Ignite Creation Date:
2024-05-06 @ 7:25 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02523300
Status:
UNKNOWN
Last Update Posted:
2015-08-14
First Post:
2015-08-11
Brief Title:
Glucocorticoid on the Prognosis of TEVAR
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
Prognostic Value of Single-dose Glucocorticoid After Endovascular Repair for Aortic Dissection
Status:
UNKNOWN
Status Verified Date:
2015-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 30mgkg 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 TEVARAbout 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None