Antegrade Cerebral Perfusion and Retrograde Inferior Vena Caval Perfusion for Total Aortic Arch Replacement

Hypothermia Clinical Trial

— CARTAR  

Official title:

The Effect of Combination of Selective Antegrade Cerebral Perfusion With Retrograde Inferior Vena Caval Perfusion on the Outcomes in Patients Underwent Total Aortic Arch Replacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03607786
• Other study ID #: WCH-2018-24
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: April 2019
• Source: West China Hospital
• Contact: Lei Du, M.D
• Phone: +8602818980601926
• Email: dulei[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patient aged 18 yr-65yr

2. Patient underwent total aortic arch replacement

Exclusion Criteria:

1. Inability to understand/give informed consent,

2. Participation in another clinical trial that interferes with the primary or secondary outcomes of this trial.

3. Inability to obtain superior and inferior vena caval cannulation due to pericardium adhesion

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Circulatory Arrest
• Hypothermia
• Type A Aortic Dissection

Intervention

Procedure:
• Retrograde Inferior Vena Caval Perfusion
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.
• Select antegrade cerebral perfusion
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

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Length of ICU stay	The duration of staying ICU postoperatively, time between administrated in ICU after the procedure to discharge from the ICU	up to 30 days
Other	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
Other	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
Other	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
Other	Death	since incident surgery	12 months
Other	New onset dialysis (since incident surgery) status	Renal failure requiring dialysis	12 months
Other	Stroke	Any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain	12 months
Other	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
Primary	Composite major complications	Newly Postoperative Renal Failure;Surgical Re-exploration;Operative Mortality;Deep Sternal Wound Infection;Stroke/Cerebrovascular Accident;Paraplegia	up to 12 months
Secondary	Respiratory Failure		up to 30 days
Secondary	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.	up to 30 days
Secondary	Acute Kidney Injury not requiring Dialysis	Kidney Disease Improving Global Outcomes (KDIGO) guidelines17	up to 30 days
Secondary	Myocardial Infarction		up to 30 days
Secondary	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
Secondary	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