Clinical trial NCT03074604: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Injury
Stroke
Postoperative Cognitive Dysfunction
Postoperative Delirium
Coronary Artery Disease
Coronary Artery Bypass Surgery
Off-Pump Coronary Artery Bypass
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
Lead sponsor: Collegium Medicum w Bydgoszczy
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 192
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* elective and/or urgent coronary artery bypass

Exclusion Criteria:

* 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
* 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)

Primary outcomes:
measure: New lesions on control brain magnetic resonance imaging.
timeFrame: 3 days after surgery
Secondary outcomes:
measure: New focal neurological deficits.
timeFrame: 7 days after surgery
measure: Occurence of postoperative cognitive dysfunction
timeFrame: 1 week or 3 months after surgery
measure: Incidence of delirium
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital
state: Kujawsko-Pomorskie
Study officials:
affiliation: Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland
name: Krzysztof Szwed, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland
name: Alina Borkowska, Professor
role: STUDY_CHAIR
References:
citation: 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.