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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-17
SponsorCentre Hospitalier Universitaire de la Réunion

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Newborns < 37 weeks gestation

Patients treated by a humanitarian organization

Trial design

Design model

Single group

Treatments tested in this trial

  • blood sampling for measuring anti-Xa activity

    Procedure/Surgery

    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.

  • measurement of anti-XA activity

    Procedure/Surgery

    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

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: anti-Xa activity monitoringExperimental treatment 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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).

Activated partial thromboplastin time (APTT): Mainly used in the United States and in some French intensive care units, the APTT provides an overall assessment of the activity of several coagulation factors: factor I (or fibrinogen), factor II (or prothrombin), factor V, factor VIII, factor IX, factor X, factor XI, and factor XII. (Figure 1) The APTT is a measure of blood clotting time. It is expressed as a ratio between the patient's APTT and a "control" APTT, which is that of the laboratory. It is expressed in seconds. Normal values for the patient APTT/control APTT ratio are between 0.80 s and 1.20 s. * Above this range: the risk of bleeding increases. * Below this range: treatment is ineffective, with a risk of clot formation.

Time frame
"From enrollment to the end of study at 72 hours"
2

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

The TCA measurement is performed in the same way.

Time frame
From enrollment to the end of study at 72 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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