Comparison of the Best Method for Measuring Anti-Xa Activity in Children Receiving Unfractionated Heparin in Cardiac Intensive Care (COMPAXE-HNF)

NCT07365670 | Not Yet Recruiting

• 2 other identifiers: 2025/RUN/0031Ethics Committee
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare the accuracy of two different blood sampling methods from a central venous catheter (CVC) for measuring anti-Xa activity in children receiving unfractionated heparin (UFH) from this CVC. The results will be compared to a "gold standard" sample taken from an arterial catheter (KTA) whithout UFH. The objective is to identify a more reliable method for monitoring UFH, thereby reducing the risk of bleeding or thrombosis in these patients.

Conditions

Congenital Heart Disease; Unfractionated Heparin; Anti Xa Activity

Keywords

Unfractionated Heparin; Anti-Xa activity; Pediatric Intensive Care; Congenital Heart Disease; Blood Sampling; Central Venous Catheter; Arterial Catheter; Thrombosis; Hemostasis.

Outcome Measures

Primary Outcomes (1)

• Measurement of anti-Xa activity (in IU/mL) from two samples (with and without HNF pause) taken from the central venous line where HNF is administered, compared to a sample taken from a non-heparinized arterial catheter (i.e., gold standard).

  Anti-Xa activity and APTT measurements will be performed at the university hospital's central laboratory, which guarantees the consistency of the reagents, automated systems, and techniques used. The recommended therapeutic target is between 0.3 and 0.6 IU/mL.

  "From enrollment to the end of study at 72hours"

Secondary Outcomes (2)

• Measurement of APTT from two samples (with and without HNF pause) taken from the central venous line where HNF is administered, compared to a sample taken from a non-heparinized arterial catheter (i.e., gold standard).

  "From enrollment to the end of study at 72 hours"

• Measurement of APTT and anti-Xa activity (in IU/mL) from a sample taken from a non-heparinized arterial catheter (i.e., gold standard)

  From enrollment to the end of study at 72 hours

Study Arms (1)

anti-Xa activity monitoring

EXPERIMENTAL

All patients included in the study

Procedure: blood sampling for measuring anti-Xa activity; Procedure: measurement of anti-XA activity

Interventions

blood sampling for measuring anti-Xa activity PROCEDURE

Each patient included in the study will have a series of three samples taken every 4 hours for 3 days: * Sample taken from a non-heparinized arterial catheter (Gold Standard), performed as part of routine care: Method ① * Sample taken from a central venous catheter without stopping the HNF: Method ② * Sampling from a central venous catheter with an HNF pause: Method ③ At each anti-Xa activity check in the included patients, the nurse will take the 3 blood samples. The order in which samples ② and ③ are taken will be determined by randomization.

anti-Xa activity monitoring

measurement of anti-XA activity PROCEDURE

Each patient will have, each time that anti-Xa activity needs to be measured, three successive samples taken: * Sample taken from a non-heparinized arterial catheter (gold standard), performed as part of routine care: Method ① * Sample taken from a central venous catheter without stopping the HNF: Method ② * Sample from central venous catheter with HNF pause: Method ③

anti-Xa activity monitoring

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Minors aged 0 to 17 inclusive
• Weight greater than or equal to 3.5 kg
• Admitted to resuscitation or congenital cardiac intensive care
• Requiring treatment with unfractionated heparin at curative doses administered via central venous access
• Equipped with a central arterial and venous catheter
• Affiliated with or beneficiary of a social security scheme

You may not qualify if:

• Newborns \< 37 weeks gestation
• Patients treated by a humanitarian organization

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

MeSH Terms

Conditions

Heart Defects, Congenital; Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Marie CONEAU

CONTACT

+262693829524; marieconeau@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an interventional, prospective, single-center (pediatric congenital cardiac intensive care unit at the Réunion University Hospital, North site) study of diagnostic performance. * Comparison procedure: sampling from a non-heparinized arterial catheter (gold standard), performed as part of routine care: Method ① * Experimental procedure, performed as part of the research: two samples taken from a central venous catheter (CVC) * Sample taken from central venous catheter without HNF pause: Method ② * Sample taken from central venous catheter with HNF pause: Method ③ At each anti-Xa activity check in the patients included, the IDE will take the 3 blood samples. The order in which samples ② and ③ are taken will be determined by randomization. The laboratory will be blinded to the sampling method in order to guarantee the objectivity of the results.

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 26, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 5, 2029
• Study Completion (Estimated): April 5, 2029
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share