Comparison of Three Management Strategies for Post Cardiac Surgery Bleeding

Heart Disease Clinical Trial

Official title:

Comparison of Three Management Strategies for Post Cardiac Surgery Coagulopathy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188747
• Other study ID #: UHN REB 05-0054-B
• Secondary ID: Anemia Institute
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: October 10, 2006
• Start date: June 2005

Study information

• Verified date: April 2006
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulopathy
• Heart Disease
• Hemostatic Disorders

Intervention

Procedure:
• Thromboelastograph, Point of Care

Locations

Country	Name	City	State
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Anemia Institute for Research & Education

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Units of blood products transfused in the first 24 hours post CPB.
Secondary	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.