HELICOPTER-1: HELIox CardiOPlegia Trial During Cardiac surgERy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Heliox Cardioplegia enriched with a 70:30 (Helium:Oxygen) Heliox mixture while the patient is on cardiopulmonary bypass |
Other: Heliox
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.
|
| Active Comparator: Standard of care Cardioplegia enriched with a Nitrogen and Oxygen mixture while the patient is on cardiopulmonary bypass |
Other: Standard of care
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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: 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 or older
-
Cardiac surgery with CPB where use of a coronary sinus catheter is indicated
Exclusion Criteria:
-
Patient refusal
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Recent myocardial infarction (less than 7 days old)
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Left ventricular ejection fraction less than 30%
-
Known pregnancy on date of surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B1W8 |
Sponsors and Collaborators
- Unity Health Toronto
Investigators
- Principal Investigator: David Mazer, MD, Unity Health Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15 - 311