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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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 from two centres 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.
Sponsor: St. Michael's Hospital, Toronto

Current Primary Outcome:

  • 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.
  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: St. Michael's Hospital, Toronto

Dates:
Date Received: June 10, 2015
Date Started: June 2015
Date Completion: June 2017
Last Updated: June 9, 2016
Last Verified: June 2016