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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiopulmonary Bypass; Acute Type A Aortic Dissection With Arch Involvement; Deep Hypothermic Circulatory Arrest
• Intervention / Treatment: Device: Hemoperfusion

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • The Second Affiliated Hospital of Nanjing Medical University
      • Contact: Hao Yao, M.D; Phone Number: +8602515895852288; Email: yaohao@njmu.edu.cn
      • Principal Investigator: Hao Yao, M.D
      • Principal Investigator: Jing Yang, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	up to 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in the plasma levels of other inflammatory factors such as interleukin (IL)-6, IL-8, IL-10, IL-1β and TNF-α	up to 3 days
Changes of plasma MIF levels during the perioperative period	up to 3 days
Changes of plasma CRP levels during the perioperative period	up to 3 days
Total drainage within the first 24 hours of surgery	24 hours
Incidence of postoperative acute kidney injury	up to 30 days
Incidence of postoperative respiratory failure	up to 30 days
Incidence of postoperative delirium	up to 30 days
Incidence of postoperative liver injury	up to 30 days
Incidence of postoperative myocardial infarction	up to 30 days
Changes of the plasma II, VII, IX, X, XI and XII levels during the perioperative period	up to 2 days
Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period	up to 3 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The need of vasoactive drugs	noradrenaline, epinephrine, dopamine and dobutamine	up to 30 days
The volume of blood transfusion in ICU		up to 30 days
Length of ICU stay		up to 30 days
Length of postoperative stay		up to 30 days
Prolonged Postoperative Intubation	> 48h	up to 30 days
Total hospital expenses		up to 6 months

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 29, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Body Temperature Changes; Aneurysm; Aneurysm, Dissecting; Hypothermia
• Other Study ID Numbers: HP01PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No