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

NCT06349551 | Completed

• 1 other identifier: RC23_0586
• Study Type: observational
• Target: 213
• Locations: 1 country
• Sites: 2

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.

Conditions

Intensive Care Units; Arterial Lines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  5 minutes (T5)

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

  5 minutes (T5)

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

  5 minutes (T5)

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

  5 minutes (T5)

Interventions

Patients of intensive care unit BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patient with arterial catheter (radial or femoral).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

Nantes university hospital

Nantes, Loire-atlantique, 44093, France

Location

Hospital center

Saint-Nazaire, 44606, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 5, 2024
• Study Start: April 16, 2024
• Primary Completion: May 21, 2025
• Study Completion: May 21, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

FR (2)