ANZICS CTG Endorsed Study
Prophylactic intra-aortic balloon counterpulsation in high-risk cardiac surgery: A pilot randomised controlled trial
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:
Ed Litton (Chair), Frances Bass, Anthony Delaney, Graham Hillis, Nicole Marrow (Project Manager), David McGiffin, Shay McGuinness, Chris Reid, Julian Smith, and Liz Yarad.
Australian and New Zealand Society of Cardiac and Thoracic Surgeons Database Program; MAQUET; Teleflex.
Heart Foundation $72,000
Intensive Care Foundation $34,000
Project Status as of June 2019
The PINBALL results manuscript was published in Heart Lung Circ. 2019 May 3.
Litton E, Bass F, Dickson C, Hillis G, Inskip D, Jacques T, McGiffin D, McGuiness S, Miller J, Parke R, Playford H, Reid C, Smith J, Solman N, Tran L, Yarad E, Delaney A; ANZICS Clinical Trials Group. Prophylactic Intra-Aortic Balloon Counterpulsation in High Risk Cardiac Surgery: The PINBALL Pilot Multicentre, Registry-Linked, Randomised, Controlled Feasibility Trial. Heart Lung Circ. 2019 May 3. pii: S1443-9506(19)30345-2. doi: 10.1016/j.hlc.2019.04.006. [Epub ahead of print] PubMed PMID: 31178278.
Ed Litton (email)