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HELIox CardiOPlegia Trial During Cardiac surgERy — HELICOPTER-1  

C.Surgical Procedure; Cardiac Clinical Trial

Official title:
HELIox CardiOPlegia Trial During Cardiac surgERy

Clinical Trial Summary

The HELICOPTER-1 Trial is a single centre pilot study to determine the feasibility of administering Heliox in cardioplegia during cardiac surgery and whether it has the potential to reduce the incidence and severity of myocardial ischemia during and after cardiac surgery.

Clinical Trial Description

The HELICOPTER-1 Trial is a single centre, randomized trial evaluating the feasibility of administration of Heliox for prevention of myocardial ischemia in patients undergoing cardiac surgery. Half of the study population will be randomly assigned to the receive cardioplegia enriched with a 70:30 (Helium:Oxygen) Heliox mixture, while the other half will be randomized to receive the current clinical standard of care (nitrogen and oxygen in cardioplegia).

Subjects will be followed up daily during their post-operative course in hospital for clinical outcomes. A 30-day phone follow-up will be conducted for vital status and MI. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02745951
Study type Interventional
Source St. Michael's Hospital, Toronto
Contact David Mazer, MD
Phone 416-864-5825
Email mazerd@smh.ca
Status Recruiting
Phase N/A
Start date April 2016
Completion date June 2017
View Details
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