Blood Transfusion Management in Patients With Mitral Valve Replacement in China

September 17, 2019 updated by: The Third Xiangya Hospital of Central South University

Establishment of AI Prediction Model of Blood Transfusion Management in Patients With Mitral Valve Replacement

The evaluation uses ΔHb as an independent factor combined with artificial intelligence (AI) to predict its impact on the prognosis and blood transfusion of patients undergoing cardiac surgery, thereby guiding perioperative clinical blood use and improving patient prognosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Select 8 hospitals to form a multi-center team, and enter the keyword "mitral valve replacement" in the case system of 8 hospitals to collect information on 2000 heart surgery patients.
  2. Mainly collect information on preoperative, intraoperative and postoperative test indexes (blood routine, liver and kidney function, coagulation function, blood gas), cardiac color Doppler, blood transfusion and prognosis of patients undergoing cardiac surgery, using statistical methods for analysis. Identify key observations.
  3. Gradually incorporate and exclude data, and use statistical methods to conduct preliminary analysis on the collected data.

The AI prediction model was established by machine learning algorithm to predict intraoperative blood transfusion, verify the specificity and sensitivity of the blood transfusion prediction model, and scientifically guide clinical blood use.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Third Xiangya Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with "mitral valve replacement" surgery who meet the standard in China, 18<Age<75.

Description

Inclusion Criteria:

  1. Patients undergoing "mitral valve replacement" surgery;
  2. Age 18-75 years old;
  3. 48h biochemical indicators before surgery, blood general indicators, coagulation indicators are complete.

Exclusion Criteria:

  1. Lack of necessary tests and patient test information is not detailed, blood transfusion information is not detailed;
  2. The blood transfusion information is not detailed in the same period as other cardiac operations (such as aortic valve surgery, coronary artery bypass grafting, etc.), but the tricuspid valvuloplasty is not ruled out at the same time;
  3. Heart surgery or emergency surgery again.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Groups/Cohorts
1) Patients undergoing "mitral valve replacement" surgery;2) Age 18-75 years old;3) 48h preoperative biochemical indicators, blood general indicators, coagulation indicators are complete.
Procedure: Mitral valve replacement
Blood transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: through study completion, an average of 2 year
The mortality during and after hospitalization
through study completion, an average of 2 year
Intraoperative blood transfusion
Time Frame: through study completion, an average of 1 year
The amount of intraoperative blood component input
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Xiangya Hospital of Central South University

Collaborators

Qilu Hospital of Shandong University
Chinese Academy of Medical Sciences, Fuwai Hospital
Zhejiang Provincial People's Hospital
Second Xiangya Hospital of Central South University
The Affiliated Hospital Of Southwest Medical University
Beijing Aerospace General Hospital

Investigators

  • Principal Investigator: Rong Gui, The Third Xiangya Hospital of Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 16, 2019

Primary Completion (Anticipated)

December 2, 2019

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ThirdXiangyaHCSUJF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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