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| ID | Type | Description | Link |
|---|---|---|---|
| Ethics Committee | Other Identifier | CPP Sud Méditerranée I |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-Xa activity monitoring | Experimental | All patients included in the study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sampling for measuring anti-Xa activity | Procedure | Each patient included in the study will have a series of three samples taken every 4 hours for 3 days:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | "From enrollment to the end of study at 72hours" |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie CONEAU | Contact | +262693829524 | marieconeau@gmail.com |
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This is an interventional, prospective, single-center (pediatric congenital cardiac intensive care unit at the Réunion University Hospital, North site) study of diagnostic performance.
Comparison procedure: sampling from a non-heparinized