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

Not Applicable

• Conditions: Type A Aortic Dissection; Hypothermia; Circulatory Arrest
• Interventions: Procedure: Select antegrade cerebral perfusion; Procedure: Retrograde Inferior Vena Caval Perfusion

• Registration Number: NCT03607786
• Lead Sponsor: West China Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-07-31
• Study Start: 2019-01-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10
• Primary Completion: 2021-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Patient aged 18 yr-65yr
2. Patient underwent total aortic arch replacement

Exclusion Criteria

1. Inability to understand/give informed consent,
2. Participation in another clinical trial that interferes with the primary or secondary outcomes of this trial.
3. Inability to obtain superior and inferior vena caval cannulation due to pericardium adhesion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACP group	Select antegrade cerebral perfusion	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.
RIVP group	Retrograde Inferior Vena Caval Perfusion	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Respiratory Failure	up to 30 days
Transient Neurological Deficit	up to 30 days	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.
Acute Kidney Injury not requiring Dialysis	up to 30 days	Kidney Disease Improving Global Outcomes (KDIGO) guidelines17
Myocardial Infarction	up to 30 days
Postoperative Prolonged Intubation	up to 30 days	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
Paraparesis	up to 30 days	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)

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China