Selection Protocol for Liver Transplantation in Patients... | NCT06382740

Studies
Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years

NCT06382740

Sponsor

Azienda Ospedaliera di Padova

Status

Unknown status

Last Update Posted

Apr 24, 2024Actual

Enrollment

18Estimated

Phase

Not provided

Conditions

End Stage Liver DIsease
Liver Transplantation
Old Age

Interventions

Liver transplantation

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Oct 1, 2025Estimated

Completion Date

Oct 1, 2025Estimated

First Submitted Date

Mar 9, 2023

First Submission Date that Met QC Criteria

Apr 22, 2024

First Posted Date

Apr 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2024

Last Update Posted Date

Apr 24, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Umberto Cillo, Director, Azienda Ospedaliera di PadovaPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera di PadovaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process.

This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Name	Type	Description	Arm Group Labels	Other Names
Liver transplantation	Procedure	Liver transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1 year patient survival	Overall patients survival at 12 months from liver transplantation	12 months

Secondary Outcomes

Measure	Description	Time Frame
1 year graft survival	Overall graft survival at 12 months from liver transplantation	12 months
3 months mortality and morbidity	Mortality and morbidity rates at 3 months from liver transplantation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >70 years and ≤ 75 years
Liver transplant from cadaveric donor
First liver transplant
End stage liver disease or liver tumor

Exclusion Criteria:

Age ≤ 70 years
Living donor liver transplant
Previous liver transplant
Liver transplant for acute liver failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

71 Years

Maximum Age

75 Years

Standard Ages

Older Adult

Study Population

Consecutive candidates for liver transplant with age >70 and ≤ 75 years

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Umberto Cillo, Prof	Contact	049.8212211-1897		cillo@unipd.it
Alessandro Vitale, Prof	Contact			alessandro.vitale@unipd.it

Overall Officials

Name	Affiliation	Role
Umberto Cillo, Prof	Azienda Ospedaliera di Padova	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova	Recruiting	Padova		35128	Italy

Condition Browse Module

MeSH Terms

ID	Term
D058625	End Stage Liver Disease

Ancestor Terms

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016031	Liver Transplantation

Ancestor Terms

ID	Term
D016378	Tissue Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided