Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT06349551
Status:
COMPLETED
Last Update Posted:
2025-05-25
First Post:
2024-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clot Formation and Coagulation Factors Consumption in the Clearing Fluid After Arterial Catheter Blood Sampling.
Sponsor:
Nantes University Hospital
Organization:
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:
COMPLETED
Status Verified Date:
2025-05
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 catheter's perfusion solution. This clearing fluid (i.e., 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 catheter's perfusion solution. This clearing fluid (i.e., 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?: