ACTRN12614000712606
Terminated
Phase 2
High risk patients undergoing prophylactic intraaortic balloon counterpulsation compared with standard care without intraaortic balloon pump: A feasibility study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cardiovascular disease
- Sponsor
- Royal Perth Hospital
- Enrollment
- 40
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.The patient is listed for cardiac surgery that includes CABG
- •2\.The treating surgical team considers prophylactic IABC may be of benefit
- •Severely impaired left ventricular function of any cause
- •Recent or ongoing myocardial ischaemia\+
- •Critical coronary artery stenosis
- •\+myocardial ischaemia defined by pain at rest, requirement for IV GTN or heparin, or elevated troponin.
Exclusion Criteria
- •1\.Patient age \<18 years
- •2\.Patient has an IABC, ventricular assist device or ECMO circuit in situ
- •3\.IABC placement is planned for an immediate therapeutic indication (e.g. cardiogenic shock, severe mitral regurgitation)
- •4\.Absolute contraindication to IABC
- •a.Severe bilateral lower limb peripheral vascular disease or bilateral femoral arterial grafting
- •b.Moderate or severe aortic regurgitation
- •c.Abdominal or thoracic aortic aneurysm, severe calcification or dissection
- •d.Infection overlying bilateral femoral arteries
- •5\.Treating clinician deems enrollment is not in the best interest of the patient
- •6\.Death is imminent and inevitable
Outcomes
Primary Outcomes
Not specified
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