Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06328647
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-03-08
Brief Title:
Quantra Point-of-Care Hemostasis Monitoring
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Quantra Point-of-Care Hemostasis Monitoring and Perioperative Blood and Blood Component Transfusion During High-Risk Complex Cardiac Surgery A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-10
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:
QUANTRA
Brief Summary:
The investigators will test the hypothesis that utilization of a blood and blood component transfusion algorithm guided by the POC Quantra QPlus System in patients undergoing complex cardiac surgery will reduce RBC plasma cryoprecipitate and platelet transfusion during surgery and the first 12 postoperative hours compared to standard of care central laboratory transfusion monitoring at the primary anesthesia providers discretion
Detailed Description:
The Investigators propose a randomized control trial to assess patients scheduled for aortic surgery or high-risk cardiac surgery requiring cardiopulmonary bypass
Patients will be randomized 11 to routine care or POC Quantra QPlus System The total number of blood and blood component transfusions including RBC plasma cryoprecipitate and platelets during and after cardiac surgery until 12 hours after ICU arrival will be analyzed between the groups
Patients will be randomized 11 to routine care or POC Quantra QPlus System The total number of blood and blood component transfusions including RBC plasma cryoprecipitate and platelets during and after cardiac surgery until 12 hours after ICU arrival will be analyzed between the groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None