- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03814772
To Establish a Blood Transfusion Prediction Model for Liver Transplantation Patients Based on PBM
February 20, 2019 updated by: The Third Xiangya Hospital of Central South University
To Establish a Prediction Model of Massive Blood Transfusion for Liver Transplantation Patients Based on Patient Blood Management
Based on the principle of patient blood management, this study aims to reduce the risk of blood transfusion in allogeneic liver transplantation patients, to ensure the safety of blood transfusion, and to provide new methods and basis for restrictive blood transfusion.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
- Preoperative variables and statistical analysis of a large number of intraoperative blood transfusions in allogeneic liver transplantation patients were performed to screen preoperative variables.
- Models were established by machine learning algorithms to predict a large number of blood transfusions during surgery, providing a reference for preoperative blood preparation and postoperative outcome.
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 Contact
- Name: Rong Gui, doctor
- Phone Number: +8615200828442
- Email: aguirong@163.com
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410006
- Recruiting
- The Third Xiangya Hospital of Central South University
-
Contact:
- Rong Gui
- Phone Number: +8615200828442
- Email: aguirong@163.com
-
-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Allogeneic liver transplantation surgery
Description
Inclusion Criteria:
- 48h preoperative biochemical indicators, blood general indicators, coagulation test complete
Exclusion Criteria:
- 1. Inspection information is not detailed 2. Blood transfusion information is not detailed 3.Postoperative medical record information is not detailed
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Liver transplant
|
blood transfusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
one year mortality
Time Frame: 2019-2021
|
All-cause mortality
|
2019-2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraoperative blood transfusion
Time Frame: 2019-2021
|
Intraoperative blood component input
|
2019-2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
March 20, 2019
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
January 20, 2019
First Submitted That Met QC Criteria
January 20, 2019
First Posted (Actual)
January 24, 2019
Study Record Updates
Last Update Posted (Actual)
February 21, 2019
Last Update Submitted That Met QC Criteria
February 20, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ThirdXiangyaLTP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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