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PINBALL Pilot

ANZICS CTG Endorsed Study

PINBALL Pilot

Prophylactic intra-aortic balloon counterpulsation in high-risk cardiac surgery: A pilot randomised controlled trial

Study Description

The PINBALL Pilot RCT is a multicentre trial that will assess the feasibility of conducting a definitive phase III RCT of prophylactic IABC in addition to standard care, versus standard care without prophylactic IABC for high risk patients undergoing cardiac surgery. We propose to conduct a prospective multicentre pilot study of high-risk patients undergoing cardiac surgery in order to assess the feasibility of a phase III RCT. The primary hypothesis is that a phase III RCT of prophylactic IABC in high-risk patients undergoing cardiac surgery is feasible on the basis of achieving threshold criteria for recruitment rates, delivery of the assigned intervention and study follow up.

The primary outcome will be study feasibility. A phase III RCT of prophylactic IABC in high risk patients undergoing cardiac surgery will be deemed feasible if all three of the following criteria are met:

  • ≥ 2 participants recruited per site per month
  • ≥ 90% of participants receiving the assigned intervention preoperatively
  • ≥ 90% of participants with complete follow up

Management Committee

Ed Litton (Chair), Frances Bass, Anthony Delaney, Graham Hillis, Nicole Marrow (Project Manager), David McGiffin, Shay McGuinness, Chris Reid, Julian Smith, and Liz Yarad.

Collaborators

Australian and New Zealand Society of Cardiac and Thoracic Surgeons Database Program; MAQUET; Teleflex.

Sample Size

40 patients

Funding

Heart Foundation $72,000
Intensive Care Foundation $34,000

Project Status as of June 2018

Awaiting outcome of ANZICS CTG endorsement review of results manuscript.

Contact

Ed Litton (email)

Reference

CTG1415-05
ACTRN 12614000712606