Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550505
Status:
COMPLETED
Last Update Posted:
None
First Post:
2021-11-30
Brief Title:
Management of the Patient at High Risk Hemorrhagic in Cardiac Surgery by Monitoring Viscoelastic Hemostasis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation and Follow-up of a Protocol for the Management of the Patient at High Risk Hemorrhagic in Cardiac Surgery by Monitoring Viscoelastic Hemostasis
Status:
COMPLETED
Status Verified Date:
2024-08
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:
ELASTICC
Brief Summary:
Evaluation and following of a protocol using viscoelastic test for the management of high risk patients in cardiac surgery
Detailed Description:
Haemorragy is a frequent issue in cardiac surgery due to multiple contributing factors Excessive bleeding as well as transfusion are associated with increased morbidity and mortality
Haemostatic blood products Fibrinogen fresh frozen plasma platelets transfusion had historically been guided by routine coagulation tests aPTT PT platelets and fibrinogen However the delay Up to 60 minutes often leads to an empirical use of blood products in a context where clinical judgment is unreliable due to the multiples mechanisms contributing to haemostatic failure
Using viscoelastic tests VET in this context has several advantages
A quicker response with first results from 10 minutes
An overall evaluation of haemostatic from the clot formation to its dissolution
The use of VET has mainly been evaluated in cardiac surgery with several recent meta-analysis The use of transfusion algorithms based on VET is associated with less transfusions of red blood cell concentrates plasma and platelets and also with less mortality less re-interventions due to excessive bleeding and less post operative renal failure
These data led the international society for the study of hemostasis and thrombosis ISTH to recommend their use of VET in cardiac surgery In France the proposals of the peri operative hemostatis group of interest GIHP also support their use specifying that there is no unique consensual algorithm
Considering this the investigator established a transfusion algorithm based on the Quantra a viscoelastic device using sonorrheometry to guide transfusion in high-risk of bleeding cardiac surgery patients
Haemostatic blood products Fibrinogen fresh frozen plasma platelets transfusion had historically been guided by routine coagulation tests aPTT PT platelets and fibrinogen However the delay Up to 60 minutes often leads to an empirical use of blood products in a context where clinical judgment is unreliable due to the multiples mechanisms contributing to haemostatic failure
Using viscoelastic tests VET in this context has several advantages
A quicker response with first results from 10 minutes
An overall evaluation of haemostatic from the clot formation to its dissolution
The use of VET has mainly been evaluated in cardiac surgery with several recent meta-analysis The use of transfusion algorithms based on VET is associated with less transfusions of red blood cell concentrates plasma and platelets and also with less mortality less re-interventions due to excessive bleeding and less post operative renal failure
These data led the international society for the study of hemostasis and thrombosis ISTH to recommend their use of VET in cardiac surgery In France the proposals of the peri operative hemostatis group of interest GIHP also support their use specifying that there is no unique consensual algorithm
Considering this the investigator established a transfusion algorithm based on the Quantra a viscoelastic device using sonorrheometry to guide transfusion in high-risk of bleeding cardiac surgery patients
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