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Liver TransplantationNCT03453047

S100β and Neuron Specific Enolase Levels in Liver Transplantation

An observational study of Liver Transplantation, run by Bora Dinc at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Several neurological problems which include both central nervous system and peripheral nervous system can occur as a result of acute liver failure or severe chronic liver failure. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Liver Transplantation
What is being tested?
S100β and Neuron specific enolase (NSE)
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jun 2017to 20 May 2021
How long will I take part?
6 Months
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: All living-made approximately 60 transplants shall be accepted.

Who may be able to join

  • All liver transplantation candidates shall be accepted into the study.

Who cannot join

  • Patients who:
  • Refused the study With infection, oncological and hematological diseases, coronary or kidney failure, malnutrition or skull fracture The ones who were transplanted liver from cadaveric Using psychoactive medicine Having respiratory system or central nerve system disease shall be excluded from the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Akdeniz University Medical Faculty Department of Anesthesiology and Reanimation

    Antalya, 07059

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Preoperative and Postoperative S100β and Neuron Specific Enolase Levels in Patients Undergoing Liver Transplantation

Several neurological problems which include both central nervous system and peripheral nervous system can occur as a result of acute liver failure or severe chronic liver failure. The main reason of cerebral damage in liver failure is cellular metabolic changes, long term neuro-inflammation status, activation of brain microglia, accumulation of manganese and ammonia besides acute and severe hyperammoniemia that triggers systemic inflammation. Examples of neurological complications of serious hepatocellular failure are hepatic encephalopathy, diffuse brain edema, Wilson disease, hepatic myelopathy, acquired hepatocerebral degeneration; Parkinsonism induced cirrhosis and osmatic demyelinization. Attentive neurological evaluation is of high importance in order to define seriousness level and distribution of neurologic disorders besides current treatable anomalies and potentially prescribe postoperative prognosis.

S100β is released by astrocytes in brain damage. S100β increases in the beginning of brain damage so it can be used to diagnose early stage brain damage. Neuron specific enolase (NSE) acts as intracytoplasmic enzyme and increases serum levels in neuron damage.

The aim of the study is to evaluate neurological damage and analyze its effect on prognosis by considering S100β and NSE levels in liver transplantation.

Read the detailed description

Neurologic disorders that affect the liver transplantation candidates when they are on the waitlist not only significantly affect preoperative morbidity and even mortality but also present important predictive factors for post-op neurologic manifestations. Attentive neurological evaluation before transplantation plays a significant role in defining seriousness level and distribution of neurologic disorders besides current treatable anomalies and potentially prescribe postoperative prognosis. Preferred specific indexes of neurological evaluation before transplantation can vary according to centers but correct diagnosis and definitive diagnosis of some syndromes can be difficult despite using current biochemical, neurophysiologic, neuropsychological and neuroimaging diagnosis tools.

Liver transplant receivers constitute the group with the most frequent central nervous system complication (incidence: 10%-85%) amongst the organ transplantation patients. They are focal or diffuse neurologic deficits creating a significant obstacle for short and long term recovery. Neurologic deficits which can develop are cerebral edema, increase of intracranial pressure, metabolic encephalopathy, cerebrovascular complications, osmotic demyelination syndrome and opportunistic infections. Moreover, several preoperative neurologic disorders (such as dysarthria akinetic mutism, confusion and seizures) can get worse due to neurotoxic side effect of the medicines which are used for preventing graft rejection (calcineurin inhibitors).

Neurologic findings and pathophysiology of end stage liver failure cannot be understood completely. Multiple factors such as long term brain "neuroinflammation", brain microglia, activation of inflammatory cells, accumulation of manganese and ammonia, changing blood-brain barrier permeability, changed nerve conduction and inflammation of peripheric nerve system inflammation are held responsible from brain damage. Other negative direct or indirect neurologic effects are chronical malnutrition, gastrointestinal bleeding, cerebral hypoperfusion and renal dysfunction. The most commonly accepted neurological complications of serious hepatocellular insufficiency are complex syndromes of hepatic encephalopathy (HE).

S100β is 10.4 kDa (kilodalton) protein. Synthesized with end feet processes of astrocytes in the brain S100β belongs to low molecular weight EF-hand type acidic calcium binding protein superfamily. This protein is metabolized in the kidneys and removed with urine. It is shown that S100β does not show differences due to ethnical groups or genders and is not affected by circadian rhythm. Although S100β is also found in other tissues, it is in higher concentrations in the brain so it can be used as an early indicator for brain damage.

Astrocytes are the keys to homeostasis regulation in central nervous system (CNS) and release S100β after brain damage. Some studies conducted that, increased S100β levels as an early indicator for intracerebral changes within patients with acute or chronical liver failure and before cerebral edema is developed in HE.

Moreover, it is also asserted that S100β increase in serum concentration can foresee HE. Additionally, there are limited evidences to prove S100β levels and existence of HE.

NSE is an CNS protein which exists in neurons and neuroendocrine tissues. NSE plays a role in glycolytic route in neurons as intracytoplasmic enzyme increasing serum level in case of neuron damage. Whilst S100β is the marker of astroglia dysfunction, NSE is the marker of neuronal dysfunction.

