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Prophylactic IABP in High-risk Patients Undergoing CABG

NCT ID: NCT01950130

Last Updated: 2021-11-22

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-02-28

Brief Summary

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Due to advances and increased practice of interventional therapy for coronary artery disease, the rate of high-risk patients with severe coronary disease and reduced left ventricular function among patients undergoing coronary artery bypass grafting surgery (CABG) is increasing. The perioperative mortality in these patients is ≥ 5%. The perioperative and operative management for these patients has to be optimized in order to reduce their perioperative morbidity and mortality. One of the central aspects is perioperative maintenance of hemodynamic stability. The use of prophylactic IABP is a partly established, but not sufficiently evidence-based measure to reduce ventricular afterload and improve coronary perfusion pre-, intra- and postoperatively. Yet, it is an invasive procedure with potential complications. The planned trial should give an explicit answer, whether preoperative prophylactic IABP decreases 30-day all-cause mortality (primary endpoint) and long-term mortality (3, 6, 12 months; secondary endpoints) compared to preoperative conservative treatment in high-risk patients undergoing CABG.

Detailed Description

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Conditions

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Myocardial Infarction Coronary Artery Disease

Keywords

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IABP IABC coronary artery disease prophylactic cardiac assist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IABP group

Preoperative IABP insertion

Group Type EXPERIMENTAL

Preoperative IABC

Intervention Type PROCEDURE

IABP-Insertion upon inclusion into the trial and admission to the ICU

Control group

Preoperative conservative treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preoperative IABC

IABP-Insertion upon inclusion into the trial and admission to the ICU

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Hemodynamically stable high-risk patients before CABG, defined by the following criteria:

* Age \>18 years
* Isolated CABG planned
* Informed consent in trial participation given
* Any left ventricular functional impairment (regional wall motion abnormality or global LVEF\<55%) assessed via ventriculography or transthoracic or transeophageal echocardiography
* Elevated cardiac biomarkers (CK-MB \> 6% of total-CK, Troponin I \> 3-fold of specific test reference) or myocardial infarction (NSTEMI or STEMI) within the last 4 days.

Exclusion Criteria

* Contraindications for IABP
* Cardiogenic shock
* Shock of any other cause
* Critical preoperative state according to EuroSCORE II-criteria
* Cardiac surgical procedure other than CABG planned
* Severe comorbidity with life expectancy \< 6 months
* Incapability of giving informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Dr. Philippe Grieshaber

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philippe Grieshaber, MD

Role: STUDY_DIRECTOR

Giessen University

Locations

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Department of Adult and Pediatric Cardiovascular Surgery

Giessen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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A-1124

Identifier Type: -

Identifier Source: org_study_id