Clinical Trial

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

Study acronym: CASSANDRA
Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-18.
Status change: Not Yet Recruiting → Recruiting 2025-11-24
Trial Details
NCT Number NCT07183605
Lead Sponsor Centre Hospitalier Régional d'Orléans
Conditions Anticoagulants and Bleeding Disorders
Enrollment 30 participants
Start Date 2025-09-22
Primary Completion 2026-09 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2025-11-25