Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05875272
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2023-05-16
Brief Title:
Interchangeability of Arterial Coagulation and Venous Coagulation in the Context of Cardiac Surgeries Under Cardiopulmonary Bypass Using the DMDiv Hemochron Signature Elite
Sponsor:
Centre Hospitalier Universitaire Amiens
Organization:
Centre Hospitalier Universitaire Amiens
Study Overview
Official Title:
Prospective Monocentric Study of the Interchangeability of Arterial Coagulation and Venous Coagulation in the Context of Cardiac Surgeries Under Cardiopulmonary Bypass Using the DMDiv Hemochron Signature Elite
Status:
RECRUITING
Status Verified Date:
2024-02
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:
COAGAV
Brief Summary:
Adequate coagulation measured using activated clotting ACT is important during vascular and cardiac surgeries Unfractionated heparin is the most common anticoagulant used For point of care testing under supervision of biology department the investigators use Hemochron Signature EliteHSE Werfen-Barcelona Spain to determine coagulation during cardiac surgery under Cardiopulmonary Bypass CPB with arterial or venous blood The dosage of heparin varies according to this result throughout the CPB On the Connect Manager software Livanova Italy which records all the data of a CPB it is mandatory to inform during an ACT the sampling site in arterial or venous The chemical compositions of arterial blood and venous blood are different O2 Co2 Even if the qualities of coagulation in vivo are identical what happens when they are chemically analyzed using the medical device HSE Can we trust the results of this device to secure anticoagulation under CPB Are the results affected by the sampling site The objective of this study is to compare the reliability of hemostasis control during cardiac surgery under cardiopulmonary bypass for both venous and arterial blood Effective and controllable anticoagulation is mandatory during cardiac surgeries under extracorporeal circulation The monitoring of the effectiveness of heparin is carried out in our center using the Hemochron Signature Elite HSE medical device which measures the ACT Activated Clotting Time There is no comparative study between hemostasis of venous blood versus arterial blood with this point of care device
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?:
None
Is an FDA AA801 Violation?:
None