NCT04327427

Brief Summary

In the experimental setting inhibition of platelet activation was able to reduce immune-mediated necroinflammatory liver disease and consecutively hepatocellular carcinoma development. Therefore, antiplatelet therapy may not only have a preventive effect on hepatic artery patency but also on tumor recurrence. So far and to the best of our knowledge, no study investigated the effect of antiplatelet therapy on hepatic arterial patency, tumor recurrence and graft survival after primary liver transplantation.

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
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 17, 2020

Last Update Submit

March 26, 2020

Conditions

Keywords

liver transplantationaspirintumor recurrenceHCCgraft survival

Outcome Measures

Primary Outcomes (1)

  • Aspirin and arterial patency

    We will look, if antiplatelet therapy with Aspirin has a protective effect on arterial patency after primary liver transplantation by looking at postoperative lab values and imaging, if they were perfromed.

    2 years

Secondary Outcomes (3)

  • Aspirin and cellular rejection

    2 years

  • Aspirin and tumor recurrence

    2 years

  • Aspirin and graft survival

    2 years

Interventions

AspirinOTHER

Outcome Analysis of Aspirin in liver transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This multicentrecohort study will include several high-volume centresworldwide. Each participating centrerequires a prospective database from that data can be extracted. All consecutive cases of deceased donor liver transplantation requiring from 1stofJanuary 2013until 31stof December 2015are included allowing a minimum follow-up time of 24months.

You may qualify if:

  • Adult Liver transplantation(age ≥18 years)
  • Deceased donor after brain death (DBD) or deceased donor after circulatory death (DCD)
  • Primary liver transplantation, whole graft
  • Arterial anastomosis: end-to-end, back table reconstruction

You may not qualify if:

  • Split liver and living donor liver transplantation
  • Paediatric liver transplantation (recipient age \<18 years)
  • Arterial conduits
  • Multivisceral transplantations
  • Retransplantations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Visceral and Transplantation Surgery

Zurich, CH/Zürich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Recurrence

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Christian E Oberkofler, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian E Oberkofler, MD

CONTACT

Henrik Petrowsky, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 31, 2020

Study Start

October 1, 2019

Primary Completion

October 1, 2020

Study Completion

May 31, 2021

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations