Carotid Artery DiseasesPhase 3NCT05126238
A Lithium-Based Medication to Improve Neurological Outcomes After Surgical Carotid Reconstruction
A Phase 3 study testing Lithium Carbonate in people with Carotid Artery Diseases and Carotid Artery Stenosis, run by Negovsky Reanimatology Research Institute at 1 site in Russia.
Trial summary
There are 10.3 million cases of stroke registered in the world every year; 63% of them lead to death. According to World Health Organization, stroke is one of the most important risk factors of death and early disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Diseases, Carotid Artery Stenosis
- What is being tested?
- Lithium Carbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteRussia
- Study dates
- 20 Nov 2021to 19 May 2025
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- elective carotid artery surgery
- general anesthesia
- written informed consent
Who cannot join
- urgent surgery
- recent ( < 1 month) overt stroke
- Mini-mental State Examination < 20 points
- The presence of any mental disorder according to the International Classification of Diseases 11th Revision which is confirmed by a psychiatrist.
- The presence of any neuromuscular disease according to the International Classification of Diseases 11th Revision
- Hypersensitivity or known allergy to lithium carbonate
Show all 14Show fewer
- History of seizure disorder
- History of leukemia
- Estimated glomerular filtration rate < 30 ml/min/1.73 m2
- Left ventricular ejection fraction < 30%
- Heart failure equal 3 or 4 class according to the New York Heart Association Functional Classification
- Pregnant or breast-feeding women
- Inability to undergo a preoperative assessment for any reason
- Previously enrolled in this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Lithium-Based Medication to Improve Neurological Outcomes After Surgical Carotid Reconstruction: A Double-Blind, Placebo Control Randomized Trial (BINOS)
There are 10.3 million cases of stroke registered in the world every year; 63% of them lead to death. According to World Health Organization, stroke is one of the most important risk factors of death and early disability.
Carotid artery surgery is a gold standard of hemodynamically significant carotid artery disease treatment. According to some trials, carotid artery surgery decreases the 2-years mortality.
Read more
The most important part of carotid artery surgery is a temporary absence of blood flow in the carotid artery. The duration of this period is a crucial characteristic of this type of surgery. The absence of blood flow leads to brain ischemia which is the risk factor of postoperative neurocognitive disorders such as emergence delirium, postoperative delirium and postoperative cognitive dysfunction.
Some surgical and non-surgical methods for brain protection were evaluated. According to recent data, there is no evidence of effective pharmacological protective methods that can decrease brain damage during carotid artery surgery.
Nevertheless, some trials demonstrated that using lithium-based medications for patients with a stroke can reduce the volume of the stroke. Therefore, the investigators want to check the hypothesis that using lithium-based medication in the preoperative period can reduce brain damage during carotid artery surgery.
The objectives of this trial:
- To determine if Lithium carbonate is superior to placebo for the occurrence of emergence delirium, agitation, postoperative delirium and postoperative cognitive dysfunction.
- To determine if Lithium carbonate is non-inferior to placebo for the occurrence of a new arrhythmia, leukocytosis, acute kidney injury, seizure disorders, diarrhea, nausea, and vomit.
Read the detailed description
There are 10.3 million cases of stroke registered in the world every year; 63% of them lead to death. According to World Health Organization, stroke is one of the most important risk factors of death and early disability.
Carotid artery surgery is a gold standard of hemodynamically significant carotid artery disease treatment. According to some trials, carotid artery surgery decreases the 2-years mortality.
The most important part of carotid artery surgery is a temporary absence of blood flow in the carotid artery. The duration of this period is a crucial characteristic of this type of surgery. The absence of blood flow leads to brain ischemia which is the risk factor of postoperative neurocognitive disorders such as emergence delirium, postoperative delirium and postoperative cognitive dysfunction.
Some surgical and non-surgical methods for brain protection were evaluated. According to recent data, there is no evidence of effective pharmacological protective methods that can decrease brain damage during carotid artery surgery.
Nevertheless, some trials demonstrated that using lithium-based medications for patients with a stroke can reduce the volume of the stroke. Therefore, the investigators want to check the hypothesis that using lithium-based medication in the preoperative period can reduce brain damage during carotid artery surgery.
The objectives of this trial:
To determine if Lithium carbonate is superior to placebo for the occurrence of emergence delirium, agitation, postoperative delirium and postoperative cognitive dysfunction.
To determine if Lithium carbonate is non-inferior to placebo for the occurrence of a new arrhythmia, leukocytosis, acute kidney injury, seizure disorders, diarrhea, nausea, and vomit.
- Conditions
- Carotid Artery Diseases, Carotid Artery Stenosis
- Being tested
- Lithium Carbonate, Placebo
- Keywords
- Carotid artery diseases, Carotid artery stenosis, Carotid artery surgery, Lithium, Neurocognitive disorders, Postoperative cognitive disorders, Postoperative delirium, Emergence delirium, Agitation, Stroke, Neuroinflammation
- Medical subject headings
- Carotid Artery Diseases, Carotid Stenosis, Neurocognitive Disorders, Postoperative Cognitive Complications, Emergence Delirium, Psychomotor Agitation, Stroke, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium CarbonateDrug
In preoperative period patients will take 300 mg of lithium carbonate on 1-1-1 regimen during 2 days prior to surgery. On the day of surgery they will take 300mg of lithium carbonate 2 hours before surgery.
PlaceboDrug
In preoperative period patients will take placebo on 1-1-1 regimen during 2 days prior to surgery. On the day of surgery they will placebo 2 hours before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Lithium | Experimental | In preoperative period patients will take 300mg of lithium carbonate on 1-1-1 regimen during 2 days prior to surgery. On the day of surgery, they will take 300mg of lithium carbonate 2 hours before surgery. After the surgery, patients will take 300mg of lithium carbonate in the afternoon and 300mg of lithium carbonate in the evening. Receives: Drug: Lithium Carbonate |
| Placebo | Placebo comparator | In preoperative period patients will take placebo on 1-1-1 regimen during 2 days prior to surgery. On the day of surgery, they will take placebo 2 hours before surgery. After the surgery, patients will take placebo in the afternoon and in the evening. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of emergence delirium
Number of patients with positive the confusion assessment method for the intensive care unit as soon as they reach Aldrete score of 9 points
Measured: 30 days
Secondary outcomes (27)
Frequency of agitation
Richmond agitation-sedation scale more or equal +2 evaluated from the end of volatile anesthetic supply to the moment when a patient reaches Aldrete score of 9 points
Richmond agitation-sedation scale:
minimum value = -5 (Unarousable - no response to voice or physical stimulation) maximum value = +4 (Combative - overtly combative or violent; immediate danger to staff) Adequate patients have the results of Richmond agitation-sedation score equal 0 (Alert and calm; Spontaneously pays attention to caregiver)
Measured: 30 days
Frequency of postoperative delirium
Number of patients with even one positive confusion assessment method for the intensive care unit or 3-minute confusion assessment method
Measured: 30 days
Length of postoperative delirium
30 days - number of days in which patient had positive confusion assessment method for the intensive care unit or 3-minute confusion assessment method
Measured: until 1 month after surgery
Frequency of overt strokes
Number of overt strokes
Measured: 1 year
Frequency of covert strokes
Number of covert strokes
Measured: 1 year
Length of stay in intensive care unit
Number of days in intensive care unit
Measured: 1 month
Length of hospitalization
Number of days in hospital
Measured: 1 month
Frequency of cardiac death
Number of of cardiac deaths
Measured: 1 year
Frequency of non-fatal cardiac arrest
Number of non-fatal cardiac arrests
Measured: 1 year
Frequency of major adverse cardiac event
Number of major adverse cardiac events
Measured: 1 year
Frequency of major adverse cardiac and cognitive event
Number of major adverse cardiac and cognitive events
Measured: 1 year
30-days mortality
Number of deaths in period of 30 days after surgery
Measured: 30 days
1-year mortality
Number of deaths in period of 1 year after surgery
Measured: 1 year
Frequency of new postoperative arrhythmia
Number of new postoperative arrhythmias
Measured: 1 month
Frequency of leukocytosis
Number of patients with leukocytosis
Measured: From 2 days before surgery to the day of surgery
Frequency of acute diarrhea
Number of patients with acute diarrhea
Measured: From 2 days before surgery to the day of surgery
Frequency of postoperative nausea and vomit
Number of patients with postoperative nausea and vomit
Measured: 1 month
Frequency of preoperative nausea and vomit
Number of patients with preoperative nausea and vomit
Measured: From 2 days before surgery to the day of surgery
Frequency of acute kidney injury
Number of patients with acute kidney injury
Measured: 1 month
Frequency of myasthenia
Number of patients with myasthenia
Measured: From 2 days before surgery to the day of surgery
Frequency of preoperative seizure
Number of patients with seizure
Measured: From 2 days before surgery to the day of surgery
Frequency of postoperative seizure
Number of patients with seizure
Measured: 1 month
Serum level of S100 beta protein
Serum level of S100 beta protein
Measured: 2 days after surgery
Serum level of neuron-specific enolase
Serum level of neuron-specific enolase
Measured: 2 days after surgery
Serum level of Tau-protein
