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

The ABC Trial - Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Valvular Heart Disease
• Intervention / Treatment: Procedure: Standard cardioplegia; Other: All-blood cardioplegia

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Capital Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood transfusion	Number of units of packed red blood cells transfused	30 days
Intra-op diastolic function	Left ventricular chamber stiffness constant measured by conductance catheter in the operating room	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality	30 day
Duration of Ventilation		30 day
Lentgh of stay ICU		30 days
Length of stay - hospital		30 day
Other blood product administration		30 day
Hgb - arrival ICU		day 1
Hgb - prior to Discharge		30 days
Lowest post op Hgb		30 days
Volume of crystalloid delivered in cardioplegia		day 1
Fluid balance		30 d
Reoperation rate for bleeding		30 days
Inotrope score	Score incorporating amount and number of inotropes administered	30 day
Low output syndrome		30 days
Troponin		24 hours post op
Infection	Composite according to standardized definitions	30 days
intra-op Ventricular function	as determined by conductance catheter	day 1

Collaborators and Investigators

• Sponsor: Pam Trenholm
• Investigators: Principal Investigator: Stacy O'Blenes, MD, Dalhousie University

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2012
• Primary Completion (Actual): May 27, 2016
• Study Completion (Actual): May 27, 2016

Study Registration Dates

• First Submitted: June 13, 2012
• First Submitted That Met QC Criteria: June 15, 2012
• First Posted (Estimate): June 19, 2012

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Coronary artery disease; Cardiac function; Valve disease; Cardioplegia; Blood transfusion; Myocardial edema
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Valve Diseases
• Other Study ID Numbers: ABC Trial