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Liver Transplant Does it Affect the Brain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368052
Recruitment Status : Completed
First Posted : April 29, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Mustafa Nuri Deniz, Ege University

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.

Condition or disease Intervention/treatment Phase
Brain Damage Postoperative Cognitive Dysfunction Neuron Specific Enolase Glial Fibrillary Acidic Protein Diagnostic Test: Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of The Association Between Cognitive Dysfunction and Brain Cellular Damage During Liver Transplantations
Actual Study Start Date : February 27, 2018
Actual Primary Completion Date : October 11, 2019
Actual Study Completion Date : January 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Observation
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.
Diagnostic Test: Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein
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 Measures :
  1. Neuron specific enolase (NSE) [ Time Frame: Throughout the operation ]
    NSE should not be evaluated as a marker of brain damage in liver transplantations.


Secondary Outcome Measures :
  1. S-100 beta (S100β), and Glial fibrillary acidic protein (GFAP) [ Time Frame: Throughout the operation ]
    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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368052


Locations
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Turkey
Ege University Faculty of Medicine
İzmir, Turkey, 35100
Sponsors and Collaborators
Ege University
Investigators
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Principal Investigator: Ebru Sezer, Assoc. Prof. Ege University Medical Faculty, Department of Medical Biochemistry
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Responsible Party: Mustafa Nuri Deniz, Assoc. Prof, Ege University
ClinicalTrials.gov Identifier: NCT04368052    
Other Study ID Numbers: 27042020
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mustafa Nuri Deniz, Ege University:
Liver transplantation
Neuronal damage
Brain
Biochemical marker
Postoperative Cognitive Dysfunction
Additional relevant MeSH terms:
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Brain Injuries
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries