The Aortic Surgery Cerebral Protection Evaluation (ACE) Randomized CardioLink-3 Trial

Not Applicable

Completed

• Conditions: Aortic Aneurysm, Thoracic
• Interventions: Procedure: Innominate artery cannulation; Procedure: Axillary artery cannulation

• Registration Number: NCT02554032
• Lead Sponsor: Unity Health Toronto

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-11
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Innominate artery cannulation	Innominate artery cannulation	Innominate artery cannulation for antegrade cerebral perfusion
Axillary artery cannulation	Axillary artery cannulation	Axillary artery cannulation for antegrade cerebral perfusion

Primary Outcome Measures

Name	Time	Method
new severe ischemic lesions	Post-operative day 4	The primary safety endpoint of this trial is the proportion of patients with new severe ischemic lesions found on post-operative DW-MRI compared with pre-operative MRI.
Total operative time	Intra-operative	The primary efficacy endpoint of this trial is the difference in total operative time between the innominate artery cannulation group and the axillary artery cannulation group.

Secondary Outcome Measures

Name	Time	Method
Seroma, brachial plexus injury, reduced arm mobility and pain, arm ischemia	30-day
Stroke or TIA (transient ischemic attack)	30-day
Volume of new ischemic lesions	Post-operative day 4	assessed by DW-MRI
Intracerebral hemorrhage	Post-operative day 4	assessed by DW-MRI
Post-operative sepsis, delirium, seizure, encephalopathy, atrial fibrillation, post-operative myocardial infarction, re-operation	30-day
all-cause mortality	30-day
Number of new ischemic lesions	Post-operative day 4	assessed by DW-MRI
S100B and Neuron Specific Enolase	24 hours post-op	Post-operative serum level of circulating biomarkers of neuronal injury
Neurocognitive dysfunction	Post-operative day 4	Montreal Cognitive Assessment (MOCA) and Mini-Mental State Examination (MMSE)

Trial Locations

Locations (2)

St Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada