NCT06534840

Brief Summary

The main objective of this study is to develop a machine learning model that predicts moderate-severe prediction model of pulmonary complications in liver transplantation patients within 14 postoperative day using a real-world, local preoperative and intraoperative electronic health records, not administrative codes.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

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 Start

First participant enrolled

July 15, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 30, 2024

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prediction of postoperative moderate-to-severe pulmonary complications

    IA total of 72 variables are expected to be included, using 6 types of machine learning methods, including decision tree (DT), logistic regression (LR), random forest (, RF), support vector machine (SVM), extreme gradient lift (XGBoost), and gradient lift decision tree (GBDT) to build a moderate postoperative prediction model

    August 2024-December 2024

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent liver transplantation from January 1,2016to December 31,2019 were admitted to the study.

You may qualify if:

  • Adult patients (age ≥ 18 years)
  • Undergoing liver transplantation

You may not qualify if:

  • Re-transplantation
  • Multi-organ transplants
  • Intra-operative deaths
  • severe encephalopathy (West Haven criteria III or IV)
  • Incomplete clinical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Central Study Contacts

Chun ling Jiang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

July 15, 2024

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

August 2, 2024

Record last verified: 2024-07

Locations