Comparison of Three Management Strategies for Post Cardiac Surgery Bleeding

NCT00188747 — Phase 4, Completed, 150 participants, University Health Network, Toronto

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Comparison of Three Management Strategies for Post Cardiac Surgery Coagulopathy.

RegistryNCT00188747
StatusCompleted
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment150
SponsorUniversity Health Network, Toronto (Other); collaborators: Anemia Institute for Research & Education
ConditionsHeart Disease, Coagulopathy
InterventionsThromboelastograph, Point of Care (Procedure)
Datesstart 2005-06-01, first posted 2005-09-16, last updated 2006-10-11
Locations1 site in Canada

Related Papers Related Patents Related Grants Related Experts
All trials for Heart Disease All trials for Coagulopathy All trials of Thromboelastograph, Point of Care

-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.

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+Arms and interventions

  • Thromboelastograph, Point of Care (Procedure)

+Outcome measures

Primary outcomes

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

Secondary outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to any

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)

+Locations (1)

FacilityCityCountryStatus
Toronto General Hospital, University Health NetworkToronto, OntarioCanada

+Investigators

  • Keyvan Karkouti, MD, Principal investigator, Toronto General Hospital, University Health Network