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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02554032
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
London Health Sciences Centre
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Thoracic Procedure: Axillary artery cannulation Procedure: Innominate artery cannulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of Axillary vs. Innominate Artery Cannulation for Antegrade Cerebral Protection in Aortic Surgery: The ACE Randomized Trial
Study Start Date : June 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Axillary artery cannulation
Axillary artery cannulation for antegrade cerebral perfusion
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.

Active Comparator: Innominate artery cannulation
Innominate artery cannulation for antegrade cerebral perfusion
Procedure: 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.




Primary Outcome Measures :
  1. new severe ischemic lesions [ Time Frame: 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.

  2. Total operative time [ Time Frame: 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 :
  1. all-cause mortality [ Time Frame: 30-day ]
  2. Stroke or TIA (transient ischemic attack) [ Time Frame: 30-day ]
  3. Neurocognitive dysfunction [ Time Frame: Post-operative day 4 ]
    Montreal Cognitive Assessment (MOCA) and Mini-Mental State Examination (MMSE)

  4. Number of new ischemic lesions [ Time Frame: Post-operative day 4 ]
    assessed by DW-MRI

  5. Volume of new ischemic lesions [ Time Frame: Post-operative day 4 ]
    assessed by DW-MRI

  6. Intracerebral hemorrhage [ Time Frame: Post-operative day 4 ]
    assessed by DW-MRI

  7. S100B and Neuron Specific Enolase [ Time Frame: 24 hours post-op ]
    Post-operative serum level of circulating biomarkers of neuronal injury

  8. Post-operative sepsis, delirium, seizure, encephalopathy, atrial fibrillation, post-operative myocardial infarction, re-operation [ Time Frame: 30-day ]
  9. Seroma, brachial plexus injury, reduced arm mobility and pain, arm ischemia [ Time Frame: 30-day ]

Other Outcome Measures:
  1. Cerebral oximetry desaturation [ Time Frame: intra-operative ]
  2. CPB (cardiopulmonary bypass) time [ Time Frame: intra-operative ]
  3. Deep hypothermic circulatory arrest time [ Time Frame: intra-operative ]
  4. Antegrade cerebral perfusion time [ Time Frame: intra-operative ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554032


Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
St Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Sponsors and Collaborators
Unity Health Toronto
London Health Sciences Centre
Investigators
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Principal Investigator: David Mazer, MD Unity Health Toronto
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT02554032    
Other Study ID Numbers: 15-071
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Keywords provided by Unity Health Toronto:
antegrade cerebral perfusion
innominate artery cannulation
axillary artery cannulation
aortic surgery
deep hypothermic circulatory arrest
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases