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Blood Transfusion Management in Patients With Mitral Valve Replacement in China

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ClinicalTrials.gov Identifier: NCT03885570
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
Second Xiangya Hospital of Central South University
Chinese Academy of Medical Sciences, Fuwai Hospital
The Affiliated Hospital Of Southwest Medical University
Qilu Hospital of Shandong University
Zhejiang Provincial People's Hospital
Beijing Aerospace General Hospital
Information provided by (Responsible Party):
The Third Xiangya Hospital of Central South University

Tracking Information
First Submitted Date January 30, 2019
First Posted Date March 21, 2019
Last Update Posted Date September 19, 2019
Estimated Study Start Date September 16, 2019
Estimated Primary Completion Date December 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2019)
  • Mortality [ Time Frame: through study completion, an average of 2 year ]
    The mortality during and after hospitalization
  • Intraoperative blood transfusion [ Time Frame: through study completion, an average of 1 year ]
    The amount of intraoperative blood component input
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Blood Transfusion Management in Patients With Mitral Valve Replacement in China
Official Title Establishment of AI Prediction Model of Blood Transfusion Management in Patients With Mitral Valve Replacement
Brief Summary 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.
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
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with "mitral valve replacement" surgery who meet the standard in China, 18<Age<75.
Condition
  • Mitral Valve Replacement
  • Transfusion Reaction
  • Blood Transfusion Complication
Intervention Procedure: Mitral valve replacement
Blood transfusion
Study Groups/Cohorts 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.
Intervention: Procedure: Mitral valve replacement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 20, 2019)		 2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rong Gui, Ph.D 13975199279 aguirong@163.com
Contact: Haiye Jiang, M.Med. 13974873361 1972692495@qq.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03885570
Other Study ID Numbers ThirdXiangyaHCSUJF
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party The Third Xiangya Hospital of Central South University
Study Sponsor The Third Xiangya Hospital of Central South University
Collaborators
  • Second Xiangya Hospital of Central South University
  • Chinese Academy of Medical Sciences, Fuwai Hospital
  • The Affiliated Hospital Of Southwest Medical University
  • Qilu Hospital of Shandong University
  • Zhejiang Provincial People's Hospital
  • Beijing Aerospace General Hospital
Investigators
Principal Investigator: Rong Gui The Third Xiangya Hospital of Central South University
PRS Account The Third Xiangya Hospital of Central South University
Verification Date March 2019