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Prophylactic IABP in High-risk Patients Undergoing CABG

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01950130
Recruitment Status : Unknown
Verified February 2015 by Dr. Philippe Grieshaber, University of Giessen.
Recruitment status was:  Not yet recruiting
First Posted : September 25, 2013
Last Update Posted : February 18, 2015
Information provided by (Responsible Party):
Dr. Philippe Grieshaber, University of Giessen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Coronary Artery Disease Procedure: Preoperative IABC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prophylactic Preoperative Inatraaortic Balloon Pump (IABP) in High-risk Patients Undergoing Coronary Artery Bypass Surgery (CABG)
Study Start Date : June 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: IABP group
Preoperative IABP insertion
Procedure: Preoperative IABC
IABP-Insertion upon inclusion into the trial and admission to the ICU

No Intervention: Control group
Preoperative conservative treatment

Primary Outcome Measures :
  1. 30-day all-cause mortality post CABG [%] [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Survival at 3, 6, 12 months [%] [ Time Frame: 3, 6 and 12 months ]
  2. Duration of ICU stay [h] [ Time Frame: 48 hours (average) ]
  3. Dependence on medical inotropic support [ Time Frame: 48 hours (average) ]
  4. IABP-associated complications [ Time Frame: 8 days (average) ]
    IABP-associated complications occur most often during IABP-support. However, after weaning from IABP, patients can still have bleeding complications or thrombembolic complications. Therefore, IABP-associated complications are monitored during the whole hospital stay

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key 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.

Key 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01950130

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Contact: Philippe Grieshaber, MD +4964198556249

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Department of Adult and Pediatric Cardiovascular Surgery
Giessen, Germany, 35392
Principal Investigator: Philippe Grieshaber, MD         
Sponsors and Collaborators
University of Giessen
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Study Director: Philippe Grieshaber, MD Giessen University

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Responsible Party: Dr. Philippe Grieshaber, MD, University of Giessen Identifier: NCT01950130    
Other Study ID Numbers: A-1124
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015
Keywords provided by Dr. Philippe Grieshaber, University of Giessen:
coronary artery disease
cardiac assist
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases