Transfusion Triggers in Cardiac Surgery

Cardiac Surgery Clinical Trial

— TTRICS  

Official title:

Transfusion Triggers in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470444
• Other study ID #: REB 06-185
• Status: Completed
• Phase: N/A
• First received: May 3, 2007
• Last updated: July 30, 2015
• Start date: December 2006
• Est. completion date: May 2009

Study information

• Verified date: November 2008
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

The optimal hemoglobin concentrations for transfusion in the perioperative setting in patients having cardiac surgery have not been established, and red cell transfusion rates for these patients are high. In a recent retrospective study of seven Canadian centres, which included 11,812 cardiac surgical patients, 44% of patients received one or more red cell units, and the range of patients transfused was 28% to 60%. As morbidity and mortality may be dependent on the severity of anemia and administration of transfusions, it is essential to determine at what hemoglobin concentration physicians should be transfusing these patients, particularly because the efficacy of transfusion has not been established. However, as any definitive trial will require thousands of patients, and as there is variability in transfusion practices, preliminary studies need to be completed to ensure the feasibility of adherence to proposed transfusion strategies. This pilot study is the first of two pilot trials designed to address the question of optimum hemoglobin concentrations for transfusion in patients having cardiac surgery prior to undertaking a definitive randomized controlled trial. The purpose of this study is to determine adherence to transfusion strategies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Care Score of 3/4 or age >/= 80

• Signed informed consent

Exclusion Criteria:

• Patients who refuse participation

• Unable to or refuse blood products

• Involved in an autologous pre-donation program

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Procedure:
• Transfusion with Red Blood Cells
Units of donated Red blood cells

Biological:
• 1 unit of donated red blood cells
Units of red blood cells
• 1 unit of donated red blood cells
Units of donated red blood cells

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Canadian Blood Services

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

Hébert 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. Erratum in: N Engl J Med 1999 Apr 1;340(13):1056. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	Yes