Clinical trial NCT04007484: Hemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Aortic Arch Operation (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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Type A Aortic Dissection With Arch Involvement
Cardiopulmonary Bypass
Deep Hypothermic Circulatory Arrest
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Composite major complications
timeFrame: up to 30 days
Secondary outcomes:
measure: Changes in the plasma levels of other inflammatory factors such as interleukin (IL)-6, IL-8, IL-10, IL-1β and TNF-α
timeFrame: up to 3 days
measure: Changes of plasma MIF levels during the perioperative period
timeFrame: up to 3 days
measure: Changes of plasma CRP levels during the perioperative period
timeFrame: up to 3 days
measure: Total drainage within the first 24 hours of surgery
timeFrame: 24 hours
measure: Incidence of postoperative acute kidney injury
timeFrame: up to 30 days
measure: Incidence of postoperative respiratory failure
timeFrame: up to 30 days
measure: Incidence of postoperative delirium
timeFrame: up to 30 days
measure: Incidence of postoperative liver injury
timeFrame: up to 30 days
measure: Incidence of postoperative myocardial infarction
timeFrame: up to 30 days
measure: Changes of the plasma II, VII, IX, X, XI and XII levels during the perioperative period
timeFrame: up to 2 days
measure: Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period
timeFrame: up to 3 days
Other outcomes:
measure: The need of vasoactive drugs
timeFrame: up to 30 days
measure: The volume of blood transfusion in ICU
timeFrame: up to 30 days
measure: Length of ICU stay
timeFrame: up to 30 days
measure: Length of postoperative stay
timeFrame: up to 30 days
measure: Prolonged Postoperative Intubation
timeFrame: up to 30 days
measure: Total hospital expenses
timeFrame: up to 6 months
Locations:
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References:
citation: 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.