CompaRison of FEmorofemoral Bypass and Left-Heart ByPass Techniques in Open Thoracoabdominal AortIc Aneurysm Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital
About this trial
The study is a multicenter, two-arm, open-label, randomized, parallel-controlled trial, which plans to enroll 236 participants diagnosed with TAAA from 4 hospitals in China. All patients receive TAAAR procedure and are randomized to control group (LHB) and experimental group (fCPB) in the ratio of 1:1. After a 1-year follow-up, the validity and safety of the different cardiopulmonary bypass for TAAAR is evaluated via the incidence of major adverse events including surgical mortality, RRT, stroke, and SCI, as well as intraoperative blood product transfusion volume, mechanical ventilation, and early mortality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Computed tomography angiography (CTA) confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;
Adult patients (≥18 years old);
Indications for TAAAR are available and requiring cardiopulmonary bypass;
Signed informed consent and availability for follow-up.
Disqualifiers
History of chronic renal failure, chronic heart failure, Coronary heart disease with established surgical indications, hepatocirrhosis, and hepatic insufficiency;
History of severe cerebral infarction (with cerebral infarction sequels);
Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;
History of infectious aortic diseases;
Trial design
Design model
Parallel
Treatments tested in this trial
Thoracoabdominal aortic aneurysm repair under fCPB
Procedure/SurgeryThis procedure is performed under fCPB via femoral artery and vein, inferior vena cava outside the pericardial cavity is alternative choice. Two clamps were used to occlude the distal aortic arch beyond the left subclavian artery and the proximal descending aorta at the same time. A triple occlusion technique could also be adopted when the aneurysm neck was located high. The proximal abdominal aorta was clamped at the diaphragmatic level after the proximal anastomosis was completed, then intercostal artery reconstruction was performed using the arterial tube method. The clamp is deployed at the bilateral iliac bifurcation, the branches of the four-branched graft were anastomosed sequentially in the order of the right renal artery, superior mesenteric artery, celiac trunk, and left renal artery. Finally, the distal end of the four-branched graft was anastomosed to the distal abdominal aorta.
Thoracoabdominal aortic aneurysm repair under LHB
Procedure/SurgeryThis procedure is performed under LHB via the left inferior pulmonary vein and femoral artery. Two clamps were used to occlude the distal aortic arch beyond the left subclavian artery and the proximal descending aorta at the same time. A triple occlusion technique could also be adopted when the aneurysm neck was located high. The proximal abdominal aorta was clamped at the diaphragmatic level after the proximal anastomosis was completed, then intercostal artery reconstruction was performed using the arterial tube method. The clamp is deployed at the bilateral iliac bifurcation, the branches of the four-branched graft were anastomosed sequentially in the order of the right renal artery, superior mesenteric artery, celiac trunk, and left renal artery. Finally, the distal end of the four-branched graft was anastomosed to the distal abdominal aorta.
Treatment groups
236 Participants
are divided into 2 treatment groupsGroup A: femoro-femoral cardiopulmonary bypassExperimental treatment 1 intervention
Group B: left heart bypassActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Major adverse events
Major adverse events include surgical mortality, renal replacement treatment, stroke, and spinal cord injury.
Time frame
Thirty days and 12 months after the operationSecondary outcomes
1
Blood Product Transfusion Volume
volume of blood products transfused from surgical day to postoperative 3 day, including red blood cells, fresh frozen plasma, apheresis platelets and recombinant activated coagulation factor VII
Time frame
Surgical day and postoperative 1 to 3 days2
Duration of Mechanical Ventilation
time interval between mechanical ventilation and extubation after operation.
Time frame
Surgical day, postoperative 1 to 3 days, and discharge day / postoperative 30 days.3
Early Mortality
Death occurring after discharge or within 1 year of follow-up
Time frame
Postoperative 6 to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Anzhen Hospital
Lead sponsor
Xiangya Hospital of Central South University
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Guangzhou First People's Hospital
Collaborator
Source ClinicalTrials.gov