Serum level of Tau-protein
Measured: 2 days after surgery
Serum level of Neurofilament light polypeptide
Serum level of Neurofilament light polypeptide
Measured: 2 days after surgery
Serum level of Glial fibrillary acidic protein
Serum level of Glial fibrillary acidic protein
Measured: 2 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start20 Nov 2021
- Primary completion19 May 2025
- Study completion19 May 2025
Why it stopped: Decision of the local ethics committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Negovsky Reanimatology Research Institute
- Sponsor type
- Other government
- Collaborators
- Demikhov Municipal Clinical Hospital 68
- Responsible party
- Principal investigator, Valery Likhvantsev, MD, Negovsky Reanimatology Research Institute
- Investigators
- Valery Likhvantsev, PhD, Principal investigator, Negovsky Reanimatology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126238
- Sponsor's protocol ID
- BINOS
- Status last verified
- Sep 2025
- First submitted
- 1 Oct 2021
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Lithium-Based Medication to Improve Neurological Outcomes After Surgical Carotid Reconstruction: A Double-Blind, Placebo Control Randomized Trial (BINOS)
- ClinicalTrials.gov ID
- NCT05126238
- Acronym / sponsor ID
- BINOS
- Conditions
- Carotid Artery Diseases, Carotid Artery Stenosis
- Keywords
- Carotid artery diseases, Carotid artery stenosis, Carotid artery surgery, Lithium, Neurocognitive disorders, Postoperative cognitive disorders, Postoperative delirium, Emergence delirium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision of the local ethics committee
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Negovsky Reanimatology Research InstituteOther government
- Collaborators
- Demikhov Municipal Clinical Hospital 68
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 18 Nov 2021 (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.
There are 10.3 million cases of stroke registered in the world every year; 63% of them lead to death. According to World Health Organization, stroke is one of the most important risk factors of death and early disability.
Carotid artery surgery is a gold standard of hemodynamically significant carotid artery disease treatment. According to some trials, carotid artery surgery decreases the 2-years mortality.
The most important part of carotid artery surgery is a temporary absence of blood flow in the carotid artery. The duration of this period is a crucial characteristic of this type of surgery. The absence of blood flow leads to brain ischemia which is the risk factor of postoperative neurocognitive disorders such as emergence delirium, postoperative delirium and postoperative cognitive dysfunction.
Some surgical and non-surgical methods for brain protection were evaluated. According to recent data, there is no evidence of effective pharmacological protective methods that can decrease brain damage during carotid artery surgery.
Nevertheless, some trials demonstrated that using lithium-based medications for patients with a stroke can reduce the volume of the stroke. Therefore, the investigators want to check the hypothesis that using lithium-based medication in the preoperative period can reduce brain damage during carotid artery surgery.
The objectives of this trial:
- To determine if Lithium carbonate is superior to placebo for the occurrence of emergence delirium, agitation, postoperative delirium and postoperative cognitive dysfunction.
- To determine if Lithium carbonate is non-inferior to placebo for the occurrence of a new arrhythmia, leukocytosis, acute kidney injury, seizure disorders, diarrhea, nausea, and vomit.
Detailed description
There are 10.3 million cases of stroke registered in the world every year; 63% of them lead to death. According to World Health Organization, stroke is one of the most important risk factors of death and early disability.
Carotid artery surgery is a gold standard of hemodynamically significant carotid artery disease treatment. According to some trials, carotid artery surgery decreases the 2-years mortality.
The most important part of carotid artery surgery is a temporary absence of blood flow in the carotid artery. The duration of this period is a crucial characteristic of this type of surgery. The absence of blood flow leads to brain ischemia which is the risk factor of postoperative neurocognitive disorders such as emergence delirium, postoperative delirium and postoperative cognitive dysfunction.
Some surgical and non-surgical methods for brain protection were evaluated. According to recent data, there is no evidence of effective pharmacological protective methods that can decrease brain damage during carotid artery surgery.
Nevertheless, some trials demonstrated that using lithium-based medications for patients with a stroke can reduce the volume of the stroke. Therefore, the investigators want to check the hypothesis that using lithium-based medication in the preoperative period can reduce brain damage during carotid artery surgery.
The objectives of this trial:
To determine if Lithium carbonate is superior to placebo for the occurrence of emergence delirium, agitation, postoperative delirium and postoperative cognitive dysfunction.
To determine if Lithium carbonate is non-inferior to placebo for the occurrence of a new arrhythmia, leukocytosis, acute kidney injury, seizure disorders, diarrhea, nausea, and vomit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lithium | Experimental | Drug: Lithium CarbonateIn preoperative period patients will take 300mg of lithium carbonate on 1-1-1 regimen during 2 days prior to surgery. On the day of surgery, they will take 300mg of lithium carbonate 2 hours before surgery. After the surgery, patients will take 300mg of lithium carbonate in the afternoon and 300mg of lithium carbonate in the evening. |
| Placebo | Placebo comparator | Drug: PlaceboIn preoperative period patients will take placebo on 1-1-1 regimen during 2 days prior to surgery. On the day of surgery, they will take placebo 2 hours before surgery. After the surgery, patients will take placebo in the afternoon and in the evening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 years
- elective carotid artery surgery
- general anesthesia
- written informed consent
Key exclusion criteria (14 listed)
- urgent surgery
- recent ( < 1 month) overt stroke
- Mini-mental State Examination < 20 points
- The presence of any mental disorder according to the International Classification of Diseases 11th Revision which is confirmed by a psychiatrist.
- The presence of any neuromuscular disease according to the International Classification of Diseases 11th Revision
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 |
|---|---|---|
| Lithium CarbonateIn preoperative period patients will take 300 mg of lithium carbonate on 1-1-1 regimen during 2 days prior to surgery. On the day of surgery they will take 300mg of lithium carbonate 2 hours before surgery. | Drug | Lithium |
| PlaceboIn preoperative period patients will take placebo on 1-1-1 regimen during 2 days prior to surgery. On the day of surgery they will placebo 2 hours before surgery. | Drug | Placebo |
Primary outcome
Frequency of emergence delirium
Time frame: 30 days
Number of patients with positive the confusion assessment method for the intensive care unit as soon as they reach Aldrete score of 9 points
27 secondary outcomes
Frequency of agitation
Time frame: 30 days
Frequency of postoperative delirium
Time frame: 30 days
Length of postoperative delirium
Time frame: until 1 month after surgery
Frequency of overt strokes
Time frame: 1 year
Frequency of covert strokes
Time frame: 1 year
Length of stay in intensive care unit
Time frame: 1 month
Length of hospitalization
Time frame: 1 month
Frequency of cardiac death
Time frame: 1 year
Frequency of non-fatal cardiac arrest
Time frame: 1 year
Frequency of major adverse cardiac event
Time frame: 1 year
Frequency of major adverse cardiac and cognitive event
Time frame: 1 year
30-days mortality
Time frame: 30 days
1-year mortality
Time frame: 1 year
Frequency of new postoperative arrhythmia
Time frame: 1 month
Frequency of leukocytosis
Time frame: From 2 days before surgery to the day of surgery
Frequency of acute diarrhea
Time frame: From 2 days before surgery to the day of surgery
Frequency of postoperative nausea and vomit
Time frame: 1 month
Frequency of preoperative nausea and vomit
Time frame: From 2 days before surgery to the day of surgery
Frequency of acute kidney injury
Time frame: 1 month
Frequency of myasthenia
Time frame: From 2 days before surgery to the day of surgery
Frequency of preoperative seizure
Time frame: From 2 days before surgery to the day of surgery
Frequency of postoperative seizure
Time frame: 1 month
Serum level of S100 beta protein
Time frame: 2 days after surgery
Serum level of neuron-specific enolase
Time frame: 2 days after surgery
Serum level of Tau-protein
Time frame: 2 days after surgery
Serum level of Neurofilament light polypeptide
Time frame: 2 days after surgery
Serum level of Glial fibrillary acidic protein
Time frame: 2 days after surgery
Results and safety
The study was stopped early (reason given: Decision of the local ethics committee). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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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.
Valery Likhvantsev, PhD principal investigator
Negovsky Reanimatology Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lithium Carbonate in people with Carotid Artery Diseases and Carotid Artery Stenosis, run by Negovsky Reanimatology Research Institute at 1 site in Russia.
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 14 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: stopped early, as of the sponsor's last update on 25 Sep 2025. 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 Russia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Decision of the local ethics committee). Results are not available in the source record.
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?
Frequency of emergence delirium (time frame: 30 days). 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 25 Sep 2025.