Hemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Aortic Arch Operation (HPAO)

Study Overview
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Brief Summary
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This study is a single-center, randomized, controlled, double-blind clinical trial. The main purpose of this study is to evaluate if hemoperfusion is sufficient to improve the prognosis of acute type A aortic dissection patients undergoing cardiopulmonary bypass and deep hypothermia circulatory arrest.

Official Title
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The Effects of Hemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Cardiopulmonary Bypass and Deep Hypothermic Circulatory Arrest: A Randomized, Controlled, Double-blinded Trial

Conditions
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Acute Type A Aortic Dissection With Arch Involvement, Cardiopulmonary Bypass, Deep Hypothermic Circulatory Arrest

Intervention / Treatment
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* Device: Hemoperfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 yr-75yr, regardless of gender Patients with Acute type A aortic dissection and arch involvement (onset time ≤ 7 days) Able to understand and sign the informed consent Exclusion Criteria: Unable to understand and sign the informed consent BMI ≥ 40 Pregnant Active hemorrhage or thrombocytopenic purpura Previous history of liver diseasess, renal insufficiency or cerebrovascular diseases Preoperative organ malperfusion Previous history of cardiac surgeries Oral anticoagulant or antiplatelet drugs within one week of disease onset Hereditary connective tissue diseases such as Marfan syndrome, Ehlers-Danlos and Loeys-Dietz syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HP+CPB/DHCA group<br>For patients randomized into the intervention group, a hemoperfusion device will be connected in series to the extracorporeal circulation machine in advance to ensure that every single patient will undergo continuous hemoperfusion from the beginning to the end of CPB. | Device: Hemoperfusion<br>* Hemoperfusion is achieved by blood filtration with a hemoperfusion device. Specifically, the hemoperfusion device composed of multiple parallel resin cartridges is connected in parallel to the oxygenator and blood reservoir and perfused at a rate of 200-250ml/min. The purpose of hemoperfusion is to decrease inflammatory mediators produced during cardiopulmonary bypass through resin cartridges adsorption, such as cytokines, free hemoglobin and other toxins. The ultimate goal of hemoperfusion is to decrease postoperative complications, improve postoperative recovery, and eventually shorten the length of hospital stay.<br>|
| No Intervention: CPB/DHCA group<br>For patients randomized into the CPB/DHCA group, no hemoperfusion device will be connect to the extracorporeal circulation machine. Patients will undergo CPB and DHCA without continuous hemoperfusion. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite major complications | Operative mortality, Secondary thoracotomy, New onset of postoperative renal failure requiring dialysis, Paraplegia, Stroke/cerebrovascular accidents, Low cardiac output syndrome, Reintubation, Severe liver dysfunction, ECMO support, Multiple organ dysfunction syndrome (MODS) | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the plasma levels of other inflammatory factors such as interleukin (IL)-6, IL-8, IL-10, IL-1β and TNF-α |  | up to 3 days | 
| Changes of plasma MIF levels during the perioperative period |  | up to 3 days | 
| Changes of plasma CRP levels during the perioperative period |  | up to 3 days | 
| Total drainage within the first 24 hours of surgery |  | 24 hours | 
| Incidence of postoperative acute kidney injury |  | up to 30 days | 
| Incidence of postoperative respiratory failure |  | up to 30 days | 
| Incidence of postoperative delirium |  | up to 30 days | 
| Incidence of postoperative liver injury |  | up to 30 days | 
| Incidence of postoperative myocardial infarction |  | up to 30 days | 
| Changes of the plasma II, VII, IX, X, XI and XII levels during the perioperative period |  | up to 2 days | 
| Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period |  | up to 3 days |