Effect of Transfusion of Plasma on Endothelial During Liver Transplantation

January 22, 2020 updated by: Xun Liu, Beijing Chao Yang Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

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

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Capital Medical University Affiliated Beijing Chaoyang Hospital
        • Contact:
        • Contact:

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: control group
Do not perform plasma transfusion during operation.
Diagnostic test: blood sample
get blood samples at several specific points in time during perioperation
Experimental: anhapetic group
Perform plasma transfusion during anhapetic phase.
Diagnostic test: blood sample
get blood samples at several specific points in time during perioperation
Biological: fresh frozen plasma
perform plasma transfusion in different phases during perioperation
Experimental: neohepatic group
Perform plasma transfusion during neohepatic phase.
Diagnostic test: blood sample
get blood samples at several specific points in time during perioperation
Biological: fresh frozen plasma
perform plasma transfusion in different phases during perioperation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
syndecan-1
Time Frame: 5 days
plasma concentration of syndecan-1
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival
Time Frame: 30 days
survival during 30 days after operation
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Investigators

  • Study Chair: Anshi Wu, Capital Medical University Affiliated Beijing Chaoyang Hospital

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 (Actual)

January 1, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LX-2019-LT-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Liver Transplantation

Clinical Trials on blood sample

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe