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

Condition(s) studied

Investigational drug(s) / intervention(s)

catheter flushing techniques: Two catheter flushing techniques will be compared: * Method A: A 5 mL flush performed with a syringe over 5 seconds. * Method B: A 5 mL flush using a vacuum tube (standard discard tube).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Difference in anti-Xa activity values between the two sampling sites. — From inclusion to the four pairs of simultaneous blood samples collected assessed up to Day 28
  Difference in anti-Xa activity values between the two sampling sites: central venous catheter with a 5 mL discard using either a syringe or a vacuum tube, versus peripheral vein puncture, the latter being considered the reference method. Equivalence is defined a priori as a mean absolute difference not exceeding 0.05 IU/mL of anti-Xa activity.

Trial sites (1)

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