Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07183605

Comparison of Heparin Anti-Xa Activity From Central Venous Catheter Samples Using a 5 mL Syringe Flush or a Vacuum Tube Flush Versus Peripheral Vein Samples in ICU Patients

Led by Centre Hospitalier Régional d'Orléans · Updated on 2025-11-25

30

Participants Needed

1

Research Sites

53 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal is to investigate whether blood samples drawn from a central venous catheter can provide reliable measurements of unfractionated heparin (UFH) anti-Xa activity, compared to the standard method of peripheral vein puncture, in intensive care unit (ICU) patients receiving continuous intravenous UFH. To evaluate the reliability of central venous blood sampling, the study will compare anti-Xa activity levels obtained simultaneously from two different types of blood draws: one from a peripheral vein (reference method), and the other from the central line using one of two flushing techniques. The two central flushing techniques being studied are: * A 5 mL syringe flush performed over 5 seconds, followed by blood collection. * A vacuum tube flush that draws and discards 5 mL of blood, followed by blood collection. Each patient will undergo four pairs of simultaneous blood draws, using both central techniques in a randomized sequence. The main objective is to assess whether the anti-Xa levels from central samples are equivalent to those from peripheral vein puncture, with a predefined margin of equivalence of ±0.05 IU/mL. Findings from this study may support the use of central venous catheters for routine anti-Xa monitoring in ICU patients, potentially avoiding painful or technically difficult peripheral vein punctures.

CONDITIONS

Official Title

Comparison of Heparin Anti-Xa Activity From Central Venous Catheter Samples Using a 5 mL Syringe Flush or a Vacuum Tube Flush Versus Peripheral Vein Samples in ICU Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Person (or support person/relative if unable to do so) who has agreed to participate in the study
  • 18 years of age or older
  • Hospitalized in intensive care medicine
  • Having a central venous catheter with at least three lumens (internal jugular, subclavian or femoral) already in place
  • Receiving continuous intravenous unfractionned heparin, with target Anti-Xa activity between 0.3 and 0.7 IU/ml.
Not Eligible

You will not qualify if you...

  • Protected person (under guardianship or curatorship)
  • Person under court protection
  • Person deprived of liberty
  • Person not affiliated to the French social security
  • Pregnant or breast-feeding woman

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chu Orleans

Orléans, France, 45067

Actively Recruiting

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Research Team

G

Gregoire MULLER, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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