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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
88
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.
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGComposite 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)
Time frame: up to 30 days
Changes in the plasma levels of other inflammatory factors such as interleukin (IL)-6, IL-8, IL-10, IL-1β and TNF-α
Time frame: up to 3 days
Changes of plasma MIF levels during the perioperative period
Time frame: up to 3 days
Changes of plasma CRP levels during the perioperative period
Time frame: up to 3 days
Total drainage within the first 24 hours of surgery
Time frame: 24 hours
Incidence of postoperative acute kidney injury
Time frame: up to 30 days
Incidence of postoperative respiratory failure
Time frame: up to 30 days
Incidence of postoperative delirium
Time frame: up to 30 days
Incidence of postoperative liver injury
Time frame: up to 30 days
Incidence of postoperative myocardial infarction
Time frame: up to 30 days
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Changes of the plasma II, VII, IX, X, XI and XII levels during the perioperative period
Time frame: up to 2 days
Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period
Time frame: up to 3 days