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

Centre Hospitalier Universitaire de la Réunion

Status

Begins enrollment in 1 month

Conditions

Anti Xa Activity

Unfractionated Heparin

Congenital Heart Disease

Treatments

Procedure: blood sampling for measuring anti-Xa activity

Procedure: measurement of anti-XA activity

Study type

Interventional

Funder types

Other

Identifiers

NCT07365670

Ethics Committee (Other Identifier)

2025/RUN/0031

Details and patient eligibility

About

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.

Full description

Scientific Justification: UFH is widely used in pediatric cardiac intensive care for its short half-life and availability of an antidote. However, monitoring its effect via anti-Xa activity is challenging. The standard method of sampling from a CVC is known to be prone to heparin contamination, leading to inaccurate results (over- or under-anticoagulation). This lack of precision can lead to dangerous complications like major bleeding or thrombotic events. As studies by Palermo et al. (1980) and Bauman et al. (2012) have shown, the unreliability of CVC samples justifies the search for a safer alternative. The arterial catheter (KTA) provides a contamination-free "gold standard," making it the ideal comparison for evaluating the more reliable sampling method.
Procedure: The study will compare two CVC sampling methods (a standard flush protocol and a new experimental method) against the gold standard (KTA sampling without UFH)
Follow-up: The study will be conducted over three consecutive days. Each day, three sets of blood samples will be collected every 6 hours per patient (KTA, standard CVC, and experimental CVC).

Enrollment

22 estimated patients

Sex

All

Ages

1 day to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
Free, informed, and written consent signed by one of the two representatives of parental authority and the investigator (no later than the day of inclusion and before any examination required by the research).

Exclusion criteria