Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07183605

Central Catheter Anti-Xa Sampling Study for Accurate aNalysis and Reliable Dosage Assessment

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

30

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether blood samples drawn from a central venous catheter can reliably measure 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. The study aims to determine if central venous catheter sampling could be a less painful and more convenient alternative for monitoring anti-Xa activity, which is important for safe UFH dosing in ICU patients. The study compares two flushing techniques used in central venous catheter blood sampling: Method A involves a 5 mL syringe flush performed over 5 seconds, and Method B uses a 5 mL vacuum tube flush that discards blood before collection. Each patient undergoes four pairs of simultaneous blood draws, alternating between the two flushing methods in a randomized sequence. One sample in each pair is collected from the central catheter and the other from a peripheral vein, which serves as the reference for comparison. Participants will have their anti-Xa activity levels measured from both central and peripheral samples, but only the peripheral results will be shared with clinicians. The main outcome is the difference in anti-Xa activity between the two sampling sites, with equivalence defined as a mean difference within ±0.05 IU/mL. Secondary outcomes assess agreement limits between methods. Blood draws occur up to Day 28 after inclusion. The study may support using central catheters for routine anti-Xa monitoring if reliable results are confirmed, reducing the need for peripheral vein punctures.

CONDITIONS

Brief 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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 28 days

Participants undergo blood sampling to compare anti-Xa activity levels from central venous catheter samples using two different flushing methods versus peripheral vein samples.

4 paired blood sampling visits

Trial Site Locations

Total: 1 location

1

Chu Orleans

Orléans, France, 45067

Actively Recruiting

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Research Team

G

Gregoire MULLER, Dr

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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