Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HP+CPB/DHCA group | Experimental | 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. |
|
| CPB/DHCA group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemoperfusion | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The need of vasoactive drugs | noradrenaline, epinephrine, dopamine and dobutamine | up to 30 days |
| The volume of blood transfusion in ICU | up to 30 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Yang, M.D | Contact | +8602518351979226 | 18351979226@163.com | |
| Hao Yao, M.D | Contact | +8602515895852288 | yaohao@njmu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33228727 | Derived | Yang J, Ji D, Zhu YQ, Ren Y, Zhang X, Dai HY, Sun X, Zhou Y, Chen ZY, Li QG, Yao H. Hemoperfusion with HA380 in acute type A aortic dissection patients undergoing aortic arch operation (HPAO): a randomized, controlled, double-blind clinical trial. Trials. 2020 Nov 23;21(1):954. doi: 10.1186/s13063-020-04858-2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| Length of ICU stay | up to 30 days |
| Length of postoperative stay | up to 30 days |
| Prolonged Postoperative Intubation | > 48h | up to 30 days |
| Total hospital expenses | up to 6 months |
| ID | Term |
|---|---|
| D006464 | Hemoperfusion |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided