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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEVAR+GC | Experimental | The patients underwent TEVAR. Then glucocorticoids will be intravenously given after TEVAR |
|
| TEVAR+Vehicle | Placebo Comparator | The patients underwent TEVAR. Then saline will be given after TEVAR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEVAR | Procedure | The patients will be undertaken TEVAR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aorta-related adverse events | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality after TEVAR | 30 days | |
| Success rate of endovascular repair | 24 months | |
| Drug-related adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhou, Doctor | Contact | 86-21-31161669 | zhoujian1-2@163.com | |
| Lei Zhang, Doctor | Contact | 86-21-31161670 | heatstones@yeah.net |
| Name | Affiliation | Role |
|---|---|---|
| Zaiping Jing, Doctor | Department of Vascular Surgery, Changhai Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27013022 | Derived | 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. |
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| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| D005938 | Glucocorticoids |
| D008775 | Methylprednisolone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Glucocorticoids | Drug | About 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group |
|
|
| saline | Drug | The other 120 patients will be given saline as control group |
|
|
| 24 months |
| D000094683 |
| Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |