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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Stacy OBlenes, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01623193
First received: June 13, 2012
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Coronary Artery Disease
Valvular Heart Disease
Other: All-blood cardioplegia
Procedure: Standard cardioplegia
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The ABC Trial - Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Blood transfusion [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Number of units of packed red blood cells transfused

  • Intra-op diastolic function [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Left ventricular chamber stiffness constant measured by conductance catheter in the operating room


Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
    Mortality

  • Duration of Ventilation [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • Lentgh of stay ICU [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Length of stay - hospital [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • Other blood product administration [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • Hgb - arrival ICU [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Hgb - prior to Discharge [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Lowest post op Hgb [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Volume of crystalloid delivered in cardioplegia [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Fluid balance [ Time Frame: 30 d ] [ Designated as safety issue: No ]
  • Reoperation rate for bleeding [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Inotrope score [ Time Frame: 30 day ] [ Designated as safety issue: No ]
    Score incorporating amount and number of inotropes administered

  • Low output syndrome [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Troponin [ Time Frame: 24 hours post op ] [ Designated as safety issue: No ]
  • Infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Composite according to standardized definitions

  • intra-op Ventricular function [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    as determined by conductance catheter


Estimated Enrollment: 48
Study Start Date: August 2012
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Stacy OBlenes, Principal Investigator, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01623193     History of Changes
Other Study ID Numbers: ABC Trial
Study First Received: June 13, 2012
Last Updated: May 13, 2014
Health Authority: Canada:Capital Health Research Ethics Board

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

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

ClinicalTrials.gov processed this record on October 01, 2014