Dissection, AorticNCT07750548
sirA-CPB Strategy Reduces New Ischemic/Embolic Lesions After Acute Type A Aortic Dissection Surgery
A study testing sirA-CPB strategy and the traditional CPB strategy in people with Dissection, Aortic, run by Xiangya Hospital of Central South University.
Trial summary
Type A acute aortic dissection (TAAAD) is a life-threatening disease that typically requires emergency surgery to prevent rupture from causing major bleeding events, with insufficient attention paid to its thromboembolic events. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dissection, Aortic
- What is being tested?
- sirA-CPB strategy and the traditional CPB strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old and under 80 years old, both male and female are eligible;
- Patients planning to undergo open TAAAD surgery;
- The patient voluntarily participates in this trial and signs an informed consent form.
Who cannot join
- History of tumors, mental illness, coagulation dysfunction, or hematological disorders;
- Patients with preoperative thinking, language, or hearing communication disorders;
- Severe preoperative liver and kidney dysfunction;
- Critical preoperative states such as IABP, ECMO, and high-dose vasopressors;
- Allergic to plastics, resins, or heparin;
- Patients who refuse blood transfusions (Jehovah Witness);
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- Fever exceeding 38 ℃ or combined with systemic infection, sepsis;
- Has participated in other blood related clinical studies. Eliminating criteria
- 1) The patient requests revocation of informed consent and withdrawal from the study; 2) The included cases have had their surgeries cancelled due to various reasons, or the investigators believe that the intervention measures were not completed according to the plan; 3) The attending physician believes that continuing research is not beneficial for the patient.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Systemic Inflammatory Response Attenuating Cardiopulmonary Bypass Strategy Reduces New Ischemic/Embolic Lesions After Acute Type A Aortic Dissection Surgery: the sirA-CPB Randomized Clinical Trial
Type A acute aortic dissection (TAAAD) is a life-threatening disease that typically requires emergency surgery to prevent rupture from causing major bleeding events, with insufficient attention paid to its thromboembolic events. Although measures to avoid bleeding during the perioperative period and postoperative anticoagulation are routine in clinical practice, guidelines and consensus often emphasize monitoring the progression of connective tissue diseases, developing long-term healthy lifestyle habits after surgery, and specific anticoagulant therapy. It is difficult to find guidelines or consensus on maintaining overall balance of the coagulation system throughout the body during the perioperative period. Reasonable intervention during surgery may help improve prognosis. The new strategy of systemic inflammatory response attenuating cardiopulmonary bypass (sirA-CPB) in this study theoretically reduces the degree of systemic inflammatory response during surgery and reduces postoperative complications such as ischemic/thromboembolic events. This study does not increase participants' financial burden, only slightly modifying the original tubing and devices of CPB (cardiopulmonary bypass, also known as extracorporeal circulation) to reduce the gas-blood contacting foreign bodies area and time, maintain stable blood pressure, reduce intraoperative blood loss and inflammation after treatment, and lower fluid volume priming to achieve the goal of reducing the systemic inflammatory response during surgery. For safety reasons, a bypass has been set up and can be converted to traditional extracorporeal circulation in case of emergency during surgery. The inclusion criteria for this study are patients aged ≥ 18 years who are planning to undergo type A acute aortic dissection open surgery. If participants' age and intended surgery match, the investigators will arrange to introduce the participant to this study. But if patients have not signed the informed consent form; Currently participating in other clinical trials; Patients with communication impairments in thinking, language, or hearing; Preoperative history of coagulation dysfunction or hematological disorders; Severe liver and kidney dysfunction; History of mental illness; Patients who refuse blood transfusions (Jehovah Witness); Fever exceeding 38℃ or combined with systemic infection; The investigators will not include the patients in this study. The investigators need participants' cooperation to conduct telephone follow-up with participants at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months after discharge. Please reply to any questions related to treatment and rehabilitation, and agree to investigators inquiry of participants' follow-up information. Possible benefits will conclude reduce the incidence of systemic inflammation or infection after surgery, potentially reduce deep vein thrombosis, central nervous system dysfunction, cardiac, pulmonary, or renal complications, decrease blood transfusions during hospitalization, and reduce transfusion related costs. Meanwhile, the information obtained through participants will contribute to medical progress and benefit patients with similar conditions in the future. Of course, participants may also not benefit: this treatment may not reduce the patient's inflammatory response or blood transfusion during hospitalization, or postoperative complications related to the nervous system, heart, lungs, or kidneys.
