NCT01253356

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

January 6, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

December 2, 2010

Last Update Submit

January 5, 2012

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Safety

    Amputation, Clinically significant bleeding, Vascular complications

    30 days

Secondary Outcomes (1)

  • Efficacy

    30 days

Study Arms (2)

No IABP

NO INTERVENTION

Standard of care and no IABP

Intra-Aortic Balloon Pump (IABP)

ACTIVE COMPARATOR

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

Device: IABP

Interventions

IABPDEVICE

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

Intra-Aortic Balloon Pump (IABP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Study Officials

  • Don Poldermans, MD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 3, 2010

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

January 6, 2012

Record last verified: 2012-01

Locations

US(1)