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
- Conditions
- Anticoagulants and Bleeding Disorders
- Registration Number
- NCT07183605
- Lead Sponsor
- Centre Hospitalier Régional d'Orléans
- Brief 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.
- Detailed Description
Unfractionated heparin (UFH) is widely used in intensive care units (ICUs) and requires close monitoring, most commonly through the measurement of anti-Xa activity.
The reference method for anti-Xa monitoring involves blood sampling by peripheral vascular puncture. However, in ICU patients, peripheral access may be challenging or painful, and central venous catheters are often available and already used for UFH infusion. Sampling from these central lines could be a convenient alternative, but residual heparin in the catheter may contaminate the sample, leading to falsely elevated anti-Xa results.
The CASSANDRA study (Central catheter Anti-Xa Sampling Study for Accurate aNalysis and Reliable Dosage Assessment) is a prospective, monocentric, comparative study designed to assess whether anti-Xa activity levels obtained from central venous catheter samples are equivalent to those from peripheral vein samples.
To be eligible for inclusion, patients must already have a central venous catheter in place and require continuous intravenous unfractionated heparin administration through the distal lumen of the central venous catheter.
A three-way stopcock will be placed upstream of the infusion tubing to allow temporary interruption of UFH infusion during sampling.
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).
For each patient, four pairs of simultaneous blood samples will be collected, according to a randomized sequence alternating between methods A and B. In each pair, one sample will be drawn from the central venous catheter and the other from a fresh peripheral vein puncture (reference). All anti-Xa assays will be performed, but only the results from peripheral vein samples (reference method) will be made available to clinicians. Anti-Xa results from central venous catheter samples will remain blinded to the clinical team to avoid influencing patient management.
The primary outcome is the absolute difference in anti-Xa activity between central venous catheter samples (either method) and peripheral samples. Equivalence is defined as a mean difference not exceeding 0.05 IU/mL. Secondary outcomes include Bland-Altman agreement limits between each central method and the peripheral reference.
Results of this study may support the safe use of central venous sampling for routine anti-Xa monitoring in ICU patients, provided an appropriate flushing method is used.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Equivalence of anti-Xa activity measurements between central venous catheter sampling using flush method A (5 mL syringe discard) and peripheral vein puncture. From inclusion to the four pairs of simultaneous blood samples collected assessed up to Day 28 Agreement limits of anti-Xa activity measurements between central venous catheter sampling using flush method A and peripheral vein puncture.
Equivalence of anti-Xa activity measurements between central venous catheter sampling using flush method B (5 mL vacuum tube discard) and peripheral vein puncture. From inclusion to the four pairs of simultaneous blood samples collected assessed up to Day 28 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
Trial Locations
- Locations (1)
Chu Orleans
🇫🇷Orléans, France
Chu Orleans🇫🇷Orléans, FranceGregoire MULLER, PHPrincipal Investigator