Antegrade Cerebral Perfusion and Retrograde Inferior Vena Caval Perfusion for Total Aortic Arch Replacement
NCT03607786 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2019-04-10
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.
Conditions
- Type A Aortic Dissection
- Circulatory Arrest
- Hypothermia
Interventions
- PROCEDURE
-
Retrograde Inferior Vena Caval Perfusion
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.
- PROCEDURE
-
Select antegrade cerebral perfusion
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
Sponsors & Collaborators
-
West China Hospital
lead OTHER
Principal Investigators
-
Lei Du, M.D · West China Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-01
- Primary Completion
- 2021-09-30
- Completion
- 2022-09-30
Countries
- China
Study Locations
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