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

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

Overview

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

• Behavioral sirA-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
• Behavioral the 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 perfu

Primary outcome measures

• new ischemic/thrombosis lesions [Time frame: within the prior 30 days after surgery]

Secondary outcome measures (7)

• 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]

Eligibility criteria

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07750548 · 202606087

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