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

• Sponsor: The Second Hospital of Nanjing Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04007484
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.9
• Patients Per Site Per Month: 3.7

Study Details

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Jan 2, 2019
• Anticipated Primary Completion Date: Oct 31, 2020
• Anticipated Study Completion Date: Dec 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 [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 [up to 3 days]

2. Changes of plasma MIF levels during the perioperative period [up to 3 days]

3. Changes of plasma CRP levels during the perioperative period [up to 3 days]

4. Total drainage within the first 24 hours of surgery [24 hours]

5. Incidence of postoperative acute kidney injury [up to 30 days]

6. Incidence of postoperative respiratory failure [up to 30 days]

7. Incidence of postoperative delirium [up to 30 days]

8. Incidence of postoperative liver injury [up to 30 days]

9. Incidence of postoperative myocardial infarction [up to 30 days]

10. Changes of the plasma II, VII, IX, X, XI and XII levels during the perioperative period [up to 2 days]

11. Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period [up to 3 days]

Other Outcome Measures

1. The need of vasoactive drugs [up to 30 days]

   noradrenaline, epinephrine, dopamine and dobutamine

2. The volume of blood transfusion in ICU [up to 30 days]

3. Length of ICU stay [up to 30 days]

4. Length of postoperative stay [up to 30 days]

5. Prolonged Postoperative Intubation [up to 30 days]

   > 48h

6. Total hospital expenses [up to 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210000

Sponsors and Collaborators

• The Second Hospital of Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Second Hospital of Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT04007484
• Other Study ID Numbers: HP01PI
• First Posted: Jul 5, 2019
• Last Update Posted: Mar 3, 2020
• Last Verified: May 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aneurysm, Dissecting; Hypothermia

Study Results

No Results Posted as of Mar 3, 2020