ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery

Phase 4

Terminated

• Conditions: Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery
• Interventions: Device: IABP

• Registration Number: NCT01253356
• Lead Sponsor: Datascope Corp.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Study Start: 2011-01
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Last Update Submitted: 2012-01-05
• Last Update Posted: 2012-01-06
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-Aortic Balloon Pump (IABP)	IABP	Standard of care, IABP inserted \< or = 3 hours before noncardiac surgery, maintained for \> or = 12-24 hours after surgery

Primary Outcome Measures

Name	Time	Method
Safety	30 days	Amputation, Clinically significant bleeding, Vascular complications

Secondary Outcome Measures

Name	Time	Method
Efficacy	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

Trial Locations

Locations (1)

Genesis Medical Center; 🇺🇸 Davenport, Iowa, United States