NCT07183605 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
| NCT ID | NCT07183605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Régional d'Orléans |
| Condition | Anticoagulants and Bleeding Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-22 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-09-22 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Gregoire MULLER, Dr
PRINCIPAL INVESTIGATOR
CHU Orléans
Frequently Asked Questions
Who can join the NCT07183605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anticoagulants and Bleeding Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07183605 currently recruiting?
Yes, NCT07183605 is actively recruiting participants. Contact the research team at gregoire.muller@chu-orleans.fr for enrollment information.
Where is the NCT07183605 trial being conducted?
This trial is being conducted at Orléans, France.
Who is sponsoring the NCT07183605 clinical trial?
NCT07183605 is sponsored by Centre Hospitalier Régional d'Orléans. The principal investigator is Gregoire MULLER, Dr at CHU Orléans. The trial plans to enroll 30 participants.