Prophylactic INtra-aortic BALLoon Counterpulsation in High-Risk Cardiac Surgery: A Pilot Randomised Controlled Trial

Phase 2

• Conditions: Surgery - Surgical techniques; Cardiovascular disease; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12614000712606
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

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

3.Either:
Severely impaired left ventricular function of any cause
Or:
Recent or ongoing myocardial ischaemia+
Or:
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

7.Weight <40kg

8.Patient is highly unlikely to be contactable at 6 months for follow up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2 or more participants recruited per site per month[6 month follow up from date of index cardiac surgery];Greater than or equal to 90% of participants receiving the assigned intervention preoperatively [6 month follow up from date of index cardiac surgery];Greater than or equal to 90% of participants with complete follow up i.e. survival status is known at six months post index cardiac surgery. [6 month follow up from date of index cardiac surgery]

Secondary Outcome Measures

Name	Time	Method
Quality of life using EQ-5D[3 months and 6 months];Balloon pump safety (limb ischaemia, local infection, device failure, bleeding).[In-hospital];Mortality[In-hospital, 30-days, 3 months, 6 months];Morbidity (postoperative acute kidney injury, peak post operative troponin, postoperative cerebrovascular accident)[In-hospital];Composite safety and efficacy outcome (balloon pump-associated limb ischaemia or bleeding, mortality, acute kidney injury, acute myocardial infarction, cerebrovascular accident, quality of life). Quality of life assessed using E!-5D[In hospital, 3-months, 6-months];IABP timing[Duration from insertion to removal];Length of ICU stay[ICU discharge];Length of Stay Hospital[Hospital discharge following index admission. ]