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OpenTrials
Completed

NCT Number: NCT04368052

Liver Transplant Does it Affect the Brain

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein

Diagnostic Test

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Evaluation of The Association Between Cognitive Dysfunction and Brain Cellular Damage During Liver Transplantations

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 29, 2020
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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