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Comparison of Three Management Strategies for Post Cardiac Surgery Bleeding

Comparison of Three Management Strategies for Post Cardiac Surgery Coagulopathy.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00188747
Enrollment
150
Registered
2005-09-16
Start date
2005-06-30
Completion date
Unknown
Last updated
2006-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulopathy, Heart Disease

Keywords

Coagulopathy, Cardiac Surgery, Point of Care, Monitoring

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.

Interventions

PROCEDUREThromboelastograph, Point of Care

Sponsors

Anemia Institute for Research & Education
CollaboratorOTHER
University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026