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โ† Trials
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CompaRison of FEmorofemoral Bypass and Left-Heart ByPass Techniques in Open Thoracoabdominal AortIc Aneurysm Repair

RecruitingNAAges 18 Years - anyAllBeijing Anzhen Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (โ‰ฅ18 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 Behรงet'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.
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What it tests

  • Thoracoabdominal aortic aneurysm repair under fCPB
  • Thoracoabdominal aortic aneurysm repair under LHB
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Where

1 site
Beijing Anzhen Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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