Comparison of Three Management Strategies for Post Cardiac Surgery Bleeding
Primary Purpose
Heart Disease, Coagulopathy
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Thromboelastograph, Point of Care
Sponsored by
About this trial
This is an interventional treatment trial for Heart Disease focused on measuring Coagulopathy, Cardiac Surgery, Point of Care, Monitoring
Eligibility Criteria
Inclusion Criteria: greater than 18 years no emergent complex cardiac surgery Exclusion Criteria: Isolated CABG Single valve surgery Pre-existing coagulopathy PTT>50's, INR>1.3 Severe Thrombocytopenia Platelet <100,000 Recent Antiplatelet drugs(Plavix within 7 days, Integrilin within 24 hours)
Sites / Locations
- Toronto General Hospital, University Health Network
Outcomes
Primary Outcome Measures
Units of blood products transfused in the first 24 hours post CPB.
Secondary Outcome Measures
Test cost, chest tube blood loss 24h; blood products in the postoperative period; modifications in transfusion that would have occurred if result from other group's tests were available; length of stay ICU and hospital; incidence of major complications.
Full Information
NCT ID
NCT00188747
First Posted
September 12, 2005
Last Updated
October 10, 2006
Sponsor
University Health Network, Toronto
Collaborators
Anemia Institute for Research & Education
1. Study Identification
Unique Protocol Identification Number
NCT00188747
Brief Title
Comparison of Three Management Strategies for Post Cardiac Surgery Bleeding
Official Title
Comparison of Three Management Strategies for Post Cardiac Surgery Coagulopathy.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
Collaborators
Anemia Institute for Research & Education
4. Oversight
5. Study Description
Brief Summary
Open-heart surgery frequently results in abnormal clotting, which in turn results in excessive blood loss and the need for transfusion of multiple blood products to patients and leads to adverse outcomes. Prompt identification of any clotting abnormalities after cardiac surgery reduces blood loss and blood product transfusion and may improve outcomes. Currently, however, this monitoring is dependent on standard laboratory-based tests of clotting that have a long turnaround time (30-45 min) and do not measure some important aspect of clotting. There are now other monitoring options that are carried out at patients' bedside, providing results more quickly than standard laboratory tests (within 2-5 minutes for some), and measure more aspects of clotting, providing more information on possible causes of any abnormalities. In this study, we will compare the cost-effectiveness of two of these newer monitoring techniques with standard laboratory-based tests by assigning 150 patients who will be undergoing open-heart surgery to one of the three monitoring techniques (50 patients will be assigned by chance to each group). In each group, an explicit algorithm based on the monitoring technique of that group will be used to guide all transfusion decisions. Between-group differences in number of units of blood products transfused (primary outcome), amount of blood loss, rate of adverse events, and cost of monitoring will be measured. The objective of the study is to determine which of the three methods is most cost-effective in terms of these outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Coagulopathy
Keywords
Coagulopathy, Cardiac Surgery, Point of Care, Monitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Thromboelastograph, Point of Care
Primary Outcome Measure Information:
Title
Units of blood products transfused in the first 24 hours post CPB.
Secondary Outcome Measure Information:
Title
Test cost, chest tube blood loss 24h; blood products in the postoperative period; modifications in transfusion that would have occurred if result from other group's tests were available; length of stay ICU and hospital; incidence of major complications.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
greater than 18 years
no emergent complex cardiac surgery
Exclusion Criteria:
Isolated CABG
Single valve surgery
Pre-existing coagulopathy PTT>50's, INR>1.3
Severe Thrombocytopenia Platelet <100,000
Recent Antiplatelet drugs(Plavix within 7 days, Integrilin within 24 hours)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keyvan Karkouti, MD
Organizational Affiliation
Toronto General Hospital, University Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
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Comparison of Three Management Strategies for Post Cardiac Surgery Bleeding
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