HELIox CardiOPlegia Trial During Cardiac surgERy

Not Applicable

• Conditions: C.Surgical Procedure; Cardiac
• Interventions: Other: Standard of care; Other: Heliox

• Registration Number: NCT02745951
• Lead Sponsor: Unity Health Toronto

Brief 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.

Detailed 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 Timeline

• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-20
• Last Update Submitted: 2016-05-02
• Last Update Posted: 2016-05-03
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Age 18 or older
• Cardiac surgery with CPB where use of a coronary sinus catheter is indicated

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Exclusion Criteria

• Patient refusal
• Recent myocardial infarction (less than 7 days old)
• Left ventricular ejection fraction less than 30%
• Known pregnancy on date of surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care	Cardioplegia enriched with a Nitrogen and Oxygen mixture while the patient is on cardiopulmonary bypass
Heliox	Heliox	Cardioplegia enriched with a 70:30 (Helium:Oxygen) Heliox mixture while the patient is on cardiopulmonary bypass

Primary Outcome Measures

Name	Time	Method
Feasibility of using Heliox to oxygenate the blood cardioplegia	30 days from the intervention	To determine the feasibility of using Heliox to oxygenate the blood cardioplegia. Feasibility will be measured according to subject enrollment rates and to measurement of the blood gas content of the cardioplegia solutions.

Secondary Outcome Measures

Name	Time	Method
New Myocardial Infarction	30 days from the intervention	Myocardial infarction (MI) will be defined according to the Third Universal Definition of MI using the following two criteria: 1. Serum levels of Troponin I: Values more than 10 times the 99th percentile of the upper limit from a normal baseline. If preoperative enzyme levels are abnormal, the post-operative enzymes must be greater than the baseline plus 10 times the upper limit from a normal baseline.; 2. ECG: At least one of the following i) New left bundle branch block ii) Development of new pathological Q waves iii) Imaging evidence of new loss of viable myocardium or new regional wall abnormality

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada