- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04188717
Incidence, Risk Factors, Predictors and Survival for Neurological Complications After Liver Transplantation
December 7, 2019 updated by: Institute of Liver and Biliary Sciences, India
Incidence, Risk Factors, Predictors and Survival for Neurological Complications After Liver Transplantation- A Retrospective Analysis
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
253
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients who underwent liver transplant surgery for the specified time period were included in the study.
Description
Inclusion Criteria:
- patients undergoing liver transplant surgery
- 18-65 years
Exclusion Criteria:
- pregnant patients
- Acute Liver Failure, Acute on Chronic Liver Failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurological complications
Time Frame: 90 days
|
type of neurological complication
|
90 days
|
Mortality
Time Frame: 90 days
|
mortality due to any cause
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Karthik T Ponnappan, DM, ILBS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2010
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
November 28, 2019
First Submitted That Met QC Criteria
December 5, 2019
First Posted (Actual)
December 6, 2019
Study Record Updates
Last Update Posted (Actual)
December 10, 2019
Last Update Submitted That Met QC Criteria
December 7, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILBS - Liver Transplant-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Complications
-
Marmara UniversityHacettepe University; Cukurova University; Gazi University; Baskent University; Istanbul... and other collaboratorsNot yet recruitingComplications, PostoperativeTurkey
-
Syed HusainRecruitingComplications, PostoperativeUnited States
-
University of PittsburghCompletedLiver Transplant; Complications | Perioperative/Postoperative ComplicationsUnited States
-
Vastra Gotaland RegionRecruitingSurgery | Lung Infection | Complications, PostoperativeSweden
-
Washington University School of MedicineNational Institute of Nursing Research (NINR)CompletedSurgery | Surgery--Complications | Perioperative/Postoperative ComplicationsUnited States
-
Wake Forest University Health SciencesTerminatedPerioperative/Postoperative ComplicationsUnited States
-
Technical University of MunichHealth Information Management, BelgiumActive, not recruitingPerioperative/Postoperative Complications
-
Atatürk Chest Diseases and Chest Surgery Training...CompletedPerioperative/Postoperative ComplicationsTurkey
-
Namigar TurgutCompletedPerioperative/Postoperative ComplicationsTurkey
-
TC Erciyes UniversityCompletedPerioperative/Postoperative ComplicationsTurkey