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出境医 / 临床实验 / Hemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Aortic Arch Operation (HPAO) (HPAO)

Hemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Aortic Arch Operation (HPAO) (HPAO)

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.

Condition or disease Intervention/treatment Phase
Acute Type A Aortic Dissection With Arch Involvement Cardiopulmonary Bypass Deep Hypothermic Circulatory Arrest Device: Hemoperfusion Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: HP+CPB/DHCA group
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.
 Device: Hemoperfusion
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.
No Intervention: CPB/DHCA group
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.
Outcome Measures
Primary Outcome Measures :
  1. Composite major complications [ Time Frame: up to 30 days ]
    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 :
  1. 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 ]
  2. Changes of plasma MIF levels during the perioperative period [ Time Frame: up to 3 days ]
  3. Changes of plasma CRP levels during the perioperative period [ Time Frame: up to 3 days ]
  4. Total drainage within the first 24 hours of surgery [ Time Frame: 24 hours ]
  5. Incidence of postoperative acute kidney injury [ Time Frame: up to 30 days ]
  6. Incidence of postoperative respiratory failure [ Time Frame: up to 30 days ]
  7. Incidence of postoperative delirium [ Time Frame: up to 30 days ]
  8. Incidence of postoperative liver injury [ Time Frame: up to 30 days ]
  9. Incidence of postoperative myocardial infarction [ Time Frame: up to 30 days ]
  10. Changes of the plasma II, VII, IX, X, XI and XII levels during the perioperative period [ Time Frame: up to 2 days ]
  11. Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period [ Time Frame: up to 3 days ]

Other Outcome Measures:
  1. The need of vasoactive drugs [ Time Frame: up to 30 days ]
    noradrenaline, epinephrine, dopamine and dobutamine

  2. The volume of blood transfusion in ICU [ Time Frame: up to 30 days ]
  3. Length of ICU stay [ Time Frame: up to 30 days ]
  4. Length of postoperative stay [ Time Frame: up to 30 days ]
  5. Prolonged Postoperative Intubation [ Time Frame: up to 30 days ]
    > 48h

  6. Total hospital expenses [ Time Frame: up to 6 months ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 18 yr-75yr, regardless of gender
  2. Patients with Acute type A aortic dissection and arch involvement (onset time ≤ 7 days)
  3. Able to understand and sign the informed consent

Exclusion Criteria:

  1. Unable to understand and sign the informed consent
  2. BMI ≥ 40
  3. Pregnant
  4. Active hemorrhage or thrombocytopenic purpura
  5. Previous history of liver diseasess, renal insufficiency or cerebrovascular diseases
  6. Preoperative organ malperfusion
  7. Previous history of cardiac surgeries
  8. Oral anticoagulant or antiplatelet drugs within one week of disease onset
  9. Hereditary connective tissue diseases such as Marfan syndrome, Ehlers-Danlos and Loeys-Dietz syndrome
Contacts and Locations

Contacts
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Contact: Jing Yang, M.D +8602518351979226 18351979226@163.com
Contact: Hao Yao, M.D +8602515895852288 yaohao@njmu.edu.cn

