Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405516
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-04-29
Brief Title:
Platelet Function After Cardiac Surgery
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Platelet Count and Function After Usage of Two Different Cell Saver Devices During Cardiac Surgery a Randomized Controlled Multi-center Equivalence Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
PLFICS
Brief Summary:
Intraoperative cell salvage is commonly used in cardiac surgery to reduce the administration of allogeneic red blood cells and thus improve the outcome for the patient When processing the salvaged blood however a large part of the patients plasma is washed out This is a disadvantage with regard to an optimal coagulation situation after cardiac surgery
There are currently various cell saver systems on the market According to the manufacturers the plasma is returned to the patient in different quantities as part of the processing procedure Thus it can be assumed that in addition to red blood cells platelets part of plasma are retransfused and contribute to an optimized coagulation Unfortunately there is a lack of studies in this regard in the cardiac surgery population
The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function
There are currently various cell saver systems on the market According to the manufacturers the plasma is returned to the patient in different quantities as part of the processing procedure Thus it can be assumed that in addition to red blood cells platelets part of plasma are retransfused and contribute to an optimized coagulation Unfortunately there is a lack of studies in this regard in the cardiac surgery population
The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function
Detailed Description:
None
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