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

Cardiopulmonary Bypass Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04007484
• Other study ID #: HP01PI
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2019
• Source: The Second Hospital of Nanjing Medical University
• Contact: Jing Yang, M.D
• Phone: +8602518351979226
• Email: 18351979226[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 30, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Type A Aortic Dissection With Arch Involvement
• Aneurysm, Dissecting
• Cardiopulmonary Bypass
• Deep Hypothermic Circulatory Arrest
• Hypothermia

Intervention

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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The need of vasoactive drugs	noradrenaline, epinephrine, dopamine and dobutamine	up to 30 days
Other	The volume of blood transfusion in ICU		up to 30 days
Other	Length of ICU stay		up to 30 days
Other	Length of postoperative stay		up to 30 days
Other	Prolonged Postoperative Intubation	> 48h	up to 30 days
Other	Total hospital expenses		up to 6 months
Primary	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	Changes in the plasma levels of other inflammatory factors such as interleukin (IL)-6, IL-8, IL-10, IL-1ß and TNF-a		up to 3 days
Secondary	Changes of plasma MIF levels during the perioperative period		up to 3 days
Secondary	Changes of plasma CRP levels during the perioperative period		up to 3 days
Secondary	Total drainage within the first 24 hours of surgery		24 hours
Secondary	Incidence of postoperative acute kidney injury		up to 30 days
Secondary	Incidence of postoperative respiratory failure		up to 30 days
Secondary	Incidence of postoperative delirium		up to 30 days
Secondary	Incidence of postoperative liver injury		up to 30 days
Secondary	Incidence of postoperative myocardial infarction		up to 30 days
Secondary	Changes of the plasma II, VII, IX, X, XI and XII levels during the perioperative period		up to 2 days
Secondary	Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period		up to 3 days