Clot Formation and Coagulation Factors Consumption in the Clearing Fluid After Arterial Catheter Blood Sampling. (SECU-BIO2)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care Units; Arterial Lines
• Intervention / Treatment: Biological: Patients of intensive care unit

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

• Study Type: Observational
• Enrollment (Estimated): 211

Contacts and Locations

• Study Contact: Name: Jérôme DAUVERGNE; Phone Number: 02.40.16.52.89; Email: jerome.dauvergne@chu-nantes.fr

Study Locations

• France
  • Saint-Nazaire, France, 44606
    • Not yet recruiting
    • Hospital center
    • Contact: Damien Muller, Dr; Phone Number: 02 72 27 89 89; Email: dmuller.med@gmail.com
  • Loire-atlantique
    • Nantes, Loire-atlantique, France, 44093
      • Recruiting
      • Nantes University Hospital
      • Contact: Jerôme Dauvergne; Phone Number: +33240165289; Email: jerome.dauvergne@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adult patient with arterial catheter (radial or femoral).

Description

Inclusion Criteria:

• Patient older than 18 years old
• Admitted to the ICU
• With a radial or femoral arterial catheter
• Requiring blood sampling

Exclusion Criteria:

• Presence of a non-standard extension line: any tubing other than an arterial line intended for this purpose.
• Constitutional or acquired hemorrhagic disease,
• Major biological thrombophilia (anti-phospholipid syndrome, homozygous mutation of factor II or V, protein C, S or antithrombin deficiency),
• Thromboembolic event in progress or < 6 months,
• Bacteremia within the last 48 hours,
• Previous study participation,
• Pregnant or breast-feeding patient
• Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment
• Patient with no health insurance
• Patient under guardianship

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite score of the coagulation activation over time in the clearing fluid during blood sampling from an arterial catheter	Activation of coagulation in the clearing fluid will be assessed by a composite criterion defined by: the presence of a macroscopic clot (binary YES or NO criterion) or; fibrinogen consumption (binary YES or NO criterion). Fibrinogen consumption will be classified as YES when its decrease, compared with the reference value measured at T0, is greater than the known technical variability of the assay method	5 minutes (T5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of prothrombin over time in the clearing fluid during blood sampling from an arterial catheter	Prothrombin time will be assayed at T0, T3 and T5	5 minutes (T5)
Concentration of factor II over time in the clearing fluid during blood sampling from an arterial catheter	Factor II will be assayed at T0, T3 and T5	5 minutes (T5)
Concentration of factor V over time in the clearing fluid during blood sampling from an arterial catheter	Factor V will be assayed at T0, T3 and T5	5 minutes (T5)
Concentration of fibrin monomer over time in the clearing fluid during blood sampling from an arterial catheter	Fibrin monomers will be assayed at T0, T3 and T5	5 minutes (T5)

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Estimated): March 20, 2025
• Study Completion (Estimated): March 20, 2025

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RC23_0586

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No