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NCT Number: NCT07750548

sirA-CPB Strategy Reduces New Ischemic/Embolic Lesions After Acute Type A Aortic Dissection Surgery

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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);
  • Fever exceeding 38 ℃ or combined with systemic infection, sepsis;
  • Has participated in other blood related clinical studies. Eliminating criteria
  • 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.

Treatment and study plan

sirA-CPB strategy

Behavioral

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 strategy

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. new ischemic/thrombosis events

    Time frame: Within 3 years postoperatively

    the composite incidence of myocardial infarction (MI), ischemic stroke, ischemic spinal cord injury, deep vein thrombosis (DVT), pulmonary embolism (PE), and local arterial embolism.

  2. the incidence of myocardial infarction (MI)

    Time frame: Within 3 years postoperatively

    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.

  3. the incidence of ischemic stroke

    Time frame: Within 3 years postoperatively

    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.

  4. the incidence of ischemic spinal cord injury

    Time frame: Within 3 years postoperatively

    postoperative hemiplegia, paraplegia, or motor deficits with imaging evidence of spinal cord ischemia.

  5. the incidence of deep vein thrombosis (DVT)

    Time frame: Within 3 years postoperatively

    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).

  6. the incidence of pulmonary embolism (PE)

    Time frame: Within 3 years postoperatively

    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.

  7. the incidence of local arterial embolism

    Time frame: Within 3 years postoperatively

    The imaging examination shows poor or no arterial blood supply of limbs or organs.

Study contacts

Contact information is provided by the study sponsor or research team.

Lian Duan, MD

CONTACT

[email protected]

+8613549652849

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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