NCT02745951

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 3, 2016

Status Verified

April 1, 2016

Enrollment Period

8 months

First QC Date

April 18, 2016

Last Update Submit

May 2, 2016

Conditions

C.Surgical Procedure; Cardiac

Keywords

cardiopulmonary bypasscardioplegiacardioprotectioncoronary artery bypass graft surgeryheliox

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • New Myocardial Infarction

    30 days from the intervention

Study Arms (2)

Heliox

EXPERIMENTAL

Cardioplegia enriched with a 70:30 (Helium:Oxygen) Heliox mixture while the patient is on cardiopulmonary bypass

Other: Heliox

Standard of care

ACTIVE COMPARATOR

Cardioplegia enriched with a Nitrogen and Oxygen mixture while the patient is on cardiopulmonary bypass

Other: Standard of care

Interventions

HelioxOTHER

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.

Heliox
Standard of careOTHER

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.

Standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

RECRUITING

MeSH Terms

Interventions

helioxStandard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • David Mazer, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Mazer, MD

CONTACT

416-864-5825mazerd@smh.ca

Constantine Dalamagas, RRT, CPC

CONTACT

416-864-6060DalamagasC@smh.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 20, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

May 3, 2016

Record last verified: 2016-04

Locations

CA(1)