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
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2019
CompletedFirst Submitted
Initial submission to the registry
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedMarch 3, 2020
May 1, 2019
1.8 years
July 1, 2019
February 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
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
- +6 more secondary outcomes
Other Outcomes (6)
The need of vasoactive drugs
up to 30 days
The volume of blood transfusion in ICU
up to 30 days
Length of ICU stay
up to 30 days
- +3 more other outcomes
Study Arms (2)
HP+CPB/DHCA group
EXPERIMENTALFor 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.
CPB/DHCA group
NO INTERVENTIONFor 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients aged 18 yr-75yr, regardless of gender
- Patients with Acute type A aortic dissection and arch involvement (onset time ≤ 7 days)
- Able to understand and sign the informed consent
You may not qualify if:
- Unable to understand and sign the informed consent
- BMI ≥ 40
- Pregnant
- Active hemorrhage or thrombocytopenic purpura
- Previous history of liver diseasess, renal insufficiency or cerebrovascular diseases
- Preoperative organ malperfusion
- Previous history of cardiac surgeries
- Oral anticoagulant or antiplatelet drugs within one week of disease onset
- Hereditary connective tissue diseases such as Marfan syndrome, Ehlers-Danlos and Loeys-Dietz syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000, China
Related Publications (1)
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.
PMID: 33228727DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2019
First Posted
July 5, 2019
Study Start
January 2, 2019
Primary Completion
October 31, 2020
Study Completion
December 30, 2020
Last Updated
March 3, 2020
Record last verified: 2019-05