Effect of Transfusion of Plasma on Endothelial During Liv... | NCT04107883

Studies
Effect of Transfusion of Plasma on Endothelial During Liver Transplantation

NCT04107883

Sponsor

Beijing Chao Yang Hospital

Status

Unknown status

Last Update Posted

Nov 24, 2023Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

End Stage Liver DIsease
Liver Transplantation

Interventions

fresh frozen plasma
blood sample

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

Nov 2023

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

Oct 1, 2023Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Sep 20, 2019

First Submission Date that Met QC Criteria

Sep 26, 2019

First Posted Date

Sep 27, 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

Nov 21, 2023

Last Update Posted Date

Nov 24, 2023Actual

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

To study the effects of plasma transfusionon during liver transplantation on endothelial condition and short-term outcome in patients with end-stage liver disease.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	Experimental	perform artificial colloidal solution transfusion during anhapetic phase.	Diagnostic Test: blood sample
anhapetic group	Experimental	Perform plasma transfusion during anhapetic phase.	Biological: fresh frozen plasma Diagnostic Test: blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fresh frozen plasma	Biological	perform plasma transfusion in different phases during perioperation	anhapetic group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
endothelial glycocalyx layer shedding markers	plasma concentration of endothelial glycocalyx layer shedding markers	24 hours

Secondary Outcomes

Measure	Description	Time Frame
inflammatory cytokines	levels of inflammatory cytokines	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Child A/B cirrhosis
patients who undergo the first OLT
Informed and consented
complete follow-up
cooperate with treatment

Exclusion Criteria:

re-transplant
combined liver and other organ transplantation
BMI≥30Kg/m2
patients with hypertension, diabetes, coronary heart disease, chronic renal insufficiency, preoperative pulmonary infection, pleural effusion
acute liver failure

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xun Liu	Contact	+86 13466505725		13466505725@163.com
Anshi Wu	Contact	+86 010 85231330		wuanshi@hotmail.com

Overall Officials

Name	Affiliation	Role
Anshi Wu	Capital Medical University Affiliated Beijing Chaoyang Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Capital Medical University Affiliated Beijing Chaoyang Hospital	Recruiting	Beijing	Beijing Municipality	100020	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058625	End Stage Liver Disease

Ancestor Terms

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided