Back to resultsHemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Aortic Arch Operation (HPAO) (HPAO)
Primary Purpose
Acute Type A Aortic Dissection With Arch Involvement, Cardiopulmonary Bypass, Deep Hypothermic Circulatory Arrest
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hemoperfusion
Sponsored by
About this trial
This is an interventional treatment trial for Acute Type A Aortic Dissection With Arch Involvement
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 yr-75yr, regardless of gender
- Patients with Acute type A aortic dissection and arch involvement (onset time ≤ 7 days)
- Able to understand and sign the informed consent
Exclusion Criteria:
- Unable to understand and sign the informed consent
- BMI ≥ 40
- Pregnant
- Active hemorrhage or thrombocytopenic purpura
- Previous history of liver diseasess, renal insufficiency or cerebrovascular diseases
- Preoperative organ malperfusion
- Previous history of cardiac surgeries
- Oral anticoagulant or antiplatelet drugs within one week of disease onset
- Hereditary connective tissue diseases such as Marfan syndrome, Ehlers-Danlos and Loeys-Dietz syndrome
Sites / Locations
- The Second Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HP+CPB/DHCA group
CPB/DHCA group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Changes in the plasma levels of other inflammatory factors such as interleukin (IL)-6, IL-8, IL-10, IL-1β and TNF-α
Changes of plasma MIF levels during the perioperative period
Changes of plasma CRP levels during the perioperative period
Total drainage within the first 24 hours of surgery
Incidence of postoperative acute kidney injury
Incidence of postoperative respiratory failure
Incidence of postoperative delirium
Incidence of postoperative liver injury
Incidence of postoperative myocardial infarction
Changes of the plasma II, VII, IX, X, XI and XII levels during the perioperative period
Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period
Full Information
NCT ID
NCT04007484
First Posted
July 1, 2019
Last Updated
February 29, 2020
Sponsor
The Second Hospital of Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04007484
Brief Title
Hemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Aortic Arch Operation (HPAO)
Acronym
HPAO
Official Title
The Effects of Hemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Cardiopulmonary Bypass and Deep Hypothermic Circulatory Arrest: A Randomized, Controlled, Double-blinded Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Nanjing Medical University
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Type A Aortic Dissection With Arch Involvement, Cardiopulmonary Bypass, Deep Hypothermic Circulatory Arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HP+CPB/DHCA group
Arm Type
Experimental
Arm Description
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.
Arm Title
CPB/DHCA group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hemoperfusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite major complications
Description
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
Secondary Outcome Measure Information:
Title
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
Title
Changes of plasma MIF levels during the perioperative period
Time Frame
up to 3 days
Title
Changes of plasma CRP levels during the perioperative period
Time Frame
up to 3 days
Title
Total drainage within the first 24 hours of surgery
Time Frame
24 hours
Title
Incidence of postoperative acute kidney injury
Time Frame
up to 30 days
Title
Incidence of postoperative respiratory failure
Time Frame
up to 30 days
Title
Incidence of postoperative delirium
Time Frame
up to 30 days
Title
Incidence of postoperative liver injury
Time Frame
up to 30 days
Title
Incidence of postoperative myocardial infarction
Time Frame
up to 30 days
Title
Changes of the plasma II, VII, IX, X, XI and XII levels during the perioperative period
Time Frame
up to 2 days
Title
Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period
Time Frame
up to 3 days
Other Pre-specified Outcome Measures:
Title
The need of vasoactive drugs
Description
noradrenaline, epinephrine, dopamine and dobutamine
Time Frame
up to 30 days
Title
The volume of blood transfusion in ICU
Time Frame
up to 30 days
Title
Length of ICU stay
Time Frame
up to 30 days
Title
Length of postoperative stay
Time Frame
up to 30 days
Title
Prolonged Postoperative Intubation
Description
> 48h
Time Frame
up to 30 days
Title
Total hospital expenses
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 yr-75yr, regardless of gender
Patients with Acute type A aortic dissection and arch involvement (onset time ≤ 7 days)
Able to understand and sign the informed consent
Exclusion Criteria:
Unable to understand and sign the informed consent
BMI ≥ 40
Pregnant
Active hemorrhage or thrombocytopenic purpura
Previous history of liver diseasess, renal insufficiency or cerebrovascular diseases
Preoperative organ malperfusion
Previous history of cardiac surgeries
Oral anticoagulant or antiplatelet drugs within one week of disease onset
Hereditary connective tissue diseases such as Marfan syndrome, Ehlers-Danlos and Loeys-Dietz syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Yang, M.D
Phone
+8602518351979226
Email
18351979226@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Yao, M.D
Phone
+8602515895852288
Email
yaohao@njmu.edu.cn
Facility Information:
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Yao, M.D
Phone
+8602515895852288
Email
yaohao@njmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Hao Yao, M.D
First Name & Middle Initial & Last Name & Degree
Jing Yang, M.D
12. IPD Sharing Statement
Citations:
PubMed Identifier
33228727
Citation
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.
Results Reference
derived
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Hemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Aortic Arch Operation (HPAO)
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