Clinical trial NCT01623193: The ABC Trial Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery? A Single Centre Pilot Study
Official title: The ABC Trial - Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Valvular Heart Disease
Keywords: Cardioplegia
Blood transfusion
Cardiac function
Myocardial edema
Coronary artery disease
Valve disease
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 48
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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).

Primary outcomes:
measure: Blood transfusion
timeFrame: 30 days
measure: Intra-op diastolic function
timeFrame: day 1
Secondary outcomes:
measure: Mortality
timeFrame: 30 day
measure: Duration of Ventilation
timeFrame: 30 day
measure: Lentgh of stay ICU
timeFrame: 30 days
measure: Length of stay - hospital
timeFrame: 30 day
measure: Other blood product administration
timeFrame: 30 day
measure: Hgb - arrival ICU
timeFrame: day 1
measure: Hgb - prior to Discharge
timeFrame: 30 days
measure: Lowest post op Hgb
timeFrame: 30 days
measure: Volume of crystalloid delivered in cardioplegia
timeFrame: day 1
measure: Fluid balance
timeFrame: 30 d
measure: Reoperation rate for bleeding
timeFrame: 30 days
measure: Inotrope score
timeFrame: 30 day
measure: Low output syndrome
timeFrame: 30 days
measure: Troponin
timeFrame: 24 hours post op
measure: Infection
timeFrame: 30 days
measure: intra-op Ventricular function
timeFrame: day 1
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Capital Health
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Stacy O'Blenes, MD
role: PRINCIPAL_INVESTIGATOR
References: