Dissection, Aortic
Conditions
Keywords
cardiopulmonary bypass, ischemic thrombosis lesions, ischemic thrombotic events, systemic inflammatroy response
Brief 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. 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.
Interventions
BEHAVIORALsirA-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.
BEHAVIORALthe traditional CPB strategy
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.
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old and under 80 years old, both male and female are eligible; 2. Patients planning to undergo open TAAAD surgery; 3. The patient voluntarily participates in this trial and signs an informed consent form.
Exclusion criteria
1. History of tumors, mental illness, coagulation dysfunction, or hematological disorders; 2. Patients with preoperative thinking, language, or hearing communication disorders; 3. Severe preoperative liver and kidney dysfunction; 4. Critical preoperative states such as IABP, ECMO, and high-dose vasopressors; 5. Allergic to plastics, resins, or heparin; 6. Patients who refuse blood transfusions (Jehovah Witness); 7. Fever exceeding 38 ℃ or combined with systemic infection, sepsis; 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| new ischemic/thrombosis lesions | 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
| Measure | Time frame | Description |
|---|---|---|
| new ischemic/thrombosis events | 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. |
| the incidence of myocardial infarction (MI) | 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. |
| the incidence of ischemic stroke | 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. |
| the incidence of ischemic spinal cord injury | Within 3 years postoperatively | postoperative hemiplegia, paraplegia, or motor deficits with imaging evidence of spinal cord ischemia. |
| the incidence of deep vein thrombosis (DVT) | 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). |
| the incidence of pulmonary embolism (PE) | 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. |
| the incidence of local arterial embolism | Within 3 years postoperatively | The imaging examination shows poor or no arterial blood supply of limbs or organs. |
Contacts
CONTACTLian Duan, MD
Outcome results
None listed