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

Unity Health Toronto

Status: Completed

Conditions: Aortic Aneurysm, Thoracic

Treatments: Procedure: Axillary artery cannulation; Procedure: Innominate artery cannulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02554032

15-071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Axillary artery cannulation

Active Comparator group

Description:

Axillary artery cannulation for antegrade cerebral perfusion

Treatment:

Procedure: Axillary artery cannulation

Innominate artery cannulation

Active Comparator group

Description:

Innominate artery cannulation for antegrade cerebral perfusion

Treatment:

Procedure: Innominate artery cannulation