An interventional study of TEVAR and Glucocorticoids in Aortic Dissection, sponsored by Changhai Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-08-14.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Prevention
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.
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.
386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.
This study's planned enrollment of 240 is above the median of 84 across 198 interventional studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
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Exclusion Criteria:
The patients underwent TEVAR. Then glucocorticoids will be intravenously given after TEVAR
Procedure: TEVAR · Drug: Glucocorticoids
The patients underwent TEVAR. Then saline will be given after TEVAR
Procedure: TEVAR · Drug: saline
The patients will be undertaken TEVAR
Also known as: thoracic endovascular aortic repair
About 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group
Also known as: methylprednisolone
The other 120 patients will be given saline as control group
Also known as: Vehicle
Aorta-related adverse events
Time frame: 24 months
30-day mortality after TEVAR
Time frame: 30 days
Success rate of endovascular repair
Time frame: 24 months
Drug-related adverse events
Time frame: 24 months
No study locations are listed for this record.
This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Changhai Hospital