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

NCT07183605 | Recruiting

• 1 other identifier: CHUO-2024-27
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulants and Bleeding Disorders

Keywords

Unfractionated Heparin; Anti-Xa Activity; Catheterization, Central Venous; Blood Specimen Collection; Intensive care

Outcome Measures

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.

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

Secondary Outcomes (2)

• 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

• 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

Other Outcomes (15)

• Types and durations of organ support therapies

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

• Thromboembolic and bleeding complications

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

• Types of blood products transfused

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

Study Arms (4)

Sequence A, B, A, B

EXPERIMENTAL

First and third samples with syringe flush; second and fourth with vacuum tube flush

Procedure: catheter flushing techniques

Sequence A, B, B, A

EXPERIMENTAL

First and fourth samples with syringe flush; second and third with vacuum tube flush

Procedure: catheter flushing techniques

Sequence B, A, B, A

EXPERIMENTAL

Second and fourth samples with syringe flush; first and third with vacuum tube flush

Procedure: catheter flushing techniques

Sequence B, A, A, B

EXPERIMENTAL

Second and third samples with syringe flush; first and fourth with vacuum tube flush

Procedure: catheter flushing techniques

Interventions

catheter flushing techniques PROCEDURE

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).

Sequence A, B, A, B; Sequence A, B, B, A; Sequence B, A, A, B; Sequence B, A, B, A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Person (or support person/relative if unable to do so) who has agreed to participate in the study
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Chu Orleans

Orléans, 45067, France

RECRUITING

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Gregoire MULLER, Dr

  CHU Orléans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregoire MULLER, Dr

CONTACT

+33238229534; gregoire.muller@chu-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 19, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

FR (1)