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).
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
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.
- Conditions
- Liver Transplantation
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Healthy 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) | |
| 2 | Liver 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.
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
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
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)
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
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
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.
- First posted5 Mar 2018
- Study start20 Jun 2017
- Primary completion1 Mar 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Bora Dinc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bora Dinc, Akdeniz University
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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Preoperative and Postoperative S100β and Neuron Specific Enolase Levels in Patients Undergoing Liver Transplantation
- ClinicalTrials.gov ID
- NCT03453047
- Acronym / sponsor ID
- LIVER
- Conditions
- Liver Transplantation
- Keywords
- S100β, Neuron specific enolase, Liver transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bora DincUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 5 Mar 2018 (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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: S100β and Neuron specific enolase (NSE)Healthy 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. |
| 2 | – | Diagnostic Test: S100β and Neuron specific enolase (NSE)Liver 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All living-made approximately 60 transplants shall be accepted.
Key inclusion criteria (1 listed)
- All liver transplantation candidates shall be accepted into the study.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S100β and Neuron specific enolase (NSE)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. | Diagnostic test | 1, 2 |
Primary outcome
Analyze S100β serum concentrations
Time frame: before induction
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.
Analyze S100β serum concentrations
Time frame: first month
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
Analyze S100β serum concentrations
Time frame: sixth month
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.
3 secondary outcomes
Analyze Neuron specific Enolase serum concentrations
Time frame: before induction
Analyze Neuron specific Enolase serum concentrations
Time frame: first month
Analyze Neuron specific Enolase serum concentrations
Time frame: sixth month
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 28 Jul 2021.
- Individual participant dataSharing planned: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.