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Liver Transplant Does it Affect the Brain

Primary Purpose

Brain Damage, Postoperative Cognitive Dysfunction, Neuron Specific Enolase

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Damage focused on measuring Liver transplantation, Neuronal damage, Brain, Biochemical marker, Postoperative Cognitive Dysfunction

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Score of 23 or above on the Mini Mental Test (MMT) conducted in the preparation room prior to the operation,
  • No gastrointestinal bleeding in the last 1 month
  • No history of neuroactive drug use
  • Consented for the study.

Exclusion Criteria:

  • Hepatic encephalopathy,
  • Neurological disorder
  • Psychiatric disorder,

Sites / Locations

  • Ege University Faculty of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Observation

Arm Description

preoperative and postoperative cognitive functions of 33 patients undergoing liver transplantation (LTx) were measured using the Mini Mental Test (MMT) whereas simultaneous neuronal damage was evaluated through the measurement of S-100 beta (S100β), Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP) levels.

Outcomes

Primary Outcome Measures

Neuron specific enolase (NSE)
NSE should not be evaluated as a marker of brain damage in liver transplantations.

Secondary Outcome Measures

S-100 beta (S100β), and Glial fibrillary acidic protein (GFAP)
Neuroprotective approach protects patients from brain damage during liver transplantation and prevent the development of POCD, which was indicated by the insignificant change in MMT scores and S100β level and the significant decrease in GFAP.

Full Information

First Posted
April 26, 2020
Last Updated
April 28, 2020
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT04368052
Brief Title
Liver Transplant Does it Affect the Brain
Official Title
Evaluation of The Association Between Cognitive Dysfunction and Brain Cellular Damage During Liver Transplantations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
October 11, 2019 (Actual)
Study Completion Date
January 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Neuronal damage caused by neuroinflammation in patients undergoing major surgery is the most determinant factor of postoperative cognitive disfunction (POCD). Neuronal damage can be detected through the measurement of biochemical markers of brain damage. The aim of this study was to evaluate neuronal damage and its association with POCD during liver transplantations. After the approval of the ethics committee and patient consents, preoperative and postoperative cognitive functions of 33 patients undergoing liver transplantation (LTx) were measured using the Mini Mental Test (MMT) whereas simultaneous neuronal damage was evaluated through the measurement of S-100 beta (S100β), Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP) levels. As a result, there was no statistically significant difference between preoperative and postoperative MMTs. However, there was a statistically significant decrease in postoperative GFAP and a statistically significant increase in NSE compared to preoperative values. The decrease in S100β level was statistically insignificant. In conclusion, neuroprotective approaches in the investigator's anesthesia protocol protect patients from brain damage during liver transplantation and prevent the development of POCD, which was indicated by the insignificant change in MMT scores and S100β level and the significant decrease in GFAP. Since the significant increase in NSE levels during liver transplantations was deemed to might have been associated with causes other than neuronal damage, NSE should not be evaluated as a marker of brain damage in these operations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Damage, Postoperative Cognitive Dysfunction, Neuron Specific Enolase, Glial Fibrillary Acidic Protein
Keywords
Liver transplantation, Neuronal damage, Brain, Biochemical marker, Postoperative Cognitive Dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Observation
Arm Type
Other
Arm Description
preoperative and postoperative cognitive functions of 33 patients undergoing liver transplantation (LTx) were measured using the Mini Mental Test (MMT) whereas simultaneous neuronal damage was evaluated through the measurement of S-100 beta (S100β), Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP) levels.
Intervention Type
Diagnostic Test
Intervention Name(s)
Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein
Intervention Description
Patients undergoing liver transplantation (LTx) were measured using the Mini Mental Test (MMT) whereas simultaneous neuronal damage was evaluated through the measurement of S-100 beta (S100β), Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP) levels.
Primary Outcome Measure Information:
Title
Neuron specific enolase (NSE)
Description
NSE should not be evaluated as a marker of brain damage in liver transplantations.
Time Frame
Throughout the operation
Secondary Outcome Measure Information:
Title
S-100 beta (S100β), and Glial fibrillary acidic protein (GFAP)
Description
Neuroprotective approach protects patients from brain damage during liver transplantation and prevent the development of POCD, which was indicated by the insignificant change in MMT scores and S100β level and the significant decrease in GFAP.
Time Frame
Throughout the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Score of 23 or above on the Mini Mental Test (MMT) conducted in the preparation room prior to the operation, No gastrointestinal bleeding in the last 1 month No history of neuroactive drug use Consented for the study. Exclusion Criteria: Hepatic encephalopathy, Neurological disorder Psychiatric disorder,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Sezer, Assoc. Prof.
Organizational Affiliation
Ege University Medical Faculty, Department of Medical Biochemistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University Faculty of Medicine
City
İzmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Liver Transplant Does it Affect the Brain

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