AstrogliosisNCT03683537
Association Between Changes of GFAP After Surgery and Postoperative Delayed Cognitive Recovery
An observational study of Astrogliosis and Postoperative Cognitive Dysfunction, run by Moscow Clinical Scientific Center at 1 site in Russia.
Trial summary
Assessment of serum level of glial fibrillary acidic protein (GFAP) before surgery (on the day of surgery), 24 hours after surgery and on 3 or 4 postoperative day. Neuropsychological testing before surgery and on 3 or 4 day after surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Astrogliosis, Postoperative Cognitive Dysfunction, Postoperative Delirium
- What is being tested?
- Glial fibrillary acidic protein
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 15 Feb 2018to 15 Dec 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who undergo surgery in Moscow Clinical Scientific Center
Who may be able to join
- Patients with different diseases, who require prolonged laparoscopy or open surgery
- Age more than 60
- ASA I-III
- Informed consent to participate in the study
Who cannot join
- ASA IV-V
- Severe neurodegenerative or psychological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of serum level of glial fibrillary acidic protein (GFAP) before surgery (on the day of surgery), 24 hours after surgery and on 3 or 4 postoperative day. Neuropsychological testing before surgery and on 3 or 4 day after surgery. Investigation of relationship between changes of GFAP and scores of neuropsychological tests.
- Being tested
- Glial fibrillary acidic protein
- Medical subject headings
- Gliosis, Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glial fibrillary acidic proteinDiagnostic test
3 samples of serum are drawn from patients. The 1st Sample of patient serum is drawn before induction into anesthesia. The 2nd is drawn 24 hours after the 1st one. The 3rd sample is drawn on 3 or 4 postoperative day. All samples collected and preserved in the same temperature as required for ELISA.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Neurocognitive decline | Patients in whom there is Delayed Neurocognitive Recovery (DNR) after surgery, based on neuropsychological tests or clinically. DNR is defined as follow: 1)decrease of scores of neuropsychological test scores for more than 1 standard deviation (SD) of these tests; 2)clinically - inability of patient to perform test after surgery because of neurocognitive impairment. Receives: Diagnostic Test: Glial fibrillary acidic protein | |
| Normal postop neurocognitive function | Patients in whom there is no clinical signs of DNR, defined as in previous group. Receives: Diagnostic Test: Glial fibrillary acidic protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum GFAP
GFAP(3) - GFAP (1); GFAP (2) - GFAP (1)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start15 Feb 2018
- Primary completion15 Nov 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstrogliosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Clinical Scientific Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valery Subbotin, Ph.D., M.D., Study chair, Moscow Clinical Scintific Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683537
- Sponsor's protocol ID
- MKNC 02/2018
- Status last verified
- May 2025
- First submitted
- 20 Sep 2018
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Changes of GFAP After Surgery and Postoperative Delayed Cognitive Recovery
- ClinicalTrials.gov ID
- NCT03683537
- Acronym / sponsor ID
- MKNC 02/2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Moscow Clinical Scientific CenterUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 25 Sep 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.
Assessment of serum level of glial fibrillary acidic protein (GFAP) before surgery (on the day of surgery), 24 hours after surgery and on 3 or 4 postoperative day. Neuropsychological testing before surgery and on 3 or 4 day after surgery. Investigation of relationship between changes of GFAP and scores of neuropsychological tests.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Neurocognitive decline | – | Diagnostic Test: Glial fibrillary acidic proteinPatients in whom there is Delayed Neurocognitive Recovery (DNR) after surgery, based on neuropsychological tests or clinically. DNR is defined as follow: 1)decrease of scores of neuropsychological test scores for more than 1 standard deviation (SD) of these tests; 2)clinically - inability of patient to perform test after surgery because of neurocognitive impairment. |
| Normal postop neurocognitive function | – | Diagnostic Test: Glial fibrillary acidic proteinPatients in whom there is no clinical signs of DNR, defined as in previous group. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who undergo surgery in Moscow Clinical Scientific Center
Key inclusion criteria (4 listed)
- Patients with different diseases, who require prolonged laparoscopy or open surgery
- Age more than 60
- ASA I-III
- Informed consent to participate in the study
Key exclusion criteria (2 listed)
- ASA IV-V
- Severe neurodegenerative or psychological diseases
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 |
|---|---|---|
| Glial fibrillary acidic protein3 samples of serum are drawn from patients. The 1st Sample of patient serum is drawn before induction into anesthesia. The 2nd is drawn 24 hours after the 1st one. The 3rd sample is drawn on 3 or 4 postoperative day. All samples collected and preserved in the same temperature as required for ELISA. | Diagnostic test | Delayed Neurocognitive decline, Normal postop neurocognitive function |
Primary outcome
Changes in serum GFAP
Time frame: 1 year
GFAP(3) - GFAP (1); GFAP (2) - GFAP (1)
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 9 May 2025.
- Individual participant dataSharing planned: Undecided
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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 Subbotin, Ph.D., M.D. study chair
Moscow Clinical Scintific Center
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 Astrogliosis and Postoperative Cognitive Dysfunction, run by Moscow Clinical Scientific Center 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 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 9 May 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. 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?
Changes in serum GFAP (time frame: 1 year). 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 9 May 2025.