Brain DamageNCT04368052
Liver Transplant Does it Affect the Brain
A study testing Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein in people with Brain Damage and Postoperative Cognitive Dysfunction, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Brain Damage, Postoperative Cognitive Dysfunction, Neuron Specific Enolase
- What is being tested?
- Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2018to 3 Jan 2020
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hepatic encephalopathy,
- Neurological disorder
- Psychiatric disorder,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine
Izmir, 35100
About this study
Official title: Evaluation of The Association Between Cognitive Dysfunction and Brain Cellular Damage During Liver Transplantations
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.
- Conditions
- Brain Damage, Postoperative Cognitive Dysfunction, Neuron Specific Enolase, Glial Fibrillary Acidic Protein
- Being tested
- Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein
- Keywords
- Liver transplantation, Neuronal damage, Brain, Biochemical marker, Postoperative Cognitive Dysfunction
- Medical subject headings
- Brain Injuries, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic proteinDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Other | 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. Receives: Diagnostic Test: Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuron specific enolase (NSE)
NSE should not be evaluated as a marker of brain damage in liver transplantations.
Measured: Throughout the operation
Secondary outcomes (1)
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.
Measured: Throughout the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start27 Feb 2018
- Primary completion11 Oct 2019
- Study completion3 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DamageStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Nuri Deniz, Ege University
- Investigators
- Ebru Sezer, Assoc. Prof., Principal investigator, Ege University Medical Faculty, Department of Medical Biochemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368052
- Sponsor's protocol ID
- 27042020
- Status last verified
- Apr 2020
- First submitted
- 26 Apr 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Association Between Cognitive Dysfunction and Brain Cellular Damage During Liver Transplantations
- ClinicalTrials.gov ID
- NCT04368052
- Acronym / sponsor ID
- 27042020
- Conditions
- Brain Damage, Postoperative Cognitive Dysfunction, Neuron Specific Enolase, Glial Fibrillary Acidic Protein
- Keywords
- Liver transplantation, Neuronal damage, Brain, Biochemical marker, Postoperative Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 29 Apr 2020 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | Other | Diagnostic Test: Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic proteinpreoperative 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Hepatic encephalopathy,
- Neurological disorder
- Psychiatric disorder,
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 |
|---|---|---|
| Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic proteinPatients 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 | Observation |
Primary outcome
Neuron specific enolase (NSE)
Time frame: Throughout the operation
NSE should not be evaluated as a marker of brain damage in liver transplantations.
1 secondary outcome
S-100 beta (S100β), and Glial fibrillary acidic protein (GFAP)
Time frame: Throughout the operation
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 30 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Brain Damage
RecruitingPhase 3
Efficacy of Propranolol in Traumatic Brain Injury Patients Admitted to the ICU: A Prospective, Randomized, Triple-Blind Study
Traumatic Brain Injury (TBI) Patients
Not yet recruiting
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
Concussion (Diagnosis), Gait Abnormality
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Not yet recruiting
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Cerebral Palsy (CP)
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.
Ebru Sezer, Assoc. Prof. principal investigator
Ege University Medical Faculty, Department of Medical Biochemistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein in people with Brain Damage and Postoperative Cognitive Dysfunction, run by Ege University 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 4 inclusion and 3 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 30 Apr 2020. 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?
Neuron specific enolase (NSE) (time frame: Throughout the operation). 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 30 Apr 2020.