Antibiotic Prophylaxis for TEVAR

Active, not recruiting

• Conditions: Aortic Dissection; Coarctation of Aorta; Aortic Diseases; Aortic Aneurysm, Thoracic; Hematoma; Aorta
• Interventions: Procedure: thoracic endovascular aortic repair

• Registration Number: NCT05405790
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-05-30
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Primary Completion: 2023-01-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-21
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 457

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving TEVAR	thoracic endovascular aortic repair	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University; 🇨🇳 Hanzhou, Zhejiang, China