NCT04107883

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
4 years until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

September 20, 2019

Last Update Submit

November 21, 2023

Conditions

End Stage Liver DIseaseLiver Transplantation

Keywords

endothelialplasma

Outcome Measures

Primary Outcomes (1)

  • endothelial glycocalyx layer shedding markers

    plasma concentration of endothelial glycocalyx layer shedding markers

    24 hours

Secondary Outcomes (1)

  • inflammatory cytokines

    24 hours

Study Arms (2)

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 plasmaDiagnostic Test: blood sample

Interventions

fresh frozen plasmaBIOLOGICAL

perform plasma transfusion in different phases during perioperation

anhapetic group
blood sampleDIAGNOSTIC_TEST

get blood samples at several specific points in time during perioperation

anhapetic groupcontrol group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Medical University Affiliated Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

End Stage Liver Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Anshi Wu

    Capital Medical University Affiliated Beijing Chaoyang Hospital

    STUDY CHAIR

Central Study Contacts

Xun Liu

CONTACT

+86 1346650572513466505725@163.com

Anshi Wu

CONTACT

+86 010 85231330wuanshi@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2019

First Posted

September 27, 2019

Study Start

October 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)