search
Back to results

Effect of Transfusion of Plasma on Endothelial During Liver Transplantation

Primary Purpose

End Stage Liver DIsease, Liver Transplantation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
fresh frozen plasma
blood sample
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Liver DIsease focused on measuring endothelial, plasma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Child B/C cirrhosis
  • patients who undergo the first OLT

Exclusion Criteria:

  • re-transplant
  • combined liver-kidney transplantation
  • pregnancy

Sites / Locations

  • Capital Medical University Affiliated Beijing Chaoyang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

control group

anhapetic group

neohepatic group

Arm Description

Do not perform plasma transfusion during operation.

Perform plasma transfusion during anhapetic phase.

Perform plasma transfusion during neohepatic phase.

Outcomes

Primary Outcome Measures

syndecan-1
plasma concentration of syndecan-1

Secondary Outcome Measures

survival
survival during 30 days after operation

Full Information

First Posted
September 20, 2019
Last Updated
January 22, 2020
Sponsor
Beijing Chao Yang Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04107883
Brief Title
Effect of Transfusion of Plasma on Endothelial During Liver Transplantation
Official Title
Comparison of the Effect of Different Strategies of Plasma Management During Orthotopic Liver Transplantation on Endothelial Condition and Short-term Outcome in Patients With End-Stage Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver DIsease, Liver Transplantation
Keywords
endothelial, plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Experimental
Arm Description
Do not perform plasma transfusion during operation.
Arm Title
anhapetic group
Arm Type
Experimental
Arm Description
Perform plasma transfusion during anhapetic phase.
Arm Title
neohepatic group
Arm Type
Experimental
Arm Description
Perform plasma transfusion during neohepatic phase.
Intervention Type
Biological
Intervention Name(s)
fresh frozen plasma
Intervention Description
perform plasma transfusion in different phases during perioperation
Intervention Type
Diagnostic Test
Intervention Name(s)
blood sample
Intervention Description
get blood samples at several specific points in time during perioperation
Primary Outcome Measure Information:
Title
syndecan-1
Description
plasma concentration of syndecan-1
Time Frame
5 days
Secondary Outcome Measure Information:
Title
survival
Description
survival during 30 days after operation
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Child B/C cirrhosis patients who undergo the first OLT Exclusion Criteria: re-transplant combined liver-kidney transplantation pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xun Liu
Phone
+86 13466505725
Email
13466505725@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anshi Wu
Phone
+86 010 85231330
Email
wuanshi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anshi Wu
Organizational Affiliation
Capital Medical University Affiliated Beijing Chaoyang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Capital Medical University Affiliated Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Xun
Phone
13466505725
Ext
+86
Email
13466505725@163.com
First Name & Middle Initial & Last Name & Degree
Wu A Shi
Phone
85231330
Ext
+86 010
Email
wuanshi@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Transfusion of Plasma on Endothelial During Liver Transplantation

We'll reach out to this number within 24 hrs