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

Primary Purpose

Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

IABP

About this trial

This is an interventional prevention trial for Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Genesis Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

No IABP

Intra-Aortic Balloon Pump (IABP)

Arm Description

Standard of care and no IABP

Standard of care, IABP inserted < or = 3 hours before noncardiac surgery, maintained for > or = 12-24 hours after surgery

Outcomes

Primary Outcome Measures

Safety

Amputation, Clinically significant bleeding, Vascular complications

Secondary Outcome Measures

Efficacy

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

Full Information

NCT ID

NCT01253356

First Posted

December 2, 2010

Last Updated

January 5, 2012

Sponsor

Datascope Corp.

1. Study Identification

Unique Protocol Identification Number

NCT01253356

Brief Title

ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery

Acronym

ACTIONS

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 Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Terminated

Why Stopped

Only 1 patient recruited and deemed ineligible.

Study Start Date

January 2011 (undefined)

Primary Completion Date

January 2012 (Anticipated)

Study Completion Date

February 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Datascope Corp.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No IABP

Arm Type

No Intervention

Arm Description

Standard of care and no IABP

Arm Title

Intra-Aortic Balloon Pump (IABP)

Arm Type

Active Comparator

Arm Description

Standard of care, IABP inserted < or = 3 hours before noncardiac surgery, maintained for > or = 12-24 hours after surgery

Intervention Type

Device

Intervention Name(s)

IABP

Intervention Description

Insertion of intra-aortic balloon < or = 3 hours before noncardiac surgery and maintained > or = 12-24 hours after surgery

Primary Outcome Measure Information:

Title

Safety

Description

Amputation, Clinically significant bleeding, Vascular complications

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Efficacy

Description

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Don Poldermans, MD

Organizational Affiliation

Erasmus Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Genesis Medical Center

City

Davenport

State/Province

Iowa

ZIP/Postal Code

52803

Country

United States

12. IPD Sharing Statement

Learn more about this trial

ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery

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