Mitral Valve ReplacementNCT03885570
Blood Transfusion Management in Patients With Mitral Valve Replacement in China
An observational study of Mitral Valve Replacement and Transfusion Reaction, run by The Third Xiangya Hospital of Central South University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mitral Valve Replacement, Transfusion Reaction, Blood Transfusion Complication
- What is being tested?
- Mitral valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with "mitral valve replacement" surgery who meet the standard in China, 18<Age<75.
Who may be able to join
- Patients undergoing "mitral valve replacement" surgery;
- Age 18-75 years old;
- 48h biochemical indicators before surgery, blood general indicators, coagulation indicators are complete.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third Xiangya Hospital
Changsha, Hunan, 410013
Rong Gui, Ph.D, 13975199279, aguirong@163.com
Haiye Jiang, M.Med., 13974873361, 1972692495@qq.com
About this study
Official title: 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.
Read the detailed description
- 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.
- 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.
- 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.
- Being tested
- Mitral valve replacement
- Keywords
- mitral valve replacement, Predictive Model, Blood Transfusion, Perioperative period
- Medical subject headings
- Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve replacementProcedure or surgery
Blood transfusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Mitral valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The mortality during and after hospitalization
Measured: through study completion, an average of 2 year
Intraoperative blood transfusion
The amount of intraoperative blood component input
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start16 Sep 2019 (estimated)
- Primary completion2 Dec 2019 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve ReplacementStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Rong Gui, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885570
- Sponsor's protocol ID
- ThirdXiangyaHCSUJF
- Status last verified
- Mar 2019
- First submitted
- 30 Jan 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28412317Spolverato 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.
PubMed 27696209Spolverato 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.
PubMed 26222497Hogervorst 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.
PubMed 24724943Karkouti 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.
PubMed 18194382
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of AI Prediction Model of Blood Transfusion Management in Patients With Mitral Valve Replacement
- ClinicalTrials.gov ID
- NCT03885570
- Acronym / sponsor ID
- ThirdXiangyaHCSUJF
- Keywords
- mitral valve replacement, Predictive Model, Blood Transfusion, Perioperative period
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- 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
- Study start
- 16 Sep 2019 (estimated)
- Primary completion
- 2 Dec 2019 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Groups/Cohorts | – | Procedure: Mitral valve replacement1) Patients undergoing "mitral valve replacement" surgery;2) Age 18-75 years old;3) 48h preoperative biochemical indicators, blood general indicators, coagulation indicators are complete. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with "mitral valve replacement" surgery who meet the standard in China, 18<Age<75.
Key inclusion criteria (3 listed)
- Patients undergoing "mitral valve replacement" surgery;
- Age 18-75 years old;
- 48h biochemical indicators before surgery, blood general indicators, coagulation indicators are complete.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitral valve replacementBlood transfusion | Procedure or surgery | Groups/Cohorts |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Background: PubMed 28412317de 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.
- Background: PubMed 27696209Spolverato 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.
- Background: PubMed 26222497Spolverato 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.
- Background: PubMed 24724943Hogervorst 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.
- Background: PubMed 18194382Karkouti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong Gui principal investigator
The Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Replacement and Transfusion Reaction, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rong Gui, Ph.D (13975199279, aguirong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: through study completion, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03885570, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.