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

Not Applicable

• Conditions: Deep Hypothermic Circulatory Arrest; Acute Type A Aortic Dissection With Arch Involvement; Cardiopulmonary Bypass
• Interventions: Device: Hemoperfusion

• Registration Number: NCT04007484
• Lead Sponsor: The Second Hospital of Nanjing Medical University

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 available

Study Timeline

• Study Start: 2019-01-02
• Status Verified: 2019-05
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-05
• Last Update Submitted: 2020-02-29
• Last Update Posted: 2020-03-03
• Primary Completion: 2020-10-31
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HP+CPB/DHCA group	Hemoperfusion	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period	up to 3 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
Incidence of postoperative respiratory failure	up to 30 days

Trial Locations

Locations (1)

The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China