NCT00470444

Brief Summary

A high proportion of patients having cardiac surgery receive red cell transfusions. Yet, the investigators do not know whether transfusions are beneficial and they may be associated with harm. It is thus important to determine when a transfusion is required. The investigators will conduct a small pilot study at St. Michael's Hospital to address this issue. Patients having cardiac surgery will be allocated to one of two transfusion strategies with endpoints being compliance with the transfusion strategy and clinical outcome. The results of this study will be used to design a large definitive multicentered trial of these two transfusion strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2006

Typical duration for not_applicable

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

December 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

July 31, 2015

Status Verified

November 1, 2008

Enrollment Period

2.3 years

First QC Date

May 3, 2007

Last Update Submit

July 30, 2015

Conditions

Cardiac Surgery

Keywords

Cardiac SurgeryTransfusion MedicineCardiac Anesthesia Risk Evaluation (CARE) Score of 3 or 4(Dupuis J-Y et al, Anesthesiology 2001;94: 194-204)

Outcome Measures

Primary Outcomes (1)

  • Overall adherence to the transfusion strategies defined as adherence to the transfusion strategies in 90% of patients in more than 90% of their days in hospital.

    Day of surgery through to hospital discharge.

Secondary Outcomes (1)

  • 1) enrollment rates 2) proportion of missing data 3) indicators for hypoxemia 4) mean number of red cell units used 5) clinical outcomes

    Day of surgery through to hospital discharge

Study Arms (2)

1

ACTIVE COMPARATOR

Liberal transfusion strategy

Procedure: Transfusion with Red Blood CellsBiological: 1 unit of donated red blood cells

2

ACTIVE COMPARATOR

Restrictive transfusion strategy

Biological: 1 unit of donated red blood cells

Interventions

Transfusion with Red Blood CellsPROCEDURE

Units of donated Red blood cells

1
1 unit of donated red blood cellsBIOLOGICAL

Units of red blood cells

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Care Score of 3/4 or age \>/= 80
  • Signed informed consent

You may not qualify if:

  • Patients who refuse participation
  • Unable to or refuse blood products
  • Involved in an autologous pre-donation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (5)

  • Dupuis JY, Wang F, Nathan H, Lam M, Grimes S, Bourke M. The cardiac anesthesia risk evaluation score: a clinically useful predictor of mortality and morbidity after cardiac surgery. Anesthesiology. 2001 Feb;94(2):194-204. doi: 10.1097/00000542-200102000-00006.

    PMID: 11176081BACKGROUND

  • Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. doi: 10.1056/NEJM199902113400601.

    PMID: 9971864BACKGROUND

  • Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

    PMID: 41114449DERIVED

  • Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

    PMID: 34932836DERIVED

  • Shehata N, Burns LA, Nathan H, Hebert P, Hare GM, Fergusson D, Mazer CD. A randomized controlled pilot study of adherence to transfusion strategies in cardiac surgery. Transfusion. 2012 Jan;52(1):91-9. doi: 10.1111/j.1537-2995.2011.03236.x. Epub 2011 Jul 25.

    PMID: 21790621DERIVED

MeSH Terms

Interventions

Blood TransfusionErythrocyte Count

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsBlood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • David Mazer, MD

    St. Michael's Hospital, University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 7, 2007

Study Start

December 1, 2006

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

July 31, 2015

Record last verified: 2008-11

Locations

CA(1)