Comparison of Three Management Strategies for Post Cardiac Surgery Bleeding

NCT00188747 | Completed Phase 4

• 2 other identifiers: UHN REB 05-0054-BAnemia Institute #04-14
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Units of blood products transfused in the first 24 hours post CPB.

Secondary Outcomes (1)

• 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.

Interventions

Thromboelastograph, Point of Care PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• greater than 18 years
• no emergent complex cardiac surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Anemia Institute for Research & Education: collaborator

Study Sites (1)

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Heart Diseases; Hemostatic Disorders

Interventions

Point-of-Care Systems

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Vascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Hospital Information Systems; Hospital Administration; Health Facility Administration; Organization and Administration; Health Services Administration; Management Information Systems; Patient Care Management

Study Officials

• Keyvan Karkouti, MD

  Toronto General Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: June 1, 2005
• Last Updated: October 11, 2006

Record last verified: 2006-04

Locations

CA (1)