Comparison of Three Management Strategies for Post Cardiac Surgery Bleeding

NCT ID: NCT00188747

Last Updated: 2006-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30

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.

Conditions

Heart Disease; Coagulopathy

Keywords

Coagulopathy; Cardiac Surgery; Point of Care; Monitoring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Thromboelastograph, Point of Care

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anemia Institute for Research & Education

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Principal Investigators

Keyvan Karkouti, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital, University Health Network

Locations

Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

Anemia Institute #04-14

Identifier Type: -

Identifier Source: secondary_id

UHN REB 05-0054-B

Identifier Type: -

Identifier Source: org_study_id