- Conditions
- Dissection, Aortic
- Being tested
- sirA-CPB strategy, the traditional CPB strategy
- Keywords
- cardiopulmonary bypass, ischemic thrombosis lesions, ischemic thrombotic events, systemic inflammatroy response
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirA-CPB strategyBehavioural
The sirA-CPB strategy, with the same priming circuits and devices as the control group, but with a different connection method. During the bypass period, venous blood is drawn directly from the bypass to the centrifugal pump head, reducing the area and time of gas-blood foreign body contact between the blood and the blood reservoir. The residual blood after hemoadsorption treatment in the blood reservoir is intermittently replenished into the circulation, maintaining MAP65-100mmHg by increasing circulating blood volume, increasing centrifugal pump flow, or centrifugal pump pulsatile perfusion model. Ultrafiltration is not necessary. Closely cooperate with the surgical department to minimize the duration of circulatory arrest and CPB. Other measures such as organ protection, medication, and blood product transfusion are the same as those in the control group.
the traditional CPB strategyBehavioural
The control group using traditional cardiopulmonary bypass (CPB, extracorporeal circulation) strategy, including centrifugal pump head, membrane lung (with blood reservoir and oxygenator), ultrafiltration, hemoadsorption device, filter, and priming of circuits. During the bypass period, MAP was maintained at 50-80mmHg according to adult CPB guidelines, with a flow rate of 2.2-2.4L/min. Low temperature flow reduction or circulatory arrest was performed in conjunction with surgery. Selective perfusion of the brain or other important organs during circulatory arrest was performed, and myocardial protection measures such as cardiac arrest decompression were implemented. Uniform cooling and rewarming were performed, pH acid-base electrolyte balance was maintained, and hemodynamic stability was maintained intermittently with fluid replacement or inotropics. Ultrafiltration was used to concentrate circulating blood, and cell saver was used for intraoperative autologous blood.
| Study group | Role | What they receive |
|---|---|---|
| the sirA-CPB Group | Experimental | The intervention group adopted a new sirA-CPB strategy, with the same priming circuits and devices as the control group, but with a different connection method. Receives: Behavioral: sirA-CPB strategy |
| the Control Group | Active comparator | the traditional CPB strtegy Receives: Behavioral: the traditional CPB strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
new ischemic/thrombosis lesions
Imaging examination revealed new ischemic or embolic lesions in the non-surgical area, regardless of clinical symptoms. The non-surgical area includes one or more of the following six: brain, spinal cord, deep vein thrombosis, pulmonary embolism, heart, and peripheral arteries. Any positive findings, or more, are recorded as follows: 1. New findings: discovery time (day after surgery)+organ (heart, brain, spinal cord) name/vessel name (deep vein, pulmonary artery, peripheral artery)+range (length * width, or scattered distribution within a certain area)+symptoms (none/present)+signs (none/present).
Measured: within the prior 30 days after surgery
Secondary outcomes (7)
new ischemic/thrombosis events
the composite incidence of myocardial infarction (MI), ischemic stroke, ischemic spinal cord injury, deep vein thrombosis (DVT), pulmonary embolism (PE), and local arterial embolism.
Measured: Within 3 years postoperatively
the incidence of myocardial infarction (MI)
The diagnosis is made if cardiac troponin values is increased, when associated with the appearance of (i) new pathological Q waves or new left bundle branch block, or (ii) angiographically documented new graft or new native coronary artery occlusion, or (iii) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
Measured: Within 3 years postoperatively
the incidence of ischemic stroke
Ischemic stroke is defined as a new focal neurologic deficit lasting more than 24 hours confirmed by cerebral computed tomography and an attending neurologic consultant. The related clinical symptoms and signs include sudden unilateral hemiplegia, sudden syncope, sudden obnubilation, and sudden amaurosis. If a patient has any of these symptoms or signs, a highly specific examination (either cerebral computed tomography or magnetic resonance imaging) will be performed.
Measured: Within 3 years postoperatively
the incidence of ischemic spinal cord injury
postoperative hemiplegia, paraplegia, or motor deficits with imaging evidence of spinal cord ischemia.
Measured: Within 3 years postoperatively
the incidence of deep vein thrombosis (DVT)
DVT is defined as the thrombosis in the deep veins of upper and lower extremities, which is further confirmed by vascular image examination(ultrasound, CT or DSA).
Measured: Within 3 years postoperatively
the incidence of pulmonary embolism (PE)
PE is defined as thrombosis in the pulmonary vasculature indicated by pulmonary CTA. The related clinical symptoms and signs include chest tightness or pain, dyspnea, cyanosis, hemoptysis, and hacking cough. The subsequent specific examinations include pulmonary CTA, pulmonary angiography, or radionuclide imaging performed according to symptoms or signs.
Measured: Within 3 years postoperatively
the incidence of local arterial embolism
The imaging examination shows poor or no arterial blood supply of limbs or organs.
Measured: Within 3 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start20 Jul 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dissection, AorticStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DUAN LIAN, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750548
- Sponsor's protocol ID
- 202606087
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are not publicly available due to privacy reasons but are available from the corresponding author upon reasonable request. Further inquiries can be directed to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systemic Inflammatory Response Attenuating Cardiopulmonary Bypass Strategy Reduces New Ischemic/Embolic Lesions After Acute Type A Aortic Dissection Surgery: the sirA-CPB Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07750548
- Acronym / sponsor ID
- 202606087
- Conditions
- Dissection, Aortic
- Keywords
- cardiopulmonary bypass, ischemic thrombosis lesions, ischemic thrombotic events, systemic inflammatroy response
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 6 Aug 2026 (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.
Type A acute aortic dissection (TAAAD) is a life-threatening disease that typically requires emergency surgery to prevent rupture from causing major bleeding events, with insufficient attention paid to its thromboembolic events. Although measures to avoid bleeding during the perioperative period and postoperative anticoagulation are routine in clinical practice, guidelines and consensus often emphasize monitoring the progression of connective tissue diseases, developing long-term healthy lifestyle habits after surgery, and specific anticoagulant therapy. It is difficult to find guidelines or consensus on maintaining overall balance of the coagulation system throughout the body during the perioperative period. Reasonable intervention during surgery may help improve prognosis. The new strategy of systemic inflammatory response attenuating cardiopulmonary bypass (sirA-CPB) in this study theoretically reduces the degree of systemic inflammatory response during surgery and reduces postoperative complications such as ischemic/thromboembolic events. This study does not increase participants' financial burden, only slightly modifying the original tubing and devices of CPB (cardiopulmonary bypass, also known as extracorporeal circulation) to reduce the gas-blood contacting foreign bodies area and time, maintain stable blood pressure, reduce intraoperative blood loss and inflammation after treatment, and lower fluid volume priming to achieve the goal of reducing the systemic inflammatory response during surgery. For safety reasons, a bypass has been set up and can be converted to traditional extracorporeal circulation in case of emergency during surgery. The inclusion criteria for this study are patients aged ≥ 18 years who are planning to undergo type A acute aortic dissection open surgery. If participants' age and intended surgery match, the investigators will arrange to introduce the participant to this study. But if patients have not signed the informed consent form; Currently participating in other clinical trials; Patients with communication impairments in thinking, language, or hearing; Preoperative history of coagulation dysfunction or hematological disorders; Severe liver and kidney dysfunction; History of mental illness; Patients who refuse blood transfusions (Jehovah Witness); Fever exceeding 38℃ or combined with systemic infection; The investigators will not include the patients in this study. The investigators need participants' cooperation to conduct telephone follow-up with participants at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months after discharge. Please reply to any questions related to treatment and rehabilitation, and agree to investigators inquiry of participants' follow-up information. Possible benefits will conclude reduce the incidence of systemic inflammation or infection after surgery, potentially reduce deep vein thrombosis, central nervous system dysfunction, cardiac, pulmonary, or renal complications, decrease blood transfusions during hospitalization, and reduce transfusion related costs. Meanwhile, the information obtained through participants will contribute to medical progress and benefit patients with similar conditions in the future. Of course, participants may also not benefit: this treatment may not reduce the patient's inflammatory response or blood transfusion during hospitalization, or postoperative complications related to the nervous system, heart, lungs, or kidneys.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the sirA-CPB Group | Experimental | Behavioral: sirA-CPB strategyThe intervention group adopted a new sirA-CPB strategy, with the same priming circuits and devices as the control group, but with a different connection method. |
| the Control Group | Active comparator | Behavioral: the traditional CPB strategythe traditional CPB strtegy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old and under 80 years old, both male and female are eligible;
- Patients planning to undergo open TAAAD surgery;
- The patient voluntarily participates in this trial and signs an informed consent form.
Key exclusion criteria (9 listed)
- History of tumors, mental illness, coagulation dysfunction, or hematological disorders;
- Patients with preoperative thinking, language, or hearing communication disorders;
- Severe preoperative liver and kidney dysfunction;
- Critical preoperative states such as IABP, ECMO, and high-dose vasopressors;
- Allergic to plastics, resins, or heparin;
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 |
|---|---|---|
| sirA-CPB strategyThe sirA-CPB strategy, with the same priming circuits and devices as the control group, but with a different connection method. During the bypass period, venous blood is drawn directly from the bypass to the centrifugal pump head, reducing the area and time of gas-blood foreign body contact between the blood and the blood reservoir. The residual blood after hemoadsorption treatment in the blood reservoir is intermittently replenished into the circulation, maintaining MAP65-100mmHg by increasing circulating blood volume, increasing centrifugal pump flow, or centrifugal pump pulsatile perfusion model. Ultrafiltration is not necessary. Closely cooperate with the surgical department to minimize the duration of circulatory arrest and CPB. Other measures such as organ protection, medication, and blood product transfusion are the same as those in the control group. | Behavioural | the sirA-CPB Group |
| the traditional CPB strategyThe control group using traditional cardiopulmonary bypass (CPB, extracorporeal circulation) strategy, including centrifugal pump head, membrane lung (with blood reservoir and oxygenator), ultrafiltration, hemoadsorption device, filter, and priming of circuits. During the bypass period, MAP was maintained at 50-80mmHg according to adult CPB guidelines, with a flow rate of 2.2-2.4L/min. Low temperature flow reduction or circulatory arrest was performed in conjunction with surgery. Selective perfusion of the brain or other important organs during circulatory arrest was performed, and myocardial protection measures such as cardiac arrest decompression were implemented. Uniform cooling and rewarming were performed, pH acid-base electrolyte balance was maintained, and hemodynamic stability was maintained intermittently with fluid replacement or inotropics. Ultrafiltration was used to concentrate circulating blood, and cell saver was used for intraoperative autologous blood. | Behavioural | the Control Group |
Primary outcome
new ischemic/thrombosis lesions
Time frame: within the prior 30 days after surgery
Imaging examination revealed new ischemic or embolic lesions in the non-surgical area, regardless of clinical symptoms. The non-surgical area includes one or more of the following six: brain, spinal cord, deep vein thrombosis, pulmonary embolism, heart, and peripheral arteries. Any positive findings, or more, are recorded as follows: 1. New findings: discovery time (day after surgery)+organ (heart, brain, spinal cord) name/vessel name (deep vein, pulmonary artery, peripheral artery)+range (length * width, or scattered distribution within a certain area)+symptoms (none/present)+signs (none/present).
7 secondary outcomes
new ischemic/thrombosis events
Time frame: Within 3 years postoperatively
the incidence of myocardial infarction (MI)
Time frame: Within 3 years postoperatively
the incidence of ischemic stroke
Time frame: Within 3 years postoperatively
the incidence of ischemic spinal cord injury
Time frame: Within 3 years postoperatively
the incidence of deep vein thrombosis (DVT)
Time frame: Within 3 years postoperatively
the incidence of pulmonary embolism (PE)
Time frame: Within 3 years postoperatively
the incidence of local arterial embolism
Time frame: Within 3 years postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are not publicly available due to privacy reasons but are available from the corresponding author upon reasonable request. Further inquiries can be directed to the corresponding author.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing sirA-CPB strategy and the traditional CPB strategy in people with Dissection, Aortic, run by Xiangya Hospital of Central South University.
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: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lian Duan, MD (+8613549652849, duanlian_ida@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
new ischemic/thrombosis lesions (time frame: within the prior 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.