Acute Type A Aortic Dissection With Arch InvolvementHPAONCT04007484
Hemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Aortic Arch Operation (HPAO)
A study testing Hemoperfusion in people with Acute Type A Aortic Dissection With Arch Involvement and Cardiopulmonary Bypass, run by The Second Hospital of Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Type A Aortic Dissection With Arch Involvement, Cardiopulmonary Bypass, Deep Hypothermic Circulatory Arrest
- What is being tested?
- Hemoperfusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Hao Yao, M.D, +8602515895852288, yaohao@njmu.edu.cn
Hao Yao, M.D
About this study
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
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.
- Conditions
- Acute Type A Aortic Dissection With Arch Involvement, Cardiopulmonary Bypass, Deep Hypothermic Circulatory Arrest
- Being tested
- Hemoperfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoperfusionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HP+CPB/DHCA group | Experimental | 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. Receives: Device: Hemoperfusion |
| CPB/DHCA group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: up to 3 days
Changes of plasma MIF levels during the perioperative period
Measured: up to 3 days
Changes of plasma CRP levels during the perioperative period
Measured: up to 3 days
Total drainage within the first 24 hours of surgery
Measured: 24 hours
Incidence of postoperative acute kidney injury
Measured: up to 30 days
Incidence of postoperative respiratory failure
Measured: up to 30 days
Incidence of postoperative delirium
Measured: up to 30 days
Incidence of postoperative liver injury
Measured: up to 30 days
Incidence of postoperative myocardial infarction
Measured: up to 30 days
Changes of the plasma II, VII, IX, X, XI and XII levels during the perioperative period
Measured: up to 2 days
Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start2 Jan 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Type A Aortic Dissection With Arch InvolvementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007484
- Sponsor's protocol ID
- HP01PI
- Acronym
- HPAO
- Status last verified
- May 2019
- First submitted
- 1 Jul 2019
- Last updated
- 3 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33228727
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04007484
- Acronym / sponsor ID
- HPAO / HP01PI
- Conditions
- Acute Type A Aortic Dissection With Arch Involvement, Cardiopulmonary Bypass, Deep Hypothermic Circulatory Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HP+CPB/DHCA group | Experimental | Device: HemoperfusionFor 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 intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemoperfusionHemoperfusion 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. | Device | HP+CPB/DHCA group |
Primary outcome
Composite major complications
Time frame: 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)
11 secondary outcomes
Changes in the plasma levels of other inflammatory factors such as interleukin (IL)-6, IL-8, IL-10, IL-1β and TNF-α
Time frame: up to 3 days
Changes of plasma MIF levels during the perioperative period
Time frame: up to 3 days
Changes of plasma CRP levels during the perioperative period
Time frame: up to 3 days
Total drainage within the first 24 hours of surgery
Time frame: 24 hours
Incidence of postoperative acute kidney injury
Time frame: up to 30 days
Incidence of postoperative respiratory failure
Time frame: up to 30 days
Incidence of postoperative delirium
Time frame: up to 30 days
Incidence of postoperative liver injury
Time frame: up to 30 days
Incidence of postoperative myocardial infarction
Time frame: up to 30 days
Changes of the plasma II, VII, IX, X, XI and XII levels during the perioperative period
Time frame: up to 2 days
Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period
Time frame: up to 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Derived from this study: PubMed 33228727Yang 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemoperfusion in people with Acute Type A Aortic Dissection With Arch Involvement and Cardiopulmonary Bypass, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Yang, M.D (+8602518351979226, 18351979226@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite major complications (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04007484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.