Liver Transplant; ComplicationsNCT04188717
Incidence, Risk Factors, Predictors and Survival for Neurological Complications After Liver Transplantation
An observational study of Liver Transplant; Complications and Neurologic Complication, run by Institute of Liver and Biliary Sciences, India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant; Complications, Neurologic Complication, Postoperative Complications
- How many people
- 253 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent liver transplant surgery for the specified time period were included in the study.
Who may be able to join
- patients undergoing liver transplant surgery
- 18-65 years
Who cannot join
- pregnant patients
- Acute Liver Failure, Acute on Chronic Liver Failure
About this study
Official title: 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.
- Keywords
- liver transplantation, neurological complications, postoperative complications
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological complications
type of neurological complication
Measured: 90 days
Mortality
mortality due to any cause
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start1 Jan 2010
- Primary completion31 Dec 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karthik T Ponnappan, DM, Principal investigator, ILBS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188717
- Sponsor's protocol ID
- ILBS - Liver Transplant-2
- Status last verified
- Nov 2019
- First submitted
- 28 Nov 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors, Predictors and Survival for Neurological Complications After Liver Transplantation- A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT04188717
- Acronym / sponsor ID
- ILBS - Liver Transplant-2
- Keywords
- liver transplantation, neurological complications, postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent liver transplant surgery for the specified time period were included in the study.
Key inclusion criteria (2 listed)
- patients undergoing liver transplant surgery
- 18-65 years
Key exclusion criteria (2 listed)
- pregnant patients
- Acute Liver Failure, Acute on Chronic Liver Failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurological complications
Time frame: 90 days
type of neurological complication
Mortality
Time frame: 90 days
mortality due to any cause
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karthik T Ponnappan, DM principal investigator
ILBS
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications and Neurologic Complication, run by Institute of Liver and Biliary Sciences, India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological complications (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.