Comparison of the Best Method for Measuring Anti-Xa Activity in Children Receiving Unfractionated Heparin in Cardiac Intensive Care (COMPAXE-HNF)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood sampling for measuring anti-Xa activity, measurement of anti-XA activity.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease, Unfractionated Heparin, Anti Xa Activity. Basic parameters: 1 Day — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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).
Interventions
- Procedure blood sampling for measuring anti-Xa activity
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 - Procedure measurement of anti-XA activity
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
Primary outcome measures
- 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). [Time frame: "From enrollment to the end of study at 72hours"]
Secondary outcome measures (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). [Time frame: "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) [Time frame: From enrollment to the end of study at 72 hours]
Eligibility criteria
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
- Newborns < 37 weeks gestation
- Patients treated by a humanitarian organization
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07365670 · 2025/RUN/0031 · Ethics Committee