Glucocorticoid on the Prognosis of TEVAR

August 13, 2015 updated by: Zaiping JING, Changhai Hospital

Prognostic Value of Single-dose Glucocorticoid After Endovascular Repair for Aortic Dissection

To explore the potential prognostic effect of glucocorticoid on the postoperative aorta-related adverse events after aortic dissections patients underwent thoracic endovascular aortic repair (TEVAR), glucocorticoid (30mg/kg) will be intravenously given within 2h after TEVAR.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, open, single-center, randomized controlled trial. Number of patients: 240 patients will be included and undertaken TEVAR.About 120 patients will be given glucocorticoid within 2h after TEVAR as experimental group, and the other 120 patients will be given saline as control group.

Follow-up: 1. aortic computed tomographic angiography (CTA) examination 6, 12 and 24 months after TEVAR; 2. telephone or clinical follow-up at 1, 2, 3, 6, 12 and 24 months.

Primary outcome measure: aorta-related adverse events. Second outcome measure: 30-day mortality after TEVAR, success rate of endovascular repair, drug-related adverse events.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age from 18 to 80, male or unpregnant female;
  2. diagnosed as aortic dissection, excluding intramural hematoma and penetrating aortic ulcer;
  3. complicated aortic dissection with definite indications of TEVAR;
  4. voluntarily signed the informed consent form;
  5. good compliance with the instructions and cooperate with follow-up.

Exclusion Criteria:

  1. no appropriate vessel approaches;
  2. patients with connective tissue diseases (such as Marfan syndrome);
  3. patients with endocrine disease,such as diabetes mellitus, or undergoing hormonotherapy;
  4. bad compliance with the instructions and follow-up;
  5. allergic to nitinol and contrast medium;
  6. estimated life expectancy is less than 24 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEVAR+GC
The patients underwent TEVAR. Then glucocorticoids will be intravenously given after TEVAR
Procedure: TEVAR
The patients will be undertaken TEVAR
Other Names:
  • thoracic endovascular aortic repair
Drug: Glucocorticoids
About 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group
Other Names:
  • methylprednisolone
Placebo Comparator: TEVAR+Vehicle
The patients underwent TEVAR. Then saline will be given after TEVAR
Procedure: TEVAR
The patients will be undertaken TEVAR
Other Names:
  • thoracic endovascular aortic repair
Drug: saline
The other 120 patients will be given saline as control group
Other Names:
  • Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aorta-related adverse events
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day mortality after TEVAR
Time Frame: 30 days
30 days
Success rate of endovascular repair
Time Frame: 24 months
24 months
Drug-related adverse events
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Zaiping Jing, Doctor, Department of Vascular Surgery, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC-AD-2015-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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