NCT04188717

Brief Summary

Liver transplantation is the definitive treatment in patients with chronic liver disease. Neurological complications (NC) occur commonly after liver transplantation. The investigators aim to evaluate the incidence, risk factors and predictors of neurological complications in both living donor and deceased donor transplantation done in the hospital. Between January 2011 to December 2016, 253 liver transplant recipients were recruited for this study. The investigators recorded the incidence of neurological complications, their median time of onset, their relationship with etiology of chronic liver disease, and the risk factors for the complications. The investigators also studied the relationship of neurological complications with duration of hospital and ICU stay, and survival. Using multivariate forward regression analysis , the investigators developed a scoring system for prediction of neurological complications in liver transplantation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
253

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

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

January 1, 2010

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
Last Updated

December 10, 2019

Status Verified

November 1, 2019

Enrollment Period

7 years

First QC Date

November 28, 2019

Last Update Submit

December 7, 2019

Conditions

Keywords

liver transplantationneurological complicationspostoperative complications

Outcome Measures

Primary Outcomes (2)

  • Neurological complications

    type of neurological complication

    90 days

  • Mortality

    mortality due to any cause

    90 days

Eligibility Criteria

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

All patients who underwent liver transplant surgery for the specified time period were included in the study.

You may qualify if:

  • patients undergoing liver transplant surgery
  • years

You may not qualify if:

  • pregnant patients
  • Acute Liver Failure, Acute on Chronic Liver Failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karthik T Ponnappan, DM

    ILBS

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 28, 2019

First Posted

December 6, 2019

Study Start

January 1, 2010

Primary Completion

December 31, 2016

Study Completion

January 1, 2017

Last Updated

December 10, 2019

Record last verified: 2019-11