NCT01623193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2016

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

4.1 years

First QC Date

June 13, 2012

Last Update Submit

October 26, 2022

Conditions

Coronary Artery DiseaseValvular Heart Disease

Keywords

CardioplegiaBlood transfusionCardiac functionMyocardial edemaCoronary artery diseaseValve disease

Outcome Measures

Primary Outcomes (2)

  • Blood transfusion

    Number of units of packed red blood cells transfused

    30 days

  • Intra-op diastolic function

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

    day 1

Secondary Outcomes (16)

  • Mortality

    30 day

  • Duration of Ventilation

    30 day

  • Lentgh of stay ICU

    30 days

  • Length of stay - hospital

    30 day

  • Other blood product administration

    30 day

  • +11 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients receive standard 4:1 cardioplegia for myocardial protection during cardiac surgery

Procedure: Standard cardioplegia

Treatment

EXPERIMENTAL

Patients receive all-blood cardiolpegia for myocardial protection during surgery

Other: All-blood cardioplegia

Interventions

All-blood cardioplegiaOTHER

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

Treatment
Standard cardioplegiaPROCEDURE

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

Control

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Health

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Coronary Artery DiseaseHeart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Stacy O'Blenes, MD

    Dalhousie University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 19, 2012

Study Start

April 23, 2012

Primary Completion

May 27, 2016

Study Completion

May 27, 2016

Last Updated

October 28, 2022

Record last verified: 2022-10

Locations

CA(1)