Clinical trial NCT02554032: The Aortic Surgery Cerebral Protection Evaluation (ACE) Randomized CardioLink-3 Trial
Official title: A Randomized Controlled Trial of Axillary vs. Innominate Artery Cannulation for Antegrade Cerebral Protection in Aortic Surgery: The ACE Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm, Thoracic
Keywords: antegrade cerebral perfusion
innominate artery cannulation
axillary artery cannulation
aortic surgery
deep hypothermic circulatory arrest
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre
First posted: 2015-09-18
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The ACE trial is a multicentre, randomized controlled trial comparing axillary vs. innominate artery cannulation for established antegrade cerebral perfusion in patients having aortic surgery (thoracic and aortic arch) requiring deep hypothermic circulatory arrest using a non-inferiority trial design.

Detailed description: Surgery on the thoracic aorta often requires a brief period of deep hypothermic circulatory arrest (DHCA). The most feared complication of aortic surgery is neurological injury, which can range from mild cognitive impairment to more severe injuries such as stroke. Due to the significant morbidity and mortality associated with post-operative stroke and neurological dysfunction, cerebral protection techniques have evolved extensively. A recommended approach to cerebral protection during DHCA is to deliver blood to the brain in an antegrade fashion via the arterial system, so called antegrade cerebral perfusion (ACP). Axillary artery cannulation, a form of ACP, has become the preferred method of neuroprotection for aortic operations requiring DHCA. However, axillary artery cannulation requires more surgical time and presents potential complications such as brachial plexus injury, seromas, and limb ischemia. The present study aims to determine whether a less common alternative strategy, innominate artery cannulation, offers similar neuroprotection compared to axillary artery cannulation and reduces operative times. A total of 110 patients undergoing elective aortic surgery will be randomly assigned to one of the two strategies. The primary outcome will be the number of patients with new ischemic lesions found on post-operative diffusion weighted MRI (DW-MRI) and total operative time.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
2. Elective aortic arch operation.
3. Planned open distal anastamosis with deep hypothermic circulatory arrest.

Exclusion Criteria:

1. Patients undergoing surgery for aortic dissection or urgent/emergent operation.
2. Patients undergoing surgery for total aortic arch replacement.
3. Patients who are unable to undergo MRI scan (such as due to claustrophobia).
4. Use of an investigational drug or device at the time of enrolment
5. Participation in another clinical trial which interferes with performance of the study procedures or assessment of the outcomes

Primary outcomes:
measure: new severe ischemic lesions
timeFrame: Post-operative day 4
measure: Total operative time
timeFrame: Intra-operative
Secondary outcomes:
measure: all-cause mortality
timeFrame: 30-day
measure: Stroke or TIA (transient ischemic attack)
timeFrame: 30-day
measure: Neurocognitive dysfunction
timeFrame: Post-operative day 4
measure: Number of new ischemic lesions
timeFrame: Post-operative day 4
measure: Volume of new ischemic lesions
timeFrame: Post-operative day 4
measure: Intracerebral hemorrhage
timeFrame: Post-operative day 4
measure: S100B and Neuron Specific Enolase
timeFrame: 24 hours post-op
measure: Post-operative sepsis, delirium, seizure, encephalopathy, atrial fibrillation, post-operative myocardial infarction, re-operation
timeFrame: 30-day
measure: Seroma, brachial plexus injury, reduced arm mobility and pain, arm ischemia
timeFrame: 30-day
Other outcomes:
measure: Cerebral oximetry desaturation
timeFrame: intra-operative
measure: CPB (cardiopulmonary bypass) time
timeFrame: intra-operative
measure: Deep hypothermic circulatory arrest time
timeFrame: intra-operative
measure: Antegrade cerebral perfusion time
timeFrame: intra-operative
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: David Mazer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen CH, Peterson MD, Mazer CD, Hibino M, Beaudin AE, Chu MWA, Dagenais F, Teoh H, Quan A, Dickson J, Verma S, Smith EE. Acute Infarcts on Brain MRI Following Aortic Arch Repair With Circulatory Arrest: Insights From the ACE CardioLink-3 Randomized Trial. Stroke. 2023 Jan;54(1):67-77. doi: 10.1161/STROKEAHA.122.041612. Epub 2022 Oct 31.
citation: Peterson MD, Garg V, Mazer CD, Chu MWA, Bozinovski J, Dagenais F, MacArthur RGG, Ouzounian M, Quan A, Juni P, Bhatt DL, Marotta TR, Dickson J, Teoh H, Zuo F, Smith EE, Verma S; ACE CardioLink-3 Trial Working Group. A randomized trial comparing axillary versus innominate artery cannulation for aortic arch surgery. J Thorac Cardiovasc Surg. 2022 Nov;164(5):1426-1438.e2. doi: 10.1016/j.jtcvs.2020.10.152. Epub 2020 Dec 1.
citation: Garg V, Peterson MD, Chu MW, Ouzounian M, MacArthur RG, Bozinovski J, El-Hamamsy I, Victor Chu F, Garg A, Hall J, Thorpe KE, Dhingra N, Teoh H, Marotta TR, Latter DA, Quan A, Mamdani M, Juni P, David Mazer C, Verma S. Axillary versus innominate artery cannulation for antegrade cerebral perfusion in aortic surgery: design of the Aortic Surgery Cerebral Protection Evaluation (ACE) CardioLink-3 randomised trial. BMJ Open. 2017 Jun 10;7(6):e014491. doi: 10.1136/bmjopen-2016-014491.