To Establish a Blood Transfusion Prediction Model for Liv... | NCT03814772

Studies
To Establish a Blood Transfusion Prediction Model for Liver Transplantation Patients Based on PBM

NCT03814772

Sponsor

The Third Xiangya Hospital of Central South University

Status

Unknown status

Last Update Posted

Feb 21, 2019Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Blood Transfusion Complication

Interventions

Liver transplant

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2019Estimated

Primary Completion Date

Dec 1, 2019Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Jan 20, 2019

First Submission Date that Met QC Criteria

Jan 20, 2019

First Posted Date

Jan 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2019

Last Update Posted Date

Feb 21, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

The Third Xiangya Hospital of Central South UniversityOTHER

Collaborators

Name	Class
Second Xiangya Hospital of Central South University	OTHER
RenJi Hospital	OTHER
Qilu Hospital of Shandong University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liver transplant		18 years to 65 48h preoperative biochemical indicators, blood general indicators, coagulation test complete	Procedure: Liver transplant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liver transplant	Procedure	blood transfusion	Liver transplant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
one year mortality	All-cause mortality	2019-2021

Secondary Outcomes

Measure	Description	Time Frame
Intraoperative blood transfusion	Intraoperative blood component input	2019-2021

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Allogeneic liver transplantation surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rong Gui, doctor	Contact	+8615200828442		aguirong@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the Third Xiangya Hospital of Central South University	Recruiting	Changsha	Hunan	410006	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065227	Transfusion Reaction

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016031	Liver Transplantation

Ancestor Terms

ID	Term
D016378	Tissue Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided