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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional d'Orléans

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Protected person (under guardianship or curatorship)

Person under court protection

Person deprived of liberty

Person not affiliated to the French social security

Trial design

Design model

Parallel

Treatments tested in this trial

  • catheter flushing techniques

    Procedure/Surgery

    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).

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: Sequence A, B, A, BExperimental treatment 1 intervention
Group B: Sequence A, B, B, AExperimental treatment 1 intervention
Group C: Sequence B, A, B, AExperimental treatment 1 intervention
Group D: Sequence B, A, A, BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Difference in anti-Xa activity values between the two sampling sites.

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.

Time frame
From inclusion to the four pairs of simultaneous blood samples collected assessed up to Day 28

Secondary outcomes

1

Equivalence of anti-Xa activity measurements between central venous catheter sampling using flush method A (5 mL syringe discard) and peripheral vein puncture.

Agreement limits of anti-Xa activity measurements between central venous catheter sampling using flush method A and peripheral vein puncture.

Time frame
From inclusion to the four pairs of simultaneous blood samples collected assessed up to Day 28
2

Equivalence of anti-Xa activity measurements between central venous catheter sampling using flush method B (5 mL vacuum tube discard) and peripheral vein puncture.

Agreement limits of anti-Xa activity measurements between central venous catheter sampling using flush method B and peripheral vein puncture. In both cases, the anti-Xa activity measured from the peripheral vein is considered the reference

Time frame
From inclusion to the four pairs of simultaneous blood samples collected assessed up to Day 28

Other outcomes

1

Types and durations of organ support therapies

Organ support requirements, including number of days on mechanical ventilation, renal replacement therapy, or extracorporeal membrane oxygenation (ECMO).

Time frame
From enrollment to Day 28 or discharge (whichever comes first)
2

Thromboembolic and bleeding complications

Description of thrombotic and bleeding complications during the ICU stay, with bleeding events graded according to ISTH severity criteria.

Time frame
From enrollment to Day 28 or discharge (whichever comes first)
3

Types of blood products transfused

Type of blood products transfused (red blood cells, frozen plasma, platelets) during the ICU stay will be recorded.

Time frame
From enrollment to Day 28 or discharge (whichever comes first)
4

Number of blood products transfused

Number of blood products transfused during the ICU stay.

Time frame
Day 28 or discharge (whichever comes first)

Sponsors and contacts

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