NCT05895669

Brief Summary

All patients with orthotopic liver transplantation who are evaluated and followed at each participating centers will be recorded in this study. Within this register a characterization of patients and therapy will be done. Prognostic factors of defined clinical relevant endpoints will be evaluated.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

May 2, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2024

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

May 26, 2023

Last Update Submit

June 6, 2023

Conditions

Liver Transplant; ComplicationsCardiovascular ComplicationCardiovascular; AttackCardiovascular StrokeDeath

Outcome Measures

Primary Outcomes (2)

  • Cardiovascular death

    death due to cardiac causes (myocardial infraction and/or stroke)

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

  • cardiovascular complication

    fatal and non fatal myocardial infraction and/or stroke

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with ortothopic liver transplantation

You may qualify if:

  • All patients with ortothopic liver transplantation and at least 2 year follow-up at the referral center

You may not qualify if:

  • Missing Informed Consent Form
  • Missing Contact Informations for Follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gragnano Hospital

Gragnano, SA, 80054, Italy

RECRUITING

University of Campania Luigi Vanvitelli

Napoli, 80138, Italy

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionDeath

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Alfredo Caturano, MD

CONTACT

+393338616985alfredo.caturano@unicampania.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 8, 2023

Study Start

May 2, 2023

Primary Completion

May 2, 2024

Study Completion

May 2, 2024

Last Updated

June 8, 2023

Record last verified: 2023-06

Locations

IT(2)