Coronary Artery DiseaseABCNCT01623193
The ABC Trial Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery? A Single Centre Pilot Study
A study testing All-blood cardioplegia and Standard cardioplegia in people with Coronary Artery Disease and Valvular Heart Disease, run by Pam Trenholm at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Coronary Artery Disease, Valvular Heart Disease
- What is being tested?
- All-blood cardioplegia and Standard cardioplegia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 23 Apr 2012to 27 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Being tested
- All-blood cardioplegia, Standard cardioplegia
- Keywords
- Cardioplegia, Blood transfusion, Cardiac function, Myocardial edema, Coronary artery disease, Valve disease
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All-blood cardioplegiaOther
The treatment group will receive all-blood cardioplegia for myocardial protection during surgery
Standard cardioplegiaProcedure or surgery
This arm will receive standard 4:1 cardioplegia for myocardial protection during surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients receive standard 4:1 cardioplegia for myocardial protection during cardiac surgery Receives: Procedure: Standard cardioplegia |
| Treatment | Experimental | Patients receive all-blood cardiolpegia for myocardial protection during surgery Receives: Other: All-blood cardioplegia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood transfusion
Number of units of packed red blood cells transfused
Measured: 30 days
Intra-op diastolic function
Left ventricular chamber stiffness constant measured by conductance catheter in the operating room
Measured: day 1
Secondary outcomes (16)
Mortality
Mortality
Measured: 30 day
Duration of Ventilation
Measured: 30 day
Lentgh of stay ICU
Measured: 30 days
Length of stay - hospital
Measured: 30 day
Other blood product administration
Measured: 30 day
Hgb - arrival ICU
Measured: day 1
Hgb - prior to Discharge
Measured: 30 days
Lowest post op Hgb
Measured: 30 days
Volume of crystalloid delivered in cardioplegia
Measured: day 1
Fluid balance
Measured: 30 d
Reoperation rate for bleeding
Measured: 30 days
Inotrope score
Score incorporating amount and number of inotropes administered
Measured: 30 day
Low output syndrome
Measured: 30 days
Troponin
Measured: 24 hours post op
Infection
Composite according to standardized definitions
Measured: 30 days
intra-op Ventricular function
as determined by conductance catheter
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study start23 Apr 2012
- Primary completion27 May 2016
- Study completion27 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pam Trenholm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pam Trenholm, Nova Scotia Health Authority
- Investigators
- Stacy O'Blenes, MD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623193
- Sponsor's protocol ID
- ABC Trial
- Acronym
- ABC
- Status last verified
- Oct 2022
- First submitted
- 13 Jun 2012
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ABC Trial - Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01623193
- Acronym / sponsor ID
- ABC / ABC Trial
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Keywords
- Cardioplegia, Blood transfusion, Cardiac function, Myocardial edema, Coronary artery disease, Valve disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Pam TrenholmUniversity, hospital or other
- Study start
- 23 Apr 2012 (actual)
- Primary completion
- 27 May 2016 (actual)
- Study completion
- 27 May 2016 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Standard cardioplegiaPatients receive standard 4:1 cardioplegia for myocardial protection during cardiac surgery |
| Treatment | Experimental | Other: All-blood cardioplegiaPatients receive all-blood cardiolpegia for myocardial protection during surgery |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- reoperation,
- endocarditis,
- dialysis dependant renal failure,
- pre-operative ECMO or LVAD support,
- contraindication to blood transfusion (ie. Jehovah's Witness), and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All-blood cardioplegiaThe treatment group will receive all-blood cardioplegia for myocardial protection during surgery | Other | Treatment |
| Standard cardioplegiaThis arm will receive standard 4:1 cardioplegia for myocardial protection during surgery | Procedure or surgery | Control |
Primary outcome
Blood transfusion
Time frame: 30 days
Number of units of packed red blood cells transfused
Intra-op diastolic function
Time frame: day 1
Left ventricular chamber stiffness constant measured by conductance catheter in the operating room
16 secondary outcomes
Mortality
Time frame: 30 day
Duration of Ventilation
Time frame: 30 day
Lentgh of stay ICU
Time frame: 30 days
Length of stay - hospital
Time frame: 30 day
Other blood product administration
Time frame: 30 day
Hgb - arrival ICU
Time frame: day 1
Hgb - prior to Discharge
Time frame: 30 days
Lowest post op Hgb
Time frame: 30 days
Volume of crystalloid delivered in cardioplegia
Time frame: day 1
Fluid balance
Time frame: 30 d
Reoperation rate for bleeding
Time frame: 30 days
Inotrope score
Time frame: 30 day
Low output syndrome
Time frame: 30 days
Troponin
Time frame: 24 hours post op
Infection
Time frame: 30 days
intra-op Ventricular function
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy O'Blenes, MD principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All-blood cardioplegia and Standard cardioplegia in people with Coronary Artery Disease and Valvular Heart Disease, run by Pam Trenholm at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood transfusion (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.