation during enhanced CT examinations, while the control group included patients who underwent similar examinations without extravasation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Jan 2025Nov 2026

Study Start

First participant enrolled

January 25, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 24, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

February 24, 2025

Last Update Submit

February 27, 2025

Conditions

Keywords

Extravasation of Contrast MediaPredictive ModelsMachineRisk Management

Outcome Measures

Primary Outcomes (2)

  • accuracy of prediction model

    the ratio of correct predictions to the total number of model predictions(%)

    through study completion, an average of 1 year

  • the incidence of peripheral venous iodine contrast agent extravasation

    the number of iodine contrast agent extravasation times divided by the total number of enhanced CT examinations during the same period(%)

    One year before and after the prediction model is put into use.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received enhanced CT scans via peripheral venous indwelling needle.

You may qualify if:

  • Volunteer to participate in this study.
  • Without contraindications such as iodine contrast allergy or hyperthyroidism. -

You may not qualify if:

  • There are communication barriers between researchers and patients.
  • Due to critical condition or unstable vital signs, patients should be transferred to relevant clinical departments for treatment or observation immediately after examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TongjiHospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Extravasation of Diagnostic and Therapeutic Materials

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Wenyan Zhang, Master

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenyan Zhang, Master

CONTACT

Qin Li

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 24, 2025

First Posted

March 5, 2025

Study Start

January 25, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

March 5, 2025

Record last verified: 2025-02

Locations