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Comparison of Three Management Strategies for Post Cardiac Surgery Bleeding

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00188747
First Posted: September 16, 2005
Last Update Posted: October 11, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Anemia Institute for Research & Education
Information provided by:
University Health Network, Toronto
  Purpose
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.

Condition Intervention Phase
Heart Disease Coagulopathy Procedure: Thromboelastograph, Point of Care Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Comparison of Three Management Strategies for Post Cardiac Surgery Coagulopathy.

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

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.

Estimated Enrollment: 150
Study Start Date: June 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188747


Locations
Canada, Ontario
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Anemia Institute for Research & Education
Investigators
Principal Investigator: Keyvan Karkouti, MD Toronto General Hospital, University Health Network
  More Information

ClinicalTrials.gov Identifier: NCT00188747     History of Changes
Other Study ID Numbers: UHN REB 05-0054-B
Anemia Institute #04-14
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: October 11, 2006
Last Verified: April 2006

Keywords provided by University Health Network, Toronto:
Coagulopathy
Cardiac Surgery
Point of Care
Monitoring

Additional relevant MeSH terms:
Heart Diseases
Blood Coagulation Disorders
Hemostatic Disorders
Cardiovascular Diseases
Hematologic Diseases
Vascular Diseases
Hemorrhagic Disorders