Glucocorticoid on the Prognosis of TEVAR
Prognostic Value of Single-dose Glucocorticoid After Endovascular Repair for Aortic Dissection
1 other identifier
interventional
240
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2015
CompletedFirst Posted
Study publicly available on registry
August 14, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedAugust 14, 2015
August 1, 2015
1.9 years
August 11, 2015
August 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Aorta-related adverse events
24 months
Secondary Outcomes (3)
30-day mortality after TEVAR
30 days
Success rate of endovascular repair
24 months
Drug-related adverse events
24 months
Study Arms (2)
TEVAR+GC
EXPERIMENTALThe patients underwent TEVAR. Then glucocorticoids will be intravenously given after TEVAR
TEVAR+Vehicle
PLACEBO COMPARATORThe patients underwent TEVAR. Then saline will be given after TEVAR
Interventions
The patients will be undertaken TEVAR
About 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group
The other 120 patients will be given saline as control group
Eligibility Criteria
You may qualify if:
- age from 18 to 80, male or unpregnant female;
- diagnosed as aortic dissection, excluding intramural hematoma and penetrating aortic ulcer;
- complicated aortic dissection with definite indications of TEVAR;
- voluntarily signed the informed consent form;
- good compliance with the instructions and cooperate with follow-up.
You may not qualify if:
- no appropriate vessel approaches;
- patients with connective tissue diseases (such as Marfan syndrome);
- patients with endocrine disease,such as diabetes mellitus, or undergoing hormonotherapy;
- bad compliance with the instructions and follow-up;
- allergic to nitinol and contrast medium;
- estimated life expectancy is less than 24 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Wu M, Zhang L, Bao J, Zhao Z, Lu Q, Feng R, Song C, Zhou J, Jing Z. Postoperative glucocorticoid enhances recovery after endovascular aortic repair for chronic type B aortic dissection: a single-center experience. BMC Cardiovasc Disord. 2016 Mar 25;16:59. doi: 10.1186/s12872-016-0234-2.
PMID: 27013022DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zaiping Jing, Doctor
Department of Vascular Surgery, Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Vascular Surgery Department
Study Record Dates
First Submitted
August 11, 2015
First Posted
August 14, 2015
Study Start
October 1, 2015
Primary Completion
September 1, 2017
Study Completion
September 1, 2019
Last Updated
August 14, 2015
Record last verified: 2015-08