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

NCT07750548 | Not Yet Recruiting

• 1 other identifier: 202606087
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dissection, Aortic

Keywords

cardiopulmonary bypass; ischemic thrombosis lesions; ischemic thrombotic events; systemic inflammatroy response

Outcome Measures

Primary Outcomes (1)

• 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).

  within the prior 30 days after surgery

Secondary Outcomes (7)

• new ischemic/thrombosis events

  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

Study Arms (2)

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.

Behavioral: sirA-CPB strategy

the Control Group

ACTIVE COMPARATOR

the traditional CPB strtegy

Behavioral: the traditional CPB strategy

Interventions

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 sirA-CPB 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.

the Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Central Study Contacts

Lian Duan, MD

CONTACT

+8613549652849; duanlian_ida@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: August 6, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF