Clinical trial NCT03607786: Antegrade Cerebral Perfusion and Retrograde Inferior Vena Caval Perfusion for Total Aortic Arch Replacement
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type A Aortic Dissection
Circulatory Arrest
Hypothermia
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite major complications
timeFrame: up to 12 months
Secondary outcomes:
measure: Respiratory Failure
timeFrame: up to 30 days
measure: Transient Neurological Deficit
timeFrame: up to 30 days
measure: Acute Kidney Injury not requiring Dialysis
timeFrame: up to 30 days
measure: Myocardial Infarction
timeFrame: up to 30 days
measure: Postoperative Prolonged Intubation
timeFrame: up to 30 days
measure: Paraparesis
timeFrame: up to 30 days
Other outcomes:
measure: The number of volume of blood products transfusion
timeFrame: up to 30 days
measure: Length of ICU stay
timeFrame: up to 30 days
measure: Length of postoperative stay
timeFrame: up to 30 days
measure: Gastrointestinal bleed
timeFrame: up to 30 days
measure: Postoperative ascites
timeFrame: up to 30 days
measure: Death
timeFrame: 12 months
measure: New onset dialysis (since incident surgery) status
timeFrame: 12 months
measure: Stroke
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 12 months
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Lei Du, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lin 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.