NCT04853641

Brief Summary

Prospectively enrolled retrospective chart review and Liver Transplant database review to determine the modifiable and nonmodifiable risk factors specifically relating to Living Donor Liver Transplants. To observe the impact of age and BMI on graft outcomes and whether they impact the intraoperative management, post-operative length of stay, and complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

April 13, 2021

Last Update Submit

April 27, 2023

Conditions

Liver Transplant; ComplicationsPerioperative/Postoperative Complications

Keywords

Age Related OutcomesBMI related outcomesLiver Transplantation

Outcome Measures

Primary Outcomes (3)

  • Graft Function 30 day

    How well does the organ function

    30 day

  • Mortality

    Mortality at 1 year

    1 year

  • Graft Survival 1 year

    Survival of Organ at 1 year

    1 year

Secondary Outcomes (6)

  • Perioperative Complications

    30 day

  • Length of Stay- Total and ICU

    Up to 6 months

  • Duration of Intubation/Ventilation

    Up to 6 months

  • Postoperative Complications

    Up to 6 months

  • Blood Transfusion

    Up to 2 days

  • +1 more secondary outcomes

Study Arms (2)

Living Donor Liver Transplant Recipient

Patients who have received a living donor liver transplant.

Procedure: Living Donor

Deceased Donor Liver Transplant Recipient

Patients who have received either a Deceased by Circulatory Death or Deceased by Brain Death Liver Transplant

Procedure: Cadaveric

Interventions

CadavericPROCEDURE

Cadaveric Organ Transplant

Deceased Donor Liver Transplant Recipient
Living DonorPROCEDURE

Living Donor Organ Transplant

Living Donor Liver Transplant Recipient

Eligibility Criteria

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

Patients with end-stage liver disease, cirrhosis, or cancer requiring a liver transplant.

You may qualify if:

  • All patients who received a liver transplant at UPMC- Montefiore Hospital Age\> 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Montefiore

Pittsburgh, Pennsylvania, 15207, United States

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 21, 2021

Study Start

July 1, 2020

Primary Completion

June 30, 2022

Study Completion

November 30, 2022

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

No current plans

Locations

US(1)