Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188747
Status:
COMPLETED
Last Update Posted:
2006-10-11
First Post:
2005-09-12
Brief Title:
Comparison of Three Management Strategies for Post Cardiac Surgery Bleeding
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Comparison of Three Management Strategies for Post Cardiac Surgery Coagulopathy
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Anemia Institute 04-14 | None | None | None |