The aim of the study is analyzing S100β serum concentrations and correlate neurologic damage of liver transplantation patients besides evaluating its effect on prognosis.

Being tested
S100β and Neuron specific enolase (NSE)
Keywords
S100β, Neuron specific enolase, Liver transplantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S100β and Neuron specific enolase (NSE)Diagnostic test

    S100β is 10.4 kDa protein. Synthesized with end feet processes of astrocytes in the brain S100β belongs to low molecular weight EF-hand type acidic calcium binding protein superfamily. This protein is metabolized in the kidneys and removed with urine. It is shown that S100β does not show differences due to ethnical groups or genders and is not affected by circadian rhythm. Although S100β is also found in other tissues, it is in higher concentrations in the brain so it can be used as an early indicator for brain damage.NSE is an SSS protein which exists in neurons and neuroendocrine tissues. NSE plays a role in glycolytic route in neurons as intracytoplasmic enzyme increasing serum level in case of neuron damage. Whilst S100β is the marker of astroglia dysfunction, NSE is the marker of neuronal dysfunction.

Study groups in NCT03453047
Study groupRoleWhat they receive
1Healthy volunteers. Liver donor groups; Course of the research: Blood samples from all groups shall be taken for S100β and NSE in preoperative period, in the operating room and after 1 and 6 months in postoperative period. Mortality and morbidity of the patients shall be recorded. Neurological damage and its effect on prognosis shall be examined within the patients who were transplanted liver with S100β and NSE. Demographic data of the patients, accompanying diseases, American Society of Anesthesia classification, etiology, Model For End-Stage Liver Disease score, Child classification, sodium, potassium, total bilirubin, alanine aminotransferase, aspartate aminotransferase, Alkaline phosphatase, International Normalized Ratio, creatinine and urea shall be recorded. Intraoperative medicine administration and fluid balance, duration of operation, graft hot ischemia and graft cold ischemia durations, initial pulmonary artery pressure, blood component transplantations shall be recorded.
Receives: Diagnostic Test: S100β and Neuron specific enolase (NSE)
2Liver transplant groups;Course of the research Blood samples from all groups shall be taken for S100β and NSE in preoperative period, in the operating room and after 1 and 6 months in postoperative period. Mortality and morbidity of the patients shall be recorded. Neurological damage and its effect on prognosis shall be examined within the patients who were transplanted liver with S100β and NSE. Demographic data of the patients, accompanying diseases, American Society of Anesthesia classification, etiology, Model For End-Stage Liver Disease score, Child classification, sodium, potassium, total bilirubin, alanine aminotransferase, aspartate aminotransferase, Alkaline phosphatase, International Normalized Ratio, creatinine and urea shall be recorded. Intraoperative medicine administration and fluid balance, duration of operation, graft hot ischemia and graft cold ischemia durations, initial pulmonary artery pressure, blood component transplantations shall be recorded.
Receives: Diagnostic Test: S100β and Neuron specific enolase (NSE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Analyze S100β serum concentrations

    Blood sample is taken in preoperative period before induction of anesthesia in the operating room to analyze S100β serum concentrations and neurologic damage of liver transplantation patients besides evaluating its effect on prognosis.

    Measured: before induction

  2. Analyze S100β serum concentrations

    Blood sample is taken first month in postoperative period to analyze S100β serum concentrations and neurologic damage of liver transplantation patients besides evaluating its effect on prognosis

    Measured: first month

  3. Analyze S100β serum concentrations

    Blood sample is taken sixth month in postoperative period to analyze S100β serum concentrations and neurologic damage of liver transplantation patients besides evaluating its effect on prognosis.

    Measured: sixth month

Secondary outcomes (3)
  1. Analyze Neuron specific Enolase serum concentrations

    Blood sample is taken in preoperative period before induction of anesthesia in the operating room to analyze Neuron specific Enolase serum concentrations and neurologic damage of liver transplantation patients besides evaluating its effect on prognosis.

    Measured: before induction

  2. Analyze Neuron specific Enolase serum concentrations

    Blood sample is taken first month in postoperative period to analyze Neuron specific Enolase serum concentrations and neurologic damage of liver transplantation patients besides evaluating its effect on prognosis.

    Measured: first month

  3. Analyze Neuron specific Enolase serum concentrations

    Blood sample is taken sixth month in postoperative period to analyze Neuron specific Enolase serum concentrations and neurologic damage of liver transplantation patients besides evaluating its effect on prognosis.

    Measured: sixth month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2018
  2. Study start20 Jun 2017
  3. Primary completion1 Mar 2021
  4. Study completion20 May 2021

Resources

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
Other
Time perspective
Prospective
Enrolment
60 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03453047
Sponsor's protocol ID
LIVER
Status last verified
Jul 2021
First submitted
30 Jan 2018
Last updated
28 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The aim of the study is to evaluate neurological damage and analyze its effect on prognosis by considering S100β and NSE levels in liver transplantation.

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Transplantation, run by Bora Dinc at 1 site in Turkey (Türkiye).

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 1 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 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Analyze S100β serum concentrations (time frame: before induction). The study lists 3 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 28 Jul 2021.

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