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

Starting soon · Not applicable

Conditions studied: Congenital Heart Disease, Unfractionated Heparin, Anti Xa Activity

In brief

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.

Key facts

Study ID

NCT07365670

Run by

Centre Hospitalier Universitaire de la Réunion

People needed

22

Starts

2026-04-01

Expected to finish

2029-04-05

Last updated by the study team

2026-01-26

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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
• 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).

You may not qualify if…

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

Full record on ClinicalTrials.gov

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