NCT02523300

Glucocorticoid on the Prognosis of TEVAR

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Aortic Dissection

Interventions

Type	Name	Description
PROCEDURE	TEVAR	The patients will be undertaken TEVAR
DRUG	Glucocorticoids	About 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group
DRUG	saline	The other 120 patients will be given saline as control group

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-09-01
• Completion: 2019-09-01
• First posted: 2015-08-14
• Last updated: 2015-08-14