Antibiotic Prophylaxis for TEVAR

Aortic Dissection Clinical Trial

Official title:

Antibiotic Prophylaxis for Thoracic EndoVascular Aortic Repair

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05405790
• Other study ID #: IIT20220172A
• Status: Active, not recruiting
• Start date: January 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 457
• Est. completion date: December 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Dissecting
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Coarctation
• Aortic Diseases
• Aortic Dissection
• Coarctation of Aorta
• Hematoma

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, College of Medicine, Zhejiang University	Hanzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection rate after TEVAR	Infection rate via MAGIC classification	during hospitalization (up to post-operation day 14)
Primary	Infection rate at one month after TEVAR	Infection rate via MAGIC classification	One month after TEVAR
Primary	Infection rate at six months after TEVAR	Infection rate via MAGIC classification	Six months after TEVAR
Primary	Infection rate at one year after TEVAR	Infection rate via MAGIC classification	One year after TEVAR
Secondary	Fever	Defined as temperature =38.5?	one day, two days, three days, one month, six months, one year after TEVAR
Secondary	WBC count		one day, two days, three days after TEVAR
Secondary	C-reaction protein		one day after TEVAR