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临床试验/NCT07750548
NCT07750548尚未招募不适用

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

Xiangya Hospital of Central South University0 个研究点目标入组 270 人开始时间: 2026年7月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
270
主要终点
new ischemic/thrombosis lesions

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: sirA-CPB strategy (Behavioral)

the Control Group

Active Comparator

the traditional CPB strtegy

干预措施: the traditional CPB strategy (Behavioral)

结局指标

主要结局

new ischemic/thrombosis lesions

时间窗: 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).

次要结局

  • new ischemic/thrombosis events(Within 3 years postoperatively)
  • the incidence of local arterial embolism(Within 3 years postoperatively)
  • the incidence of myocardial infarction (MI)(Within 3 years postoperatively)
  • the incidence of ischemic stroke(Within 3 years postoperatively)
  • the incidence of ischemic spinal cord injury(Within 3 years postoperatively)
  • the incidence of deep vein thrombosis (DVT)(Within 3 years postoperatively)
  • the incidence of pulmonary embolism (PE)(Within 3 years postoperatively)

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Principal Investigator
主要研究者

DUAN LIAN

MD

Xiangya Hospital of Central South University

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