A Randomized Controlled Trial of Axillary vs. Innominate Artery Cannulation for Antegrade Cerebral Protection in Aortic Surgery: The ACE Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- new severe ischemic lesions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Elective aortic arch operation.
- •Planned open distal anastamosis with deep hypothermic circulatory arrest.
排除标准
- •Patients undergoing surgery for aortic dissection or urgent/emergent operation.
- •Patients undergoing surgery for total aortic arch replacement.
- •Patients who are unable to undergo MRI scan (such as due to claustrophobia).
- •Use of an investigational drug or device at the time of enrolment
- •Participation in another clinical trial which interferes with performance of the study procedures or assessment of the outcomes
研究组 & 干预措施
Axillary artery cannulation
Axillary artery cannulation for antegrade cerebral perfusion
干预措施: Axillary artery cannulation (Procedure)
Innominate artery cannulation
Innominate artery cannulation for antegrade cerebral perfusion
干预措施: Innominate artery cannulation (Procedure)
结局指标
主要结局
new severe ischemic lesions
时间窗: 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
时间窗: 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.
次要结局
- Stroke or TIA (transient ischemic attack)(30-day)
- Volume of new ischemic lesions(Post-operative day 4)
- Seroma, brachial plexus injury, reduced arm mobility and pain, arm ischemia(30-day)
- Intracerebral hemorrhage(Post-operative day 4)
- Post-operative sepsis, delirium, seizure, encephalopathy, atrial fibrillation, post-operative myocardial infarction, re-operation(30-day)
- all-cause mortality(30-day)
- Number of new ischemic lesions(Post-operative day 4)
- S100B and Neuron Specific Enolase(24 hours post-op)
- Neurocognitive dysfunction(Post-operative day 4)