Skip to main content
OpenTrials
Completed

NCT Number: NCT01623193

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital Health

Halifax, Nova Scotia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

All-blood cardioplegia

Other

The treatment group will receive all-blood cardioplegia for myocardial protection during surgery

Standard cardioplegia

Procedure

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

Primary outcomes

  1. Blood transfusion

    Time frame: 30 days

    Number of units of packed red blood cells transfused

  2. Intra-op diastolic function

    Time frame: day 1

    Left ventricular chamber stiffness constant measured by conductance catheter in the operating room

Secondary outcomes

  1. Mortality

    Time frame: 30 day

    Mortality

  2. Duration of Ventilation

    Time frame: 30 day

  3. Lentgh of stay ICU

    Time frame: 30 days

  4. Length of stay - hospital

    Time frame: 30 day

  5. Other blood product administration

    Time frame: 30 day

  6. Hgb - arrival ICU

    Time frame: day 1

  7. Hgb - prior to Discharge

    Time frame: 30 days

  8. Lowest post op Hgb

    Time frame: 30 days

  9. Volume of crystalloid delivered in cardioplegia

    Time frame: day 1

  10. Fluid balance

    Time frame: 30 d

  11. Reoperation rate for bleeding

    Time frame: 30 days

  12. Inotrope score

    Time frame: 30 day

    Score incorporating amount and number of inotropes administered

  13. Low output syndrome

    Time frame: 30 days

  14. Troponin

    Time frame: 24 hours post op

  15. Infection

    Time frame: 30 days

    Composite according to standardized definitions

  16. intra-op Ventricular function

    Time frame: day 1

    as determined by conductance catheter

Sponsors and collaborators

Lead sponsor

Pam Trenholm

Other

Registry information

Official study title

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

Acronym: ABC

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 19, 2012
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.