NCT01253356

ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery

A Multicenter, Randomized, Controlled Pilot Study of Intra-Aortic Balloon Counterpulsation to Prevent Perioperative Cardiac Events in High-Risk Cardiac Patients Undergoing Noncardiac Surgery

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Datascope Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	IABP	Insertion of intra-aortic balloon \< or = 3 hours before noncardiac surgery and maintained \> or = 12-24 hours after surgery

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-01-01
• Completion: 2012-02-01
• First posted: 2010-12-03
• Last updated: 2012-01-06

Locations

1 site across 1 country: United States