Antibiotic Prophylaxis for TEVAR

Antibiotic Prophylaxis for Thoracic EndoVascular Aortic Repair

The infection rate of thoracic endovascular aortic repair (TEVAR) is unknown due to a lack of epidemiological data. The rate currently available comes from researches conducted decades ago, when open surgery was the standard of care. Because of the potentially fatal consequences of a stent graft infection in the thoracic aorta, the investigators tend to prescribe antibiotic prophylaxis for at least three days. In this study, the investigators are going to collect data on patients receiving TEVAR in the past five years and provide the following information: a. the infection rate (MAGIC classification), b. the rate of fever, c. the results of the lab tests, such as the WBC count and C-reaction protein. d. risk factors associated with infection and fever.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Diseases; Aortic Dissection; Aortic Aneurysm, Thoracic; Coarctation of Aorta; Hematoma; Aorta
• Intervention / Treatment: Procedure: thoracic endovascular aortic repair

• Study Type: Observational
• Enrollment (Actual): 457

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hanzhou, Zhejiang, China
      • The First Affiliated Hospital, College of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who were diagnosed with thoracic aortic dissection, thoracic aortic aneurysm, thoracic aortic intramural hematoma, or other thoracic aortic diseases and underwent TEVAR during hospitalization

Description

Inclusion Criteria:

1. Diagnosed with thoracic aortic diseases
2. Received TEVAR

Exclusion Criteria:

1. Suspected infectious aortic disease, such as a mycotic aneurysm.
2. TEVAR combined with open surgery
3. Antibiotics have been used more than 24 hours before the operation
4. Combined with immune deficiency disease or using hormone or immunosuppressant；
5. The treatment is for the complications of TEVAR, such as endoleak
6. Endovascular aortic repair for abdominal aortic disease
7. History of open aortic surgery or heart surgery.
8. Revascularization of visceral arteries during the TEVAR

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving TEVAR	Procedure: thoracic endovascular aortic repair; In The TEVAR procedure, we implant a stent graft into the diseased area of the thoracic artery, providing a route for the blood to flow within the stent graft and excluding the diseased aorta.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection rate after TEVAR	Infection rate via MAGIC classification	during hospitalization (up to post-operation day 14)
Infection rate at one month after TEVAR	Infection rate via MAGIC classification	One month after TEVAR
Infection rate at six months after TEVAR	Infection rate via MAGIC classification	Six months after TEVAR
Infection rate at one year after TEVAR	Infection rate via MAGIC classification	One year after TEVAR

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fever	Defined as temperature ≥38.5℃	one day, two days, three days, one month, six months, one year after TEVAR
WBC count		one day, two days, three days after TEVAR
C-reaction protein		one day after TEVAR

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Fever; TEVAR; Antibiotic prophylaxis; MAGIC classification
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Hemorrhage; Heart Defects, Congenital; Cardiovascular Abnormalities; Aneurysm; Aneurysm, Dissecting; Aortic Coarctation; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Hematoma; Aortic Diseases
• Other Study ID Numbers: IIT20220172A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No