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The ABC Trial Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery? A Single Centre Pilot Study (ABC)

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ClinicalTrials.gov Identifier: NCT01623193
Recruitment Status : Unknown
Verified May 2014 by Stacy OBlenes, Capital District Health Authority, Canada.
Recruitment status was:  Recruiting
First Posted : June 19, 2012
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is a single centre pilot for a randomized trial comparing all-blood cardioplegia to more dilute 4:1 blood cardioplegia during cardiac surgery. The hypothesis is that all-blood cardioplegia will be associated with less blood transfusion and better cardiac function.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Valvular Heart Disease Other: All-blood cardioplegia Procedure: Standard cardioplegia Phase 4

Detailed Description:

This is a single centre randomized, double blind, 2 arm, parallel group pilot study comparing all-blood cardioplegia to 4:1 blood cardioplegia in patients undergoing cardiac surgery. This pilot study will support the design of a larger multicentre trial.

Subjects undergoing cardiac surgery will be randomized to receive either standard of care (4:1) or all-blood cardioplegia for myocardial protection. Neither of these cardioplegia approaches would be considered investigational. Each is in use at numerous cardiac surgical centres around the world. The cardioplegia will be delivered using the Quest medical MPS system which is a Health Canada Approved device.

Clinical endpoints will be evalauted (rate of blood transtransfusion, ICU stay, etc…). In a subset of subjects who meet specific criteria, ventricular function will be evaluated in the operating room using the CD Leycom INCA conductance catheter system.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The ABC Trial - Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery
Study Start Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Control
Patients receive standard 4:1 cardioplegia for myocardial protection during cardiac surgery
Procedure: Standard cardioplegia
This arm will receive standard 4:1 cardioplegia for myocardial protection during surgery
Experimental: Treatment
Patients receive all-blood cardiolpegia for myocardial protection during surgery
Other: All-blood cardioplegia
The treatment group will receive all-blood cardioplegia for myocardial protection during surgery


Outcome Measures

Primary Outcome Measures :
  1. Blood transfusion [ Time Frame: 30 days ]
    Number of units of packed red blood cells transfused

  2. Intra-op diastolic function [ Time Frame: day 1 ]
    Left ventricular chamber stiffness constant measured by conductance catheter in the operating room


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 day ]
    Mortality

  2. Duration of Ventilation [ Time Frame: 30 day ]
  3. Lentgh of stay ICU [ Time Frame: 30 days ]
  4. Length of stay - hospital [ Time Frame: 30 day ]
  5. Other blood product administration [ Time Frame: 30 day ]
  6. Hgb - arrival ICU [ Time Frame: day 1 ]
  7. Hgb - prior to Discharge [ Time Frame: 30 days ]
  8. Lowest post op Hgb [ Time Frame: 30 days ]
  9. Volume of crystalloid delivered in cardioplegia [ Time Frame: day 1 ]
  10. Fluid balance [ Time Frame: 30 d ]
  11. Reoperation rate for bleeding [ Time Frame: 30 days ]
  12. Inotrope score [ Time Frame: 30 day ]
    Score incorporating amount and number of inotropes administered

  13. Low output syndrome [ Time Frame: 30 days ]
  14. Troponin [ Time Frame: 24 hours post op ]
  15. Infection [ Time Frame: 30 days ]
    Composite according to standardized definitions

  16. intra-op Ventricular function [ Time Frame: day 1 ]
    as determined by conductance catheter


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients (male and female) undergoing isolated coronary artery bypass grafting,
  • isolated aortic or mitral repair or replacement, and
  • combined aortic or mitral valve repair or replacement and
  • coronary bypass grafting

Exclusion Criteria:

  • reoperation,
  • endocarditis,
  • dialysis dependant renal failure,
  • pre-operative ECMO or LVAD support,
  • contraindication to blood transfusion (ie. Jehovah's Witness), and
  • use of irreversible anti-platelet (other than ASA) and anticoagulant agents within 48h (ie. plavix, dabigitran, GpIIb/IIIa inhibitors, argatroban).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623193


Contacts
Contact: Stacy O'Blenes, MD 902 473-7890 stacy.oblenes@iwk.nshealth.ca
Contact: Greg Hirsch, MD 902 473-7890 Greg.Hirsch@dal.ca

Locations
Canada, Nova Scotia
Capital Health Recruiting
Halifax, Nova Scotia, Canada
Contact: Stacy O'Blenes, MD    902 473-7890    stacy.oblenes@iwk.nshealth.ca   
Contact: Greg Hirsch, MD    902 473-7890    greg.hirsch@dal.ca   
Principal Investigator: Stacy O'Blenes, MD         
Sub-Investigator: Greg Hirsch, MD         
Sponsors and Collaborators
Stacy OBlenes
Investigators
Principal Investigator: Stacy O'Blenes, MD Dalhousie University
More Information

Responsible Party: Stacy OBlenes, Principal Investigator, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01623193     History of Changes
Other Study ID Numbers: ABC Trial
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: May 15, 2014
Last Verified: May 2014

Keywords provided by Stacy OBlenes, Capital District Health Authority, Canada:
Cardioplegia
Blood transfusion
Cardiac function
Myocardial edema
Coronary artery disease
Valve disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases