Neurological InjuryCANONNCT03074604
Carbon Dioxide Surgical Field Flooding and Aortic No-touch Off-pump Coronary Artery Bypass Grafting to Reduce Neurological Injuries After Surgical Coronary Revascularization (CANON): a Randomised, Controlled, Investigator and Patient Blinded Single Center Superiority Trial With Three Parallel Arms.
A study testing aortic no-touch OPCABG, OPCABG with partial clamp applying carbon dioxide and OPCABG with partial clamp in people with Neurological Injury and Stroke, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
Trial summary
The objective of this study is to investigate the value of employing the aortic no-touch off-pump coronary artery bypass technique and the practice of carbon dioxide surgical field flooding for the prevention of type 1 and 2 neurological injuries following surgical coronary revascularization. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Neurological Injury, Stroke, Postoperative Cognitive Dysfunction
- What is being tested?
- aortic no-touch OPCABG, OPCABG with partial clamp applying carbon dioxide and OPCABG with partial clamp
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 sitePoland
- Study dates
- 28 Feb 2017to 1 Jul 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective and/or urgent coronary artery bypass
Who cannot join
- emergent and salvage setting
- score below age- and education-adjusted cut-off scores in mini mental state examination
- score above 8 on the subscales of hospital anxiety and depression scale
- neurologic deficit of any etiology
- previous psychiatric illness
- use of tranquilizers or antipsychotics
Show all 12Show fewer
- alcohol or drug abuse
- history of cardiac surgery
- left ventricular ejection fraction less than 30%
- extracranial carotid artery stenosis of more than 70%
- body mass index of more than 35 kg/m2
- any contraindication for magnetic resonance imaging (e.g., magnetic resonance imaging - incompatible implantable device and claustrophobia)
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, 85-001
About this study
The objective of this study is to investigate the value of employing the aortic no-touch off-pump coronary artery bypass technique and the practice of carbon dioxide surgical field flooding for the prevention of type 1 and 2 neurological injuries following surgical coronary revascularization.
Read the detailed description
Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offset survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue, is off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques.
In this randomised, controlled, investigator and patient blinded single center superiority trial with three parallel arms a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment and one control arms. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with a partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG. The primary endpoint will be the appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis.
- Conditions
- Neurological Injury, Stroke, Postoperative Cognitive Dysfunction, Postoperative Delirium, Coronary Artery Disease, Coronary Artery Bypass Surgery
- Being tested
- aortic no-touch OPCABG, OPCABG with partial clamp applying carbon dioxide, OPCABG with partial clamp
- Keywords
- Brain Injuries, Neurological Injury, Stroke, Postoperative Cognitive Dysfunction, Postoperative Delirium, Coronary Artery Disease, Coronary Artery Bypass Grafting, Coronary Artery Bypass Surgery, Bypass surgery, Beating Heart Coronary Artery Bypass, Off-Pump Coronary Artery Bypass
- Medical subject headings
- Trauma, Nervous System, Stroke, Postoperative Cognitive Complications, Emergence Delirium, Coronary Artery Disease, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aortic no-touch OPCABGProcedure or surgery
(Study arm 1) In this intervention only the internal mammary artery grafts will be used (i.e. left internal mammary artery graft, right internal mammary artery graft, or a Y-graft that uses right internal mammary artery graft anastomosed onto left internal mammary artery graft to allow for a wide territory of myocardial revascularization). However, in the rare event that the aforementioned approach is insufficient to reach all target vessels, a reversed (great) saphenous vein graft may be used to extend the left internal mammary artery graft or the right internal mammary artery graft.
OPCABG with partial clamp applying carbon dioxideProcedure or surgery
(Study arm 2) In this intervention chest cavity will be insufflated with carbon dioxide at a flow above 5 l/min during the entire surgical procedure.
OPCABG with partial clampProcedure or surgery
(Study arm 3) This is the control arm undergoing "traditional" OPCABG with partial clamp.
| Study group | Role | What they receive |
|---|---|---|
| aortic no-touch OPCABG | Experimental | aortic no-touch OPCABG Receives: Procedure: aortic no-touch OPCABG |
| OPCABG with partial clamp applying carbon dioxide | Experimental | OPCABG with partial clamp applying carbon dioxide Receives: Procedure: OPCABG with partial clamp applying carbon dioxide |
| OPCABG with partial clamp | Active comparator | OPCABG with partial clamp Receives: Procedure: OPCABG with partial clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
New lesions on control brain magnetic resonance imaging.
Appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery.
Measured: 3 days after surgery
Secondary outcomes (3)
New focal neurological deficits.
Prevalence of new focal neurological deficits in the first 7 days after surgery.
Measured: 7 days after surgery
Occurence of postoperative cognitive dysfunction
Occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery
Measured: 1 week or 3 months after surgery
Incidence of delirium
Incidence of delirium in the first 7 days after surgery.
Measured: 7 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 posted9 Mar 2017
- Study start28 Feb 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurological InjuryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The CANON trial is designed as a randomised, controlled, investigator and patient blinded single center superiority trial with three parallel arms and a primary endpoint being the appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collegium Medicum w Bydgoszczy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krzysztof Szwed, Collegium Medicum w Bydgoszczy
- Investigators
- Krzysztof Szwed, M.D. Ph.D., Principal investigator, Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, PolandAlina Borkowska, Professor, Study chair, Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074604
- Sponsor's protocol ID
- KB 60/2017
- Acronym
- CANON
- Status last verified
- Feb 2020
- First submitted
- 28 Feb 2017
- 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.
Publications
Krzysztof S, Wojciech P, Zbigniew S, Mariusz K, Remigiusz T, Damian P, Magdalena S, Marta T, Lech A, Alina B. CArbon dioxide surgical field flooding and aortic NO-touch off-pump coronary artery bypass grafting to reduce Neurological injuries after surgical coronary revascularisation (CANON): protocol for a randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms. BMJ Open. 2017 Jul 10;7(7):e016785. doi: 10.1136/bmjopen-2017-016785.
PubMed 28698347
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
- Carbon Dioxide Surgical Field Flooding and Aortic No-touch Off-pump Coronary Artery Bypass Grafting to Reduce Neurological Injuries After Surgical Coronary Revascularization (CANON): a Randomised, Controlled, Investigator and Patient Blinded Single Center Superiority Trial With Three Parallel Arms.
- ClinicalTrials.gov ID
- NCT03074604
- Acronym / sponsor ID
- CANON / KB 60/2017
- Conditions
- Neurological Injury, Stroke, Postoperative Cognitive Dysfunction, Postoperative Delirium, Coronary Artery Disease, Coronary Artery Bypass Surgery
- Keywords
- Brain Injuries, Neurological Injury, Stroke, Postoperative Cognitive Dysfunction, Postoperative Delirium, Coronary Artery Disease, Coronary Artery Bypass Grafting, Coronary Artery Bypass Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Collegium Medicum w BydgoszczyUniversity, hospital or other
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 9 Mar 2017 (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.
The objective of this study is to investigate the value of employing the aortic no-touch off-pump coronary artery bypass technique and the practice of carbon dioxide surgical field flooding for the prevention of type 1 and 2 neurological injuries following surgical coronary revascularization.
Detailed description
Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offset survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue, is off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques.
In this randomised, controlled, investigator and patient blinded single center superiority trial with three parallel arms a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment and one control arms. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with a partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG. The primary endpoint will be the appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The CANON trial is designed as a randomised, controlled, investigator and patient blinded single center superiority trial with three parallel arms and a primary endpoint being the appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery.
| Arm | Type | Receives |
|---|---|---|
| aortic no-touch OPCABG | Experimental | Procedure: aortic no-touch OPCABGaortic no-touch OPCABG |
| OPCABG with partial clamp applying carbon dioxide | Experimental | Procedure: OPCABG with partial clamp applying carbon dioxideOPCABG with partial clamp applying carbon dioxide |
| OPCABG with partial clamp | Active comparator | Procedure: OPCABG with partial clampOPCABG with partial clamp |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective and/or urgent coronary artery bypass
Key exclusion criteria (12 listed)
- emergent and salvage setting
- score below age- and education-adjusted cut-off scores in mini mental state examination
- score above 8 on the subscales of hospital anxiety and depression scale
- neurologic deficit of any etiology
- previous psychiatric illness
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 |
|---|---|---|
| aortic no-touch OPCABG(Study arm 1) In this intervention only the internal mammary artery grafts will be used (i.e. left internal mammary artery graft, right internal mammary artery graft, or a Y-graft that uses right internal mammary artery graft anastomosed onto left internal mammary artery graft to allow for a wide territory of myocardial revascularization). However, in the rare event that the aforementioned approach is insufficient to reach all target vessels, a reversed (great) saphenous vein graft may be used to extend the left internal mammary artery graft or the right internal mammary artery graft. | Procedure or surgery | aortic no-touch OPCABG |
| OPCABG with partial clamp applying carbon dioxide(Study arm 2) In this intervention chest cavity will be insufflated with carbon dioxide at a flow above 5 l/min during the entire surgical procedure. | Procedure or surgery | OPCABG with partial clamp applying carbon dioxide |
| OPCABG with partial clamp(Study arm 3) This is the control arm undergoing "traditional" OPCABG with partial clamp. | Procedure or surgery | OPCABG with partial clamp |
Primary outcome
New lesions on control brain magnetic resonance imaging.
Time frame: 3 days after surgery
Appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery.
3 secondary outcomes
New focal neurological deficits.
Time frame: 7 days after surgery
Occurence of postoperative cognitive dysfunction
Time frame: 1 week or 3 months after surgery
Incidence of delirium
Time frame: 7 days after surgery
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.
- Derived from this study: PubMed 28698347Krzysztof S, Wojciech P, Zbigniew S, Mariusz K, Remigiusz T, Damian P, Magdalena S, Marta T, Lech A, Alina B. CArbon dioxide surgical field flooding and aortic NO-touch off-pump coronary artery bypass grafting to reduce Neurological injuries after surgical coronary revascularisation (CANON): protocol for a randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms. BMJ Open. 2017 Jul 10;7(7):e016785. doi: 10.1136/bmjopen-2017-016785.
- 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, M.D. Ph.D. principal investigator
Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland
Alina Borkowska, Professor study chair
Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aortic no-touch OPCABG, OPCABG with partial clamp applying carbon dioxide and OPCABG with partial clamp in people with Neurological Injury and Stroke, 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 12 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?
New lesions on control brain magnetic resonance imaging. (time frame: 3 days after surgery). 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 NCT03074604, which also lists 1 linked publication.
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.