HELIox CardiOPlegia Trial During Cardiac surgERy (HELICOPTER-1)

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.

Study Overview

• Status: Unknown
• Conditions: C.Surgical Procedure; Cardiac
• Intervention / Treatment: Other: Heliox; Other: Standard of care

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Mazer, MD; Phone Number: 416-864-5825; Email: mazerd@smh.ca
• Study Contact Backup: Name: Constantine Dalamagas, RRT, CPC; Phone Number: 5753 416-864-6060; Email: DalamagasC@smh.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B1W8
      • Recruiting
      • St. Michael's Hospital
      • Contact: Constantine Dalamagas, RRT, CPC; Phone Number: 5753 416-864-6060; Email: DalamagasC@smh.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: David Mazer, MD, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: April 18, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: May 2, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: cardiopulmonary bypass; cardioprotection; coronary artery bypass graft surgery; cardioplegia; heliox
• Other Study ID Numbers: 15 - 311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED