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Completed

NCT Number: NCT00188747

Comparison of Three Management Strategies for Post Cardiac Surgery Bleeding

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Thromboelastograph, Point of Care

Procedure

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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Anemia Institute for Research & Education

Registry information

Official study title

Comparison of Three Management Strategies for Post Cardiac Surgery Coagulopathy.

Important dates

Study start
2005
First posted
Sep 16, 2005
Registry last updated
Oct 11, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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