Antibiotic Prophylaxis for TEVAR

• Sponsor: First Affiliated Hospital of Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05405790
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 41.7

Study Details

Study Description

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, we tend to prescribe antibiotic prophylaxis for at least three days. In this study, we 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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Dissection; Aortic Diseases; Aortic Aneurysm, Thoracic; Coarctation of Aorta; Hematoma; Aorta	Procedure: thoracic endovascular aortic repair

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Antibiotic Prophylaxis for Thoracic EndoVascular Aortic Repair
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Infection rate at one day after TEVAR [One day after TEVAR]

   Infection rate via MAGIC classification

2. Infection rate at two days after TEVAR [Two days after TEVAR]

   Infection rate via MAGIC classification

3. Infection rate at three days after TEVAR [Three days after TEVAR]

   Infection rate via MAGIC classification

4. Infection rate at one month after TEVAR [One month after TEVAR]

   Infection rate via MAGIC classification

5. Infection rate at six months after TEVAR [Six months after TEVAR]

   Infection rate via MAGIC classification

6. Infection rate at one year after TEVAR [One year after TEVAR]

   Infection rate via MAGIC classification

Secondary Outcome Measures

1. Fever [one day, two days, three days, one month, six months, one year after TEVAR]

   Defined as temperature >38.5℃

2. WBC count [one day, two days, three days after TEVAR]

3. C-reaction protein [one day, two days, three days after TEVAR]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital, College of Medicine, Zhejiang University	Hanzhou	Zhejiang	China

Sponsors and Collaborators

• First Affiliated Hospital of Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hongkun Zhang, MD, Chief physician, First Affiliated Hospital of Zhejiang University
• ClinicalTrials.gov Identifier: NCT05405790
• Other Study ID Numbers: IIT20220172A
• First Posted: Jun 6, 2022
• Last Update Posted: Jun 6, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hongkun Zhang, MD, Chief physician, First Affiliated Hospital of Zhejiang University: Antibiotic prophylaxis; TEVAR; Fever; MAGIC classification
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aneurysm, Dissecting; Aortic Diseases; Aortic Coarctation; Aortic Aneurysm, Thoracic; Hematoma

Study Results

No Results Posted as of Jun 6, 2022