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This study is designed as a multicenter, randomized, assessor- blinded clinical trial.The primary aim of this trial is to assess whether retrograde inferior venal caval perfusion combined selective antegrade cerebral perfusion(ACP)under mild hypothermia, compared with moderate hypothermia combined with selective ACP alone, improves the outcome for the patients undergoing total aortic arch replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIVP group | Active Comparator | After total cardiopulmonary bypass was initiated, the patient is cooled slowly to induce moderate hypothermia(28-30℃). The combination of selective antegrade cerebral perfusion and retrograde inferior vena caval perfusion is performed. The antegrade perfusion flow rate was is maintained at 6-12 mL/min/kg.Pump pressure of retrograde perfusion was is maintained at 20-30 mmHg, and blood flow was is maintained at 8-12 mL/min/kg. |
|
| ACP group | Active Comparator | After total cardiopulmonary bypass was initiated, the patient is cooled slowly to induce moderate hypothermia(26-28℃). Only select antegrade cerebral perfusion is performed by maintaining the flow rate at 6-12 mL/min/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retrograde Inferior Vena Caval Perfusion | Procedure | Retrograde Inferior Vena Caval Perfusion is achieved by tethering the inferior vena cava with a band around the cannula and by clamping the distal end of the inferior vena cava drainage tube, which allowed a pump to drive oxygenated blood into the inferior vena cava. Pump pressure is maintained at 20-30 mmHg, and blood flow is maintained at 8-12 mL/min/kg. The aim of RIVP is to maintain the lower body perfusion during circulation arrest, and reduce the ischemia-associated vital organ injury. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite major complications | Newly Postoperative Renal Failure;Surgical Re-exploration；Operative Mortality;Deep Sternal Wound Infection;Stroke/Cerebrovascular Accident;Paraplegia | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Failure | up to 30 days | |
| Transient Neurological Deficit | The occurrence of postoperative agitation, confusion, delirium, obtundation or a transient focal neurologic deficit (resolution within 72 hours) without any evidence of new structural abnormality on computed tomography or magnetic resonance imaging. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of volume of blood products transfusion | The number of units of packed red blood cells , fresh-frozen plasma, pooled platelets and cryoprecipitate administered was collected from blood bank records | up to 30 days |
| Length of ICU stay |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Du, M.D | Contact | +8602818980601926 | dulei@scu.edu.cn | |
| Jing Lin, M.D | Contact | +8602818980605853 | 350576038@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Du, M.D | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33879045 | Derived | Lin J, Qin Z, Liu X, Xiong J, Wu Z, Guo Y, Kang D, Du L. Retrograde inferior vena caval perfusion for total aortic arch replacement surgery: a randomized pilot study. BMC Cardiovasc Disord. 2021 Apr 20;21(1):193. doi: 10.1186/s12872-021-02002-9. | |
| 31014386 | Derived | Lin J, Tan Z, Yao H, Hu X, Zhang D, Zhao Y, Xiong J, Dou B, Zhu X, Wu Z, Guo Y, Kang D, Du L. Retrograde Inferior Vena caval Perfusion for Total Aortic arch Replacement Surgery (RIVP-TARS): study protocol for a multicenter, randomized controlled trial. Trials. 2019 Apr 24;20(1):232. doi: 10.1186/s13063-019-3319-2. |
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| Select antegrade cerebral perfusion | Procedure | Antegrade cerebral perfusion is achieved using a 12 F cannula inserted into the brachiocephalic artery or right axillary artery. The antegrade perfusion flow rate is maintained at 6-12 mL/min/kg |
|
| up to 30 days |
| Acute Kidney Injury not requiring Dialysis | Kidney Disease Improving Global Outcomes (KDIGO) guidelines17 | up to 30 days |
| Myocardial Infarction | up to 30 days |
| Postoperative Prolonged Intubation | patients aged 18 years and older who require intubation for more than 24 hours patients aged 18 years and older undergoing isolated CABG who require intubation for more than 24 hours patients aged 18 years and older undergoing isolated CABG who require intubation for more than 24 hours patients aged 18 years and older undergoing isolated CABG who require intubation for more than 24 hours Patients who require intubation for more than 24 hours | up to 30 days |
| Paraparesis | Motor weakness in any lower extremity muscle group or unilateral paraplegia (Tarlov score 1-4 or, if present, a score of zero in a single lower extremity) | up to 30 days |
The duration of staying ICU postoperatively, time between administrated in ICU after the procedure to discharge from the ICU
| up to 30 days |
| Length of postoperative stay | the number of days between procedure and discharge, including any time patients spent at hospitals or long-term acute care facilities after transfer from our institution | up to 30 days |
| Gastrointestinal bleed | Gastrointestinal bleed is defined as unambiguous clinical or endoscopic evidence of blood in the gastrointestinal tract. Upper gastrointestinal bleeding (or haemorrhage) is that originating proximal to the ligament of Treitz, in practice from the oesophagus, stomach and duodenum. Lower gastrointestinal bleeding is that originating from the small bowel or colon. | up to 30 days |
| Postoperative ascites | Accumulation or retention of free fluid in the abdominal peritoneal cavity between the tissues lining the abdomen and abdominal organs. The fluid may be serous, hemorrhagic, or the result of inflammation or tumor metastasis to the peritoneum. | up to 30 days |
| Death | since incident surgery | 12 months |
| New onset dialysis (since incident surgery) status | Renal failure requiring dialysis | 12 months |
| Stroke | Any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain | 12 months |
| Myocardial infarction | Increase in serum cardiac biomarker values (preferably cardiac troponin) with at least one value above the 99th percentile upper reference limit and at least one of the following criteria: symptoms of ischaemia; new or presumed new significant ST segment or T wave ECG changes or new left bundle branch block; development of pathological Q waves on ECG; radiological or echocardiographic evidence of new loss of viable myocardium or new regional wall motion abnormality; identification of an intracoronary thrombus at angiography or autopsy（since incident surgery） | 12 months |
| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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