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Completed

NCT Number: NCT06349551

Clot Formation and Coagulation Factors Consumption in the Clearing Fluid After Arterial Catheter Blood Sampling.

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes university hospital, Nantes, Loire-atlantique, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients of intensive care unit

Biological

Patients of intensive care unit having an arterial catheter undergoing arterial blood sampling

Primary outcomes

  1. Composite score of the coagulation activation over time in the clearing fluid during blood sampling from an arterial catheter

    Time frame: 5 minutes (T5)

    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

Secondary outcomes

  1. Concentration of prothrombin over time in the clearing fluid during blood sampling from an arterial catheter

    Time frame: 5 minutes (T5)

    Prothrombin time will be assayed at T0, T3 and T5

  2. Concentration of factor II over time in the clearing fluid during blood sampling from an arterial catheter

    Time frame: 5 minutes (T5)

    Factor II will be assayed at T0, T3 and T5

  3. Concentration of factor V over time in the clearing fluid during blood sampling from an arterial catheter

    Time frame: 5 minutes (T5)

    Factor V will be assayed at T0, T3 and T5

  4. Concentration of fibrin monomer over time in the clearing fluid during blood sampling from an arterial catheter

    Time frame: 5 minutes (T5)

    Fibrin monomers will be assayed at T0, T3 and T5

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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.

Acronym: SECU-BIO2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 5, 2024
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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