Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637943
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Comparison of Time Taken to Diagnose Intraoperative Coagulopathies Using VET and SCL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Time Taken for Diagnosing Intraoperative Coagulopathies Point-of-care Viscoelastic Tests Vs Standard Central Laboratory Tests
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study is a prospective multi-center observational trial comparing the time it takes to diagnose coagulopathies due to intraoperative bleeding using point-of-care POC viscoelastic tests or standard central laboratory tests SCL tests
Detailed Description:
The present study is a prospective multi-center observational trial comparing the time for diagnosing coagulopathies due to intraoperative bleeding using POC viscoelastic tests such as rotational thromboelastometry ROTEM and thromboelastography TEG and standard central laboratory tests SCL test such as PT-INR aPTT s-fibrinogen level platelet count
The study will be performed during surgeries that are expected to entail a moderate to severe amount of bleeding and warrant the use of either POC viscoelastic tests SCL tests or both to determine the possible association of coagulopathy
The tests will be conducted when an intraoperative condition requires identifying possible associations of coagulopathies during and after surgical bleeding The test results will prompt appropriate coagulation management
The primary objective is to compare the diagnosis time for intraoperative coagulopathy upon using the POC viscoelastic test or SCL test The time will be defined as the time lapsed from obtaining a blood sample for the POC viscoelastic test or SCL test to acknowledging the test results
Researchers hypothesized that using POC viscoelastic tests would shorten the time for diagnosis compared to SCL tests
The study will be performed during surgeries that are expected to entail a moderate to severe amount of bleeding and warrant the use of either POC viscoelastic tests SCL tests or both to determine the possible association of coagulopathy
The tests will be conducted when an intraoperative condition requires identifying possible associations of coagulopathies during and after surgical bleeding The test results will prompt appropriate coagulation management
The primary objective is to compare the diagnosis time for intraoperative coagulopathy upon using the POC viscoelastic test or SCL test The time will be defined as the time lapsed from obtaining a blood sample for the POC viscoelastic test or SCL test to acknowledging the test results
Researchers hypothesized that using POC viscoelastic tests would shorten the time for diagnosis compared to SCL tests
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