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

Coronary Artery Disease Clinical Trial

— ABC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623193
• Other study ID #: ABC Trial
• Status: Completed
• Phase: N/A
• Start date: April 23, 2012
• Est. completion date: May 27, 2016

Study information

• Verified date: October 2022
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 27, 2016
• Est. primary completion date: May 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Heart Valve Diseases
• Myocardial Ischemia
• Valvular Heart Disease

Intervention

Other:
• All-blood cardioplegia
The treatment group will receive all-blood cardioplegia for myocardial protection during surgery

Procedure:
• Standard cardioplegia
This arm will receive standard 4:1 cardioplegia for myocardial protection during surgery

Locations

Country	Name	City	State
Canada	Capital Health	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Pam Trenholm

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood transfusion	Number of units of packed red blood cells transfused	30 days
Primary	Intra-op diastolic function	Left ventricular chamber stiffness constant measured by conductance catheter in the operating room	day 1
Secondary	Mortality	Mortality	30 day
Secondary	Duration of Ventilation		30 day
Secondary	Lentgh of stay ICU		30 days
Secondary	Length of stay - hospital		30 day
Secondary	Other blood product administration		30 day
Secondary	Hgb - arrival ICU		day 1
Secondary	Hgb - prior to Discharge		30 days
Secondary	Lowest post op Hgb		30 days
Secondary	Volume of crystalloid delivered in cardioplegia		day 1
Secondary	Fluid balance		30 d
Secondary	Reoperation rate for bleeding		30 days
Secondary	Inotrope score	Score incorporating amount and number of inotropes administered	30 day
Secondary	Low output syndrome		30 days
Secondary	Troponin		24 hours post op
Secondary	Infection	Composite according to standardized definitions	30 days
Secondary	intra-op Ventricular function	as determined by conductance catheter	day 1