An interventional study of sirA-CPB strategy and the traditional CPB strategy in Dissection, Aortic, sponsored by Xiangya Hospital of Central South University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Xiangya Hospital of Central South University · Not applicable, Interventional, and Other
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.
205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.
This study's planned enrollment of 270 is above the median of 114 across 86 interventional studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →Xiangya Hospital of Central South University is the lead sponsor of 174 studies on the registry; 77 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1) The patient requests revocation of 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: sirA-CPB strategy
the traditional CPB strtegy
Behavioral: the traditional CPB strategy
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 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.
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).
Time frame: within the prior 30 days after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: Within 3 years postoperatively
the incidence of ischemic spinal cord injury
postoperative hemiplegia, paraplegia, or motor deficits with imaging evidence of spinal cord ischemia.
Time frame: 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).
Time frame: 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.
Time frame: Within 3 years postoperatively
the incidence of local arterial embolism
The imaging examination shows poor or no arterial blood supply of limbs or organs.
Time frame: Within 3 years postoperatively
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Start is estimated for Jul 2026; primary completion for Dec 2029, 41 months later.
Of 49 interventional studies with no phase under Aortic Dissection, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23. This study's planned 41 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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