Locations
Layout table for location information
China, Jiangsu
The Second Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Hao Yao, M.D    +8602515895852288    yaohao@njmu.edu.cn   
Principal Investigator: Hao Yao, M.D         
Principal Investigator: Jing Yang, M.D         
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date March 3, 2020
Actual Study Start Date  ICMJE January 2, 2019
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2020) 		Composite major complications [ Time Frame: up to 30 days ]
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)
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Changes in the plasma interleukin (IL)-6 levels during the perioperative period [ Time Frame: 3 days ]
  • Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period [ Time Frame: 3 days ]
  • Composite major complications [ Time Frame: up to 30 days ]
    New onset of postoperative renal failure requiring dialysis; Operative mortality; Secondary thoracotomy; Paraplegia; Stroke/cerebrovascular accidents
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2020)
  • 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 ]
  • Changes of plasma MIF levels during the perioperative period [ Time Frame: up to 3 days ]
  • Changes of plasma CRP levels during the perioperative period [ Time Frame: up to 3 days ]
  • Total drainage within the first 24 hours of surgery [ Time Frame: 24 hours ]
  • Incidence of postoperative acute kidney injury [ Time Frame: up to 30 days ]
  • Incidence of postoperative respiratory failure [ Time Frame: up to 30 days ]
  • Incidence of postoperative delirium [ Time Frame: up to 30 days ]
  • Incidence of postoperative liver injury [ Time Frame: up to 30 days ]
  • Incidence of postoperative myocardial infarction [ Time Frame: up to 30 days ]
  • Changes of the plasma II, VII, IX, X, XI and XII levels during the perioperative period [ Time Frame: up to 2 days ]
  • Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period [ Time Frame: up to 3 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Changes in the plasma levels of other inflammatory factors such as interleukin (IL)-8, IL-10 and TNF-α [ Time Frame: up to 3 days ]
  • Changes of plasma MIF levels during the perioperative period [ Time Frame: up to 3 days ]
  • Changes of plasma CRP levels during the perioperative period [ Time Frame: up to 3 days ]
  • Total drainage within the first 24 hours of surgery [ Time Frame: 24 hours ]
  • Postoperative acute kidney injury [ Time Frame: up to 30 days ]
  • Postoperative respiratory failure [ Time Frame: up to 30 days ]
  • Postoperative delirium [ Time Frame: up to 30 days ]
  • Postoperative liver injury [ Time Frame: up to 30 days ]
  • Postoperative myocardial infarction [ Time Frame: up to 30 days ]
Current Other Pre-specified Outcome Measures
 (submitted: February 29, 2020)
  • The need of vasoactive drugs [ Time Frame: up to 30 days ]
    noradrenaline, epinephrine, dopamine and dobutamine
  • The volume of blood transfusion in ICU [ Time Frame: up to 30 days ]
  • Length of ICU stay [ Time Frame: up to 30 days ]
  • Length of postoperative stay [ Time Frame: up to 30 days ]
  • Prolonged Postoperative Intubation [ Time Frame: up to 30 days ]
    > 48h
  • Total hospital expenses [ Time Frame: up to 6 months ]
Original Other Pre-specified Outcome Measures
 (submitted: July 1, 2019)
  • All-cause mortality [ Time Frame: up to 30 days ]
  • The incidence of Multiple organ dysfunction syndrome (MODS) [ Time Frame: up to 30 days ]
  • The volume of blood transfusion in ICU [ Time Frame: up to 30 days ]
  • Length of ICU stay [ Time Frame: up to 30 days ]
  • Length of postoperative stay [ Time Frame: up to 30 days ]
  • Prolonged Postoperative Intubation [ Time Frame: up to 30 days ]
  • Total hospital expenses [ Time Frame: up to 6 months ]
 
Descriptive Information
Brief Title  ICMJE Hemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Aortic Arch Operation (HPAO)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Type A Aortic Dissection With Arch Involvement
  • Cardiopulmonary Bypass
  • Deep Hypothermic Circulatory Arrest
Intervention  ICMJE Device: Hemoperfusion
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.
Study Arms  ICMJE
  • Experimental: HP+CPB/DHCA group
    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.
    Intervention: Device: Hemoperfusion
  • No Intervention: CPB/DHCA group
    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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 29, 2020) 		88
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2019) 		60
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients aged 18 yr-75yr, regardless of gender
  2. Patients with Acute type A aortic dissection and arch involvement (onset time ≤ 7 days)
  3. Able to understand and sign the informed consent

Exclusion Criteria:

  1. Unable to understand and sign the informed consent
  2. BMI ≥ 40
  3. Pregnant
  4. Active hemorrhage or thrombocytopenic purpura
  5. Previous history of liver diseasess, renal insufficiency or cerebrovascular diseases
  6. Preoperative organ malperfusion
  7. Previous history of cardiac surgeries
  8. Oral anticoagulant or antiplatelet drugs within one week of disease onset
  9. Hereditary connective tissue diseases such as Marfan syndrome, Ehlers-Danlos and Loeys-Dietz syndrome
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04007484
Other Study ID Numbers  ICMJE HP01PI
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Second Hospital of Nanjing Medical University
Study Sponsor  ICMJE The Second Hospital of Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Second Hospital of Nanjing Medical University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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