Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06349551
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-20
Brief Title:
Clot Formation and Coagulation Factors Consumption in the Clearing Fluid After Arterial Catheter Blood Sampling
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Clot Formation and Coagulation Factors Consumption Over Time in the Clearing Fluid After Arterial Catheter Blood Sampling in Critically Ill Adult Patients Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
SECU-BIO2
Brief Summary:
After blood sampling from an arterial catheter the reinjection of the clearing fluid a mixture of saline solution and blood is proposed to limit blood loss However the status of coagulation in this clearing liquid remains poorly documented
Detailed Description:
In the intensive care unit blood sampling is mainly performed through an arterial catheter radial or femoral artery In addition to continuous arterial pressure monitoring this provides an easy access to arterial blood without the need for venipuncture
It is standard practice to first clear the arterial sampling line before drawing blood for biological tests to prevent the blood sample from being diluted by the arterial catheters perfusion solution This clearing fluid ie a mixture of saline solution and blood is usually discarded It has been reported that the clearing fluid volume alone represents 24 to 30 of the total blood volume required for blood sampling
Devices for reinjecting this clearing fluid are already on the market The advantages of these devices include blood saving reduced risk of blood exposure reduced biological waste and lower infection rates associated with catheter handling The main drawback of these devices is their cost and the need for frequent replacement Moreover their impact on the decrease of blood transfusion remains unclear
Furthermore there are too few published data on the potential coagulation of clearing fluid reinjected into the patient nor the maximum time it can be safely reinjected
The aim of this study is to assess the activation of coagulation over time in the clearing fluid during arterial catheter blood sampling
It is standard practice to first clear the arterial sampling line before drawing blood for biological tests to prevent the blood sample from being diluted by the arterial catheters perfusion solution This clearing fluid ie a mixture of saline solution and blood is usually discarded It has been reported that the clearing fluid volume alone represents 24 to 30 of the total blood volume required for blood sampling
Devices for reinjecting this clearing fluid are already on the market The advantages of these devices include blood saving reduced risk of blood exposure reduced biological waste and lower infection rates associated with catheter handling The main drawback of these devices is their cost and the need for frequent replacement Moreover their impact on the decrease of blood transfusion remains unclear
Furthermore there are too few published data on the potential coagulation of clearing fluid reinjected into the patient nor the maximum time it can be safely reinjected
The aim of this study is to assess the activation of coagulation over time in the clearing fluid during arterial catheter blood sampling
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