ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery

This study has been terminated.
(Only 1 patient recruited and deemed ineligible.)
Sponsor:
Information provided by (Responsible Party):
Datascope Corp.
ClinicalTrials.gov Identifier:
NCT01253356
First received: December 2, 2010
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery
Device: IABP
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Datascope Corp.:

Primary Outcome Measures:
  • Safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Amputation, Clinically significant bleeding, Vascular complications


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    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



Enrollment: 1
Study Start Date: January 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Datascope Corp.
ClinicalTrials.gov Identifier: NCT01253356     History of Changes
Other Study ID Numbers: P-00002
Study First Received: December 2, 2010
Last Updated: January 5, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014