Neurological Complication of Procedure (Disorder)BINERNCT03493256

Novel BIochemical Markers for Predicting Type 2 NEurological Complications of Surgical Coronary Revascularization (BINER)

An observational study of Neurological Complication of Procedure (Disorder), run by Collegium Medicum w Bydgoszczy at 1 site in Poland.

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

Who is it for?: Any age
Conditions the study is for: Neurological Complication of Procedure (Disorder)
What is being tested?: exposure to type 2 neurological complications
How many people: 100 participants
Where: 1 sitePoland
Study dates: 1 Apr 2018to 1 Mar 2019
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 Any age
All sexes
Child, Adult, Older adult

Study population: All participants will be recruited from patients scheduled for elective off-pump CABG at the Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital, Bydgoszcz, Poland.

Who may be able to join

patients scheduled for elective off-pump Coronary Artery Bypass Grafting (CABG)

Who cannot join

neurological or psychiatric disorders
alcohol or drug abuse
preoperative left ventricular ejection fraction of less than 30%
extracranial carotid artery stenosis of more than 70%
scoring below age- and education-adjusted cut-off values in Mini-Mental State Examination (MMSE)
scoring over seven points on the subscales of the Hospital Anxiety and Depression Scale (HADS)

Trial locations and contacts

1 site in 1 country.

Poland1 site

Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094

Other trials in Poland

About this study

Official title: Novel BIochemical Markers for Predicting Type 2 NEurological Complications of Surgical Coronary Revascularization (BINER): a Prospective Cohort Study.

In this single center prospective cohort study a total of 100 patients scheduled for elective off-pump CABG will be recruited. They will be allocated to one study and one control group according to the presence or absence of postoperative type 2 neurological complications. The two groups will be compared in terms of serum concentrations of glial fibrillary acidic protein (GFAP), neuroserpin (NSP), phosphorylated axonal neurofilament subunit H (pNfH) and visinin-like protein 1 (VILIP-1) at the time of skin incision and closure as well as 24 hours and 7 days following surgery. Diagnostic performance of these markers for predicting type 2 neurological complications of off-pump CABG will be assessed.

Conditions: Neurological Complication of Procedure (Disorder)
Being tested: exposure to type 2 neurological complications

What participants receive

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

exposure to type 2 neurological complicationsOther
exposure to postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.

Study groups in NCT03493256
Study group	Role	What they receive
type 2 neurological complications present		The group of patients diagnosed with postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently. Receives: Other: exposure to type 2 neurological complications
type 2 neurological complications absent		The group of patients without neurological complications.

What is being measured

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

Assessment of serum GFAP concentration (ng/ml) changes.
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of glial fibrillary acidic protein (GFAP).
Measured: GFAP concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Assessment of serum NSP concentration (ng/ml) changes.
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of neuroserpin (NSP).
Measured: NSP concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Assessment of serum pNfH concentration (ng/ml) changes.
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of neuroserpin phosphorylated axonal neurofilament subunit H (pNfH).
Measured: pNfH concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Assessment of serum VILIP-1 concentration (ng/ml) changes.
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of visinin-like protein 1 (VILIP-1).
Measured: VILIP-1 concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).

Timeline

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

1 Apr 20181 Mar 2019

First posted10 Apr 2018
Study start1 Apr 2018
Primary completion1 Mar 2019
Study completion1 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neurological Complication of Procedure (Disorder)Studies 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: Cohort
Time perspective: Prospective
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03493256
Sponsor's protocol ID: KB 776/2017
Acronym: BINER
Status last verified: Feb 2020
First submitted: 26 Mar 2018
Last updated: 5 Feb 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Neurological Complication of Procedure (Disorder) trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Novel BIochemical Markers for Predicting Type 2 NEurological Complications of Surgical Coronary Revascularization (BINER): a Prospective Cohort Study.
ClinicalTrials.gov ID: NCT03493256
Acronym / sponsor ID: BINER / KB 776/2017
Conditions: Neurological Complication of Procedure (Disorder)
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Collegium Medicum w BydgoszczyUniversity, hospital or other
Study start: 1 Apr 2018 (actual)
Primary completion: 1 Mar 2019 (actual)
Study completion: 1 Mar 2019 (actual)
First posted: 10 Apr 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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
type 2 neurological complications present	–	Other: exposure to type 2 neurological complicationsThe group of patients diagnosed with postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.
type 2 neurological complications absent	–	–The group of patients without neurological complications.

Who may qualify

Sex: All
Age groups: Child, Adult, Older adult
Study population: All participants will be recruited from patients scheduled for elective off-pump CABG at the Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital, Bydgoszcz, Poland.

Key inclusion criteria (1 listed)

patients scheduled for elective off-pump Coronary Artery Bypass Grafting (CABG)

Key exclusion criteria (6 listed)

neurological or psychiatric disorders
alcohol or drug abuse
preoperative left ventricular ejection fraction of less than 30%
extracranial carotid artery stenosis of more than 70%
scoring below age- and education-adjusted cut-off values in Mini-Mental State Examination (MMSE)

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
exposure to type 2 neurological complicationsexposure to postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.	Other	type 2 neurological complications present

Primary outcome

Assessment of serum GFAP concentration (ng/ml) changes.
Time frame: GFAP concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of glial fibrillary acidic protein (GFAP).
Assessment of serum NSP concentration (ng/ml) changes.
Time frame: NSP concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of neuroserpin (NSP).
Assessment of serum pNfH concentration (ng/ml) changes.
Time frame: pNfH concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of neuroserpin phosphorylated axonal neurofilament subunit H (pNfH).
Assessment of serum VILIP-1 concentration (ng/ml) changes.
Time frame: VILIP-1 concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of visinin-like protein 1 (VILIP-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 5 Feb 2020.
Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from the corresponding author upon reasonable request.

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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.

Krzysztof Szwed, Dr principal investigator

Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum.

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 Neurological Complication of Procedure (Disorder), run by Collegium Medicum w Bydgoszczy at 1 site in Poland.

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 6 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 5 Feb 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 Poland. 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?

Assessment of serum GFAP concentration (ng/ml) changes. (time frame: GFAP concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03493256.

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 5 Feb 2020.