HELIox CardiOPlegia Trial During Cardiac surgERy

Study Overview
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Brief Summary
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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
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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.

Official Title
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HELIox CardiOPlegia Trial During Cardiac surgERy

Conditions
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C.Surgical Procedure; Cardiac

Intervention / Treatment
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* Other: Heliox
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Cardiac surgery with CPB where use of a coronary sinus catheter is indicated 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heliox<br>Cardioplegia enriched with a 70:30 (Helium:Oxygen) Heliox mixture while the patient is on cardiopulmonary bypass | Other: Heliox<br>* Half of the study population will be randomly assigned to receive cardioplegia enriched with a 70:30 (Helium:Oxygen) via a D100 pediatric oxygenator. The Heliox itself will need to be administered via an oxygen regulator using a low flowmeter.<br>|
| Active Comparator: Standard of care<br>Cardioplegia enriched with a Nitrogen and Oxygen mixture while the patient is on cardiopulmonary bypass | Other: Standard of care<br>* The other half will be randomized to Nitrogen:Oxygen mixture. This will be done through the standard of care cardioplegia apparatus. There will be no novel interventions administered in this group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of using Heliox to oxygenate the blood cardioplegia | 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. | 30 days from the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Myocardial Infarction | Myocardial infarction (MI) will be defined according to the Third Universal Definition of MI using the following two criteria: 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. 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 | 30 days from the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiopulmonary bypass, cardioplegia, cardioprotection, coronary artery bypass graft surgery, heliox