Antegrade Cerebral Perfusion and Retrograde Inferior Vena Caval Perfusion for Total Aortic Arch Replacement
CARTAR
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
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedApril 10, 2019
April 1, 2019
2.7 years
July 24, 2018
April 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Respiratory Failure
up to 30 days
Transient Neurological Deficit
up to 30 days
Acute Kidney Injury not requiring Dialysis
up to 30 days
Myocardial Infarction
up to 30 days
Postoperative Prolonged Intubation
up to 30 days
- +1 more secondary outcomes
Other Outcomes (9)
The number of volume of blood products transfusion
up to 30 days
Length of ICU stay
up to 30 days
Length of postoperative stay
up to 30 days
- +6 more other outcomes
Study Arms (2)
RIVP group
ACTIVE COMPARATORAfter 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.
ACP group
ACTIVE COMPARATORAfter 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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Patient aged 18 yr-65yr
- Patient underwent total aortic arch replacement
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Related Publications (2)
Lin J, Qin Z, Liu X, Xiong J, Wu Z, Guo Y, Kang D, Du L. Retrograde inferior vena caval perfusion for total aortic arch replacement surgery: a randomized pilot study. BMC Cardiovasc Disord. 2021 Apr 20;21(1):193. doi: 10.1186/s12872-021-02002-9.
PMID: 33879045DERIVEDLin J, Tan Z, Yao H, Hu X, Zhang D, Zhao Y, Xiong J, Dou B, Zhu X, Wu Z, Guo Y, Kang D, Du L. Retrograde Inferior Vena caval Perfusion for Total Aortic arch Replacement Surgery (RIVP-TARS): study protocol for a multicenter, randomized controlled trial. Trials. 2019 Apr 24;20(1):232. doi: 10.1186/s13063-019-3319-2.
PMID: 31014386DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lei Du, M.D
West China Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D
Study Record Dates
First Submitted
July 24, 2018
First Posted
July 31, 2018
Study Start
January 1, 2019
Primary Completion
September 30, 2021
Study Completion
September 30, 2022
Last Updated
April 10, 2019
Record last verified: 2019-04