Antegrade Cerebral Perfusion and Retrograde Inferior Vena Caval Perfusion for Total Aortic Arch Replacement

Study Overview
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Brief Summary
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This study is designed as a multicenter, randomized, assessor- blinded clinical trial.The primary aim of this trial is to assess whether retrograde inferior venal caval perfusion combined selective antegrade cerebral perfusion(ACP)under mild hypothermia, compared with moderate hypothermia combined with selective ACP alone, improves the outcome for the patients undergoing total aortic arch replacement.

Official Title
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The Effect of Combination of Selective Antegrade Cerebral Perfusion With Retrograde Inferior Vena Caval Perfusion on the Outcomes in Patients Underwent Total Aortic Arch Replacement

Conditions
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Type A Aortic Dissection, Circulatory Arrest, Hypothermia

Intervention / Treatment
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* Procedure: Retrograde Inferior Vena Caval Perfusion
* Procedure: Select antegrade cerebral perfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 18 yr-65yr Patient underwent total aortic arch replacement Exclusion Criteria: Inability to understand/give informed consent, Participation in another clinical trial that interferes with the primary or secondary outcomes of this trial. Inability to obtain superior and inferior vena caval cannulation due to pericardium adhesion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RIVP group<br>After total cardiopulmonary bypass was initiated, the patient is cooled slowly to induce moderate hypothermia(28-30℃). The combination of selective antegrade cerebral perfusion and retrograde inferior vena caval perfusion is performed. The antegrade perfusion flow rate was is maintained at 6-12 mL/min/kg.Pump pressure of retrograde perfusion was is maintained at 20-30 mmHg, and blood flow was is maintained at 8-12 mL/min/kg. | Procedure: Retrograde Inferior Vena Caval Perfusion<br>* Retrograde Inferior Vena Caval Perfusion is achieved by tethering the inferior vena cava with a band around the cannula and by clamping the distal end of the inferior vena cava drainage tube, which allowed a pump to drive oxygenated blood into the inferior vena cava. Pump pressure is maintained at 20-30 mmHg, and blood flow is maintained at 8-12 mL/min/kg. The aim of RIVP is to maintain the lower body perfusion during circulation arrest, and reduce the ischemia-associated vital organ injury.<br>* Other names: Select antegrade cerebral perfusion;|
| Active Comparator: ACP group<br>After total cardiopulmonary bypass was initiated, the patient is cooled slowly to induce moderate hypothermia(26-28℃). Only select antegrade cerebral perfusion is performed by maintaining the flow rate at 6-12 mL/min/kg. | Procedure: Select antegrade cerebral perfusion<br>* Antegrade cerebral perfusion is achieved using a 12 F cannula inserted into the brachiocephalic artery or right axillary artery. The antegrade perfusion flow rate is maintained at 6-12 mL/min/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite major complications | Newly Postoperative Renal Failure;Surgical Re-exploration；Operative Mortality;Deep Sternal Wound Infection;Stroke/Cerebrovascular Accident;Paraplegia | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Failure |  | up to 30 days | 
| Transient Neurological Deficit | The occurrence of postoperative agitation, confusion, delirium, obtundation or a transient focal neurologic deficit (resolution within 72 hours) without any evidence of new structural abnormality on computed tomography or magnetic resonance imaging. | up to 30 days | 
| Acute Kidney Injury not requiring Dialysis | Kidney Disease Improving Global Outcomes (KDIGO) guidelines17 | up to 30 days | 
| Myocardial Infarction |  | up to 30 days | 
| Postoperative Prolonged Intubation | patients aged 18 years and older who require intubation for more than 24 hours patients aged 18 years and older undergoing isolated CABG who require intubation for more than 24 hours patients aged 18 years and older undergoing isolated CABG who require intubation for more than 24 hours patients aged 18 years and older undergoing isolated CABG who require intubation for more than 24 hours Patients who require intubation for more than 24 hours | up to 30 days | 
| Paraparesis | Motor weakness in any lower extremity muscle group or unilateral paraplegia (Tarlov score 1-4 or, if present, a score of zero in a single lower extremity) | up to 30 days |