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ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery

NCT01253356 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2012-01-06

No results posted yet for this study

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

DEVICE

IABP

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

Sponsors & Collaborators

  • Datascope Corp.

    lead INDUSTRY

Principal Investigators

  • Don Poldermans, MD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-01-31
Completion
2012-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01253356 on ClinicalTrials.gov