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

A Randomized Controlled Trial of Axillary vs. Innominate Artery Cannulation for Antegrade Cerebral Protection in Aortic Surgery: The ACE Randomized Trial

Sponsors

Lead Sponsor: St. Michael's Hospital, Toronto

Collaborator: London Health Sciences Centre

Source St. Michael's Hospital, 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.

Overall Status Completed
Start Date June 2015
Completion Date July 2018
Primary Completion Date July 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
new severe ischemic lesions Post-operative day 4
Total operative time Intra-operative
Secondary Outcome
Measure Time Frame
all-cause mortality 30-day
Stroke or TIA (transient ischemic attack) 30-day
Neurocognitive dysfunction Post-operative day 4
Number of new ischemic lesions Post-operative day 4
Volume of new ischemic lesions Post-operative day 4
Intracerebral hemorrhage Post-operative day 4
S100B and Neuron Specific Enolase 24 hours post-op
Post-operative sepsis, delirium, seizure, encephalopathy, atrial fibrillation, post-operative myocardial infarction, re-operation 30-day
Seroma, brachial plexus injury, reduced arm mobility and pain, arm ischemia 30-day
Enrollment 110
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Axillary artery cannulation

Description: The right axillary artery will be exposed via an infraclavicular incision and a Dacron graft sewn to it in an end to side fashion after 5000 units of IV heparin. Following median sternotomy and full systemic heparinization, CPB will be initiated and the patient cooled. The base of the innominate artery will be clamped, and antegrade cerebral perfusion will be provided via the axillary artery. Following completion of the distal open aortic anastomosis, the clamp on the innominate artery will be removed, CPB via the aorta will be resumed and the patient will be rewarmed. After completion of surgery and weaning from CPB, the axillary artery graft will then be removed, the artery repaired and the skin will be closed.

Arm Group Label: Axillary artery cannulation

Intervention Type: Procedure

Intervention Name: Innominate artery cannulation

Description: After median sternotomy, systemic heparinization, cannulation of the ascending aorta and right atrium, CPB and systemic cooling will be initiated. The ascending aorta, proximal arch and the base of the innominate artery will be mobilized. Purse-string sutures are placed on the anterior wall of the proximal innominate artery and a pediatric venous cannula inserted using a J wire and sequential dilatation. Circulatory arrest with ACP is provided by clamping the base of the innominate artery and connecting the afferent limb of the CPB circuit to the innominate cannula. Once the distal aortic anastomosis is completed, ACP is discontinued, and full CPB via the aortic graft is resumed. Rewarming and the remaining surgery are then completed.

Arm Group Label: Innominate artery cannulation

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
David Mazer, MD Principal Investigator St. Michael's Hospital, Toronto
Location
Facility:
London Health Sciences Centre | London, Ontario, N6A 5W9, Canada
St Michael's Hospital | Toronto, Ontario, M5B1W8, Canada
Location Countries

Canada

Verification Date

September 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Axillary artery cannulation

Type: Active Comparator

Description: Axillary artery cannulation for antegrade cerebral perfusion

Label: Innominate artery cannulation

Type: Active Comparator

Description: Innominate artery cannulation for antegrade cerebral perfusion

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov