Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00470444
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2007-05-03
Brief Title:
Transfusion Triggers in Cardiac Surgery
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
Transfusion Triggers in Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TTRICS
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 Michaels 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
Detailed 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 11812 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None