NCT03885570

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 19, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

January 30, 2019

Last Update Submit

September 17, 2019

Conditions

Mitral Valve ReplacementTransfusion ReactionBlood Transfusion Complication

Keywords

mitral valve replacementPredictive ModelBlood TransfusionPerioperative period

Outcome Measures

Primary Outcomes (2)

  • Mortality

    The mortality during and after hospitalization

    through study completion, an average of 2 year

  • Intraoperative blood transfusion

    The amount of intraoperative blood component input

    through study completion, an average of 1 year

Study Arms (1)

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

Interventions

Mitral valve replacementPROCEDURE

Blood transfusion

Groups/Cohorts

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Lack of necessary tests and patient test information is not detailed, blood transfusion information is not detailed;
  • 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;
  • Heart surgery or emergency surgery again.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Xiangya Hospital

Changsha, Hunan, 410013, China

RECRUITING

Related 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.

    PMID: 28412317BACKGROUND

  • 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. doi: 10.1007/s11605-016-3279-8. Epub 2016 Sep 30.

    PMID: 27696209BACKGROUND

  • 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.

    PMID: 26222497BACKGROUND

  • 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.

    PMID: 24724943BACKGROUND

  • 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.

    PMID: 18194382BACKGROUND

MeSH Terms

Conditions

Transfusion Reaction

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesImmune System Diseases

Study Officials

  • Rong Gui

    The Third Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Gui, Ph.D

CONTACT

13975199279aguirong@163.com

Haiye Jiang, M.Med.

CONTACT

139748733611972692495@qq.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2019

First Posted

March 21, 2019

Study Start

September 16, 2019

Primary Completion

December 2, 2019

Study Completion

December 31, 2021

Last Updated

September 19, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)