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ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery (ACTIONS)

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ClinicalTrials.gov Identifier: NCT01253356
Recruitment Status : Terminated (Only 1 patient recruited and deemed ineligible.)
First Posted : December 3, 2010
Last Update Posted : January 6, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30 days compared with standard care alone, while maintaining acceptable safety with respect to vascular accesss-related complications.

Condition or disease Intervention/treatment Phase
Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery Device: IABP Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multicenter, Randomized, Controlled Pilot Study of Intra-Aortic Balloon Counterpulsation to Prevent Perioperative Cardiac Events in High-Risk Cardiac Patients Undergoing Noncardiac Surgery
Study Start Date : January 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : February 2012
Arms and Interventions

Arm Intervention/treatment
No Intervention: No IABP
Standard of care and no IABP
Active Comparator: Intra-Aortic Balloon Pump (IABP)
Standard of care, IABP inserted < or = 3 hours before noncardiac surgery, maintained for > or = 12-24 hours after surgery
Device: IABP
Insertion of intra-aortic balloon < or = 3 hours before noncardiac surgery and maintained > or = 12-24 hours after surgery


Outcome Measures

Primary Outcome Measures :
  1. Safety [ Time Frame: 30 days ]
    Amputation, Clinically significant bleeding, Vascular complications


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 30 days ]

    A composite of the following:

    All-cause mortality, Cardiovascular mortality, Hemorrhagic or ischemic stroke, New nonfatal myocardial infarction, New or worsening congestive heart failure, Hemodynamically significant arrhythmia requiring intervention



Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients > 18 years with planned elective major abdominal, noncardiac thoracic, head and neck, vascular, or orthopedic surgery and guideline-treated iscehmic heart disease with left ventricular dysfunction (systolic ejection fraction < or = 30%)

Exclusion Criteria:

  • Unstable coronary syndromes Decompensated or NYHA Class IV heart failure Hemodynamic instability Cardiac biomarker instability Need for surgical procedure interfering with placement of IABP Cardiogenic shock Septic shock Contraindication to IABP use Clinical need for IABP ASA score > or = 5 Pregnancy Inability to provide informed consent
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01253356


Locations
United States, Iowa
Genesis Medical Center
Davenport, Iowa, United States, 52803
Sponsors and Collaborators
Datascope Corp.
Investigators
Principal Investigator: Don Poldermans, MD Erasmus Medical Center
More Information

Responsible Party: Datascope Corp.
ClinicalTrials.gov Identifier: NCT01253356     History of Changes
Other Study ID Numbers: P-00002
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases