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

Aortic Aneurysm, Thoracic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554032
• Other study ID #: 15-071
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: July 2018

Study information

• Verified date: September 2018
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic

Intervention

Procedure:
• Axillary artery cannulation
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.
• Innominate artery cannulation
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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	St Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	London Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerebral oximetry desaturation		intra-operative
Other	CPB (cardiopulmonary bypass) time		intra-operative
Other	Deep hypothermic circulatory arrest time		intra-operative
Other	Antegrade cerebral perfusion time		intra-operative
Primary	new severe ischemic lesions	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.	Post-operative day 4
Primary	Total operative time	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.	Intra-operative
Secondary	all-cause mortality		30-day
Secondary	Stroke or TIA (transient ischemic attack)		30-day
Secondary	Neurocognitive dysfunction	Montreal Cognitive Assessment (MOCA) and Mini-Mental State Examination (MMSE)	Post-operative day 4
Secondary	Number of new ischemic lesions	assessed by DW-MRI	Post-operative day 4
Secondary	Volume of new ischemic lesions	assessed by DW-MRI	Post-operative day 4
Secondary	Intracerebral hemorrhage	assessed by DW-MRI	Post-operative day 4
Secondary	S100B and Neuron Specific Enolase	Post-operative serum level of circulating biomarkers of neuronal injury	24 hours post-op
Secondary	Post-operative sepsis, delirium, seizure, encephalopathy, atrial fibrillation, post-operative myocardial infarction, re-operation		30-day
Secondary	Seroma, brachial plexus injury, reduced arm mobility and pain, arm ischemia		30-day