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

Primary Purpose

Type A Aortic Dissection, Circulatory Arrest, Hypothermia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Retrograde Inferior Vena Caval Perfusion
Select antegrade cerebral perfusion
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type A Aortic Dissection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West China Hospital of Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

RIVP group

ACP group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Composite major complications
Newly Postoperative Renal Failure;Surgical Re-exploration;Operative Mortality;Deep Sternal Wound Infection;Stroke/Cerebrovascular Accident;Paraplegia

Secondary Outcome Measures

Respiratory Failure
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.
Acute Kidney Injury not requiring Dialysis
Kidney Disease Improving Global Outcomes (KDIGO) guidelines17
Myocardial Infarction
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
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)

Full Information

First Posted
July 24, 2018
Last Updated
April 8, 2019
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03607786
Brief Title
Antegrade Cerebral Perfusion and Retrograde Inferior Vena Caval Perfusion for Total Aortic Arch Replacement
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type A Aortic Dissection, Circulatory Arrest, Hypothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIVP group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ACP group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Retrograde Inferior Vena Caval Perfusion
Other Intervention Name(s)
Select antegrade cerebral perfusion
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Select antegrade cerebral perfusion
Intervention Description
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
Primary Outcome Measure Information:
Title
Composite major complications
Description
Newly Postoperative Renal Failure;Surgical Re-exploration;Operative Mortality;Deep Sternal Wound Infection;Stroke/Cerebrovascular Accident;Paraplegia
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Respiratory Failure
Time Frame
up to 30 days
Title
Transient Neurological Deficit
Description
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.
Time Frame
up to 30 days
Title
Acute Kidney Injury not requiring Dialysis
Description
Kidney Disease Improving Global Outcomes (KDIGO) guidelines17
Time Frame
up to 30 days
Title
Myocardial Infarction
Time Frame
up to 30 days
Title
Postoperative Prolonged Intubation
Description
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
Time Frame
up to 30 days
Title
Paraparesis
Description
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)
Time Frame
up to 30 days
Other Pre-specified Outcome Measures:
Title
The number of volume of blood products transfusion
Description
The number of units of packed red blood cells , fresh-frozen plasma, pooled platelets and cryoprecipitate administered was collected from blood bank records
Time Frame
up to 30 days
Title
Length of ICU stay
Description
The duration of staying ICU postoperatively, time between administrated in ICU after the procedure to discharge from the ICU
Time Frame
up to 30 days
Title
Length of postoperative stay
Description
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
Time Frame
up to 30 days
Title
Gastrointestinal bleed
Description
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.
Time Frame
up to 30 days
Title
Postoperative ascites
Description
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.
Time Frame
up to 30 days
Title
Death
Description
since incident surgery
Time Frame
12 months
Title
New onset dialysis (since incident surgery) status
Description
Renal failure requiring dialysis
Time Frame
12 months
Title
Stroke
Description
Any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain
Time Frame
12 months
Title
Myocardial infarction
Description
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)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient aged 18 yr-65yr Patient underwent total aortic arch replacement Exclusion Criteria: Inability to understand/give informed consent, Participation in another clinical trial that interferes with the primary or secondary outcomes of this trial. Inability to obtain superior and inferior vena caval cannulation due to pericardium adhesion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Du, M.D
Phone
+8602818980601926
Email
dulei@scu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Lin, M.D
Phone
+8602818980605853
Email
350576038@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Du, M.D
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimin Li, M.D

12. IPD Sharing Statement

Citations:
PubMed Identifier
33879045
Citation
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.
Results Reference
derived
PubMed Identifier
31014386
Citation
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.
Results Reference
derived

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

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