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
Recruiting now · Not applicable
Conditions studied: Anticoagulants and Bleeding Disorders
In brief
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.
Key facts
- Study ID
- NCT07183605
- Run by
- Centre Hospitalier Régional d'Orléans
- People needed
- 30
- Starts
- 2025-09-22
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Chu Orleans — Orléans, France (enrolling)
Full record on ClinicalTrials.gov
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