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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01253356
Other study ID # P-00002
Secondary ID
Status Terminated
Phase Phase 4
First received December 2, 2010
Last updated January 5, 2012
Start date January 2011
Est. completion date February 2012

Study information

Verified date January 2012
Source Datascope Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date February 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Genesis Medical Center Davenport Iowa

Sponsors (1)

Lead Sponsor Collaborator
Datascope Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Amputation, Clinically significant bleeding, Vascular complications 30 days Yes
Secondary 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
30 days No