NCT02548130

Brief Summary

The goal of this observational study was to evaluate the impact of the adoption of the MELD system to prioritize patients on the waiting list for OLT on survival for 1000 consecutive liver transplantations. Survival was evaluated on the waiting list, one month, and one year after the transplantation. Another goal was to look at blood losses and transfusion requirement after the adoption of the MELD score. The hypothesis was the MELD system will ameliorate the survival rate on the waiting, but the post-OLT will be worse. Blood losses and transfusions could be worse with the MELD system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 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 29, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2019

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

4 years

First QC Date

September 7, 2015

Last Update Submit

August 16, 2021

Conditions

End Stage Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Survival;

    one year

Secondary Outcomes (2)

  • Bleeding

    Per-operatively

  • transfusion of blood products

    Per0operatively

Study Arms (2)

Patients before MELD score

Recipients before the MELD score

Patients after the MELD score

Recipients after the MELD score

Other: MELD score

Interventions

MELD scoreOTHER

introduction of MELD score

Patients after the MELD score

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients for a liver transplantation

You may qualify if:

  • Patients for a liver transplantation at the investigators' institution

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Manon Choiniere, PhD

    CrCHUM

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 7, 2015

First Posted

September 14, 2015

Study Start

July 29, 2015

Primary Completion

July 21, 2019

Study Completion

July 21, 2019

Last Updated

August 20, 2021

Record last verified: 2021-08

Locations

CA(1)