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

Sponsor

Stacy OBlenes (Other)

Overall Status

Unknown status

CT.gov ID

NCT01623193

Collaborator

(none)

Enrollment

Location

Arms

Study Details

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

Anticipated 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 :

Aug 1, 2012

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

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

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

Secondary Outcome Measures

Mortality [30 day]
Mortality
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 [30 day]
Score incorporating amount and number of inotropes administered
Low output syndrome [30 days]
Troponin [24 hours post op]
Infection [30 days]
Composite according to standardized definitions
intra-op Ventricular function [day 1]
as determined by conductance catheter

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).