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 volunteersQualifiers
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
Single group
Treatments tested in this trial
blood sampling for measuring anti-Xa activity
Procedure/SurgeryEach 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/SurgeryEach 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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