Glucocorticoid on the Prognosis of TEVAR

NCT ID: NCT02523300

Last Updated: 2015-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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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

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Aortic Dissection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TEVAR+GC

The patients underwent TEVAR. Then glucocorticoids will be intravenously given after TEVAR

Group Type EXPERIMENTAL

TEVAR

Intervention Type PROCEDURE

The patients will be undertaken TEVAR

Glucocorticoids

Intervention Type DRUG

About 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group

TEVAR+Vehicle

The patients underwent TEVAR. Then saline will be given after TEVAR

Group Type PLACEBO_COMPARATOR

TEVAR

Intervention Type PROCEDURE

The patients will be undertaken TEVAR

saline

Intervention Type DRUG

The other 120 patients will be given saline as control group

Interventions

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TEVAR

The patients will be undertaken TEVAR

Intervention Type PROCEDURE

Glucocorticoids

About 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group

Intervention Type DRUG

saline

The other 120 patients will be given saline as control group

Intervention Type DRUG

Other Intervention Names

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thoracic endovascular aortic repair methylprednisolone Vehicle

Eligibility Criteria

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Inclusion Criteria

1. age from 18 to 80, male or unpregnant female;
2. diagnosed as aortic dissection, excluding intramural hematoma and penetrating aortic ulcer;
3. complicated aortic dissection with definite indications of TEVAR;
4. voluntarily signed the informed consent form;
5. good compliance with the instructions and cooperate with follow-up.

Exclusion Criteria

1. no appropriate vessel approaches;
2. patients with connective tissue diseases (such as Marfan syndrome);
3. patients with endocrine disease,such as diabetes mellitus, or undergoing hormonotherapy;
4. bad compliance with the instructions and follow-up;
5. allergic to nitinol and contrast medium;
6. estimated life expectancy is less than 24 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zaiping JING

Director of Vascular Surgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zaiping Jing, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Vascular Surgery, Changhai Hospital

Central Contacts

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Jian Zhou, Doctor

Role: CONTACT

86-21-31161669

Lei Zhang, Doctor

Role: CONTACT

86-21-31161670

References

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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.

Reference Type DERIVED
PMID: 27013022 (View on PubMed)

Other Identifiers

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GC-AD-2015-07

Identifier Type: -

Identifier Source: org_study_id

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