Acute Type A Aortic Dissection With Arch Involvement, Cardiopulmonary Bypass, Deep Hypothermic Circulatory Arrest
Conditions
Brief summary
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.
Interventions
DEVICEHemoperfusion
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.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 yr-75yr, regardless of gender 2. Patients with Acute type A aortic dissection and arch involvement (onset time ≤ 7 days) 3. Able to understand and sign the informed consent
Exclusion criteria
1. Unable to understand and sign the informed consent 2. BMI ≥ 40 3. Pregnant 4. Active hemorrhage or thrombocytopenic purpura 5. Previous history of liver diseasess, renal insufficiency or cerebrovascular diseases 6. Preoperative organ malperfusion 7. Previous history of cardiac surgeries 8. Oral anticoagulant or antiplatelet drugs within one week of disease onset 9. Hereditary connective tissue diseases such as Marfan syndrome, Ehlers-Danlos and Loeys-Dietz syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite major complications | up to 30 days | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Total drainage within the first 24 hours of surgery | 24 hours |
| 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 |
| 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 |
| Incidence of postoperative acute kidney injury | up to 30 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU stay | up to 30 days | — |
| Length of postoperative stay | up to 30 days | — |
| Prolonged Postoperative Intubation | up to 30 days | \> 48h |
| Total hospital expenses | up to 6 months | — |
| The volume of blood transfusion in ICU | up to 30 days | — |
| The need of vasoactive drugs | up to 30 days | noradrenaline, epinephrine, dopamine and dobutamine |
Countries
China
Contacts
Primary ContactJing Yang, M.D
Backup ContactHao Yao, M.D
Outcome results
None listed