Blood Transfusion Management in Patients With Mitral Valve Replacement in China

Blood Transfusion Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03885570
• Other study ID #: ThirdXiangyaHCSUJF
• Status: Recruiting
• Start date: September 16, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2019
• Source: The Third Xiangya Hospital of Central South University
• Contact: Rong Gui, Ph.D
• Phone: 13975199279
• Email: aguirong[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Transfusion Complication
• Mitral Valve Replacement
• Transfusion Reaction

Intervention

Procedure:
• Mitral valve replacement
Blood transfusion

Locations

Country	Name	City	State
China	Third Xiangya Hospital	Changsha	Hunan

Sponsors (7)

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

Country where clinical trial is conducted

China, 

References & Publications (5)

de Schipper LJ, Baharoglu MI, Roos YBWEM, de Beer F. Medical Treatment for Spontaneous Anticoagulation-Related Intracerebral Hemorrhage in the Netherlands. J Stroke Cerebrovasc Dis. 2017 Jul;26(7):1427-1432. doi: 10.1016/j.jstrokecerebrovasdis.2017.03.019. Epub 2017 Apr 12. — View Citation

Hogervorst E, Rosseel P, van der Bom J, Bentala M, Brand A, van der Meer N, van de Watering L. Tolerance of intraoperative hemoglobin decrease during cardiac surgery. Transfusion. 2014 Oct;54(10 Pt 2):2696-704. doi: 10.1111/trf.12654. Epub 2014 Apr 14. — View Citation

Karkouti K, Wijeysundera DN, Yau TM, McCluskey SA, van Rensburg A, Beattie WS. The influence of baseline hemoglobin concentration on tolerance of anemia in cardiac surgery. Transfusion. 2008 Apr;48(4):666-72. doi: 10.1111/j.1537-2995.2007.01590.x. Epub 2008 Jan 10. — View Citation

Spolverato G, Bagante F, Weiss M, He J, Wolfgang CL, Johnston F, Makary MA, Yang W, Frank SM, Pawlik TM. Impact of Delta Hemoglobin on Provider Transfusion Practices and Post-operative Morbidity Among Patients Undergoing Liver and Pancreatic Surgery. J Gastrointest Surg. 2016 Dec;20(12):2010-2020. Epub 2016 Sep 30. — View Citation

Spolverato G, Kim Y, Ejaz A, Frank SM, Pawlik TM. Effect of Relative Decrease in Blood Hemoglobin Concentrations on Postoperative Morbidity in Patients Who Undergo Major Gastrointestinal Surgery. JAMA Surg. 2015 Oct;150(10):949-56. doi: 10.1001/jamasurg.2015.1704. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	The mortality during and after hospitalization	through study completion, an average of 2 year
Primary	Intraoperative blood transfusion	The amount of intraoperative blood component input	through study completion, an average of 1 year