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

Sichuan University

Status: Unknown

Conditions: Circulatory Arrest; Type A Aortic Dissection; Hypothermia

Treatments: Procedure: Retrograde Inferior Vena Caval Perfusion; Procedure: Select antegrade cerebral perfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03607786

WCH-2018-24

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 2 patient groups

RIVP group

Active Comparator group

Description:

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.

Treatment:

Procedure: Retrograde Inferior Vena Caval Perfusion

ACP group

Active Comparator group

Description:

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.

Treatment:

Procedure: Select antegrade cerebral perfusion