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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
This 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.
This 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.
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
RECRUITINGMajor 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 operation
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 days
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.
Early Mortality
Death occurring after discharge or within 1 year of follow-up
Time frame: Postoperative 6 to 12 months
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