Cardiopulmonary Bypass, Open Repair, Thoracoabdominal Aortic Aneurysm
Conditions
Brief summary
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.
Interventions
PROCEDUREThoracoabdominal aortic aneurysm repair under fCPB
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.
PROCEDUREThoracoabdominal aortic aneurysm repair under LHB
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.
Sponsors
Beijing Anzhen Hospital
Xiangya Hospital of Central South University
Guangdong Provincial People's Hospital
Guangzhou First People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study is a multicenter, two-arm, open-label, randomized, parallel-controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Computed tomography angiography (CTA) confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease; 2. Adult patients (≥18 years old); 3. Indications for TAAAR are available and requiring cardiopulmonary bypass; 4. Signed informed consent and availability for follow-up.
Exclusion criteria
1. History of chronic renal failure, chronic heart failure, Coronary heart disease with established surgical indications, hepatocirrhosis, and hepatic insufficiency; 2. History of severe cerebral infarction (with cerebral infarction sequels); 3. Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc; 4. History of infectious aortic diseases; 5. History of malignancy or previous radiotherapy; 6. Pregnant or feeding women, or anyone planning to reproduce during the test period; 7. Participating in any other clinical trial; 8. Having other causes not eligible for operation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse events | Thirty days and 12 months after the operation | Major adverse events include surgical mortality, renal replacement treatment, stroke, and spinal cord injury. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Product Transfusion Volume | Surgical day and postoperative 1 to 3 days | 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 |
| Duration of Mechanical Ventilation | Surgical day, postoperative 1 to 3 days, and discharge day / postoperative 30 days. | time interval between mechanical ventilation and extubation after operation. |
| Early Mortality | Postoperative 6 to 12 months | Death occurring after discharge or within 1 year of follow-up |
Countries
China
Contacts
CONTACTSu-Wei Chen, Doctor
Outcome results
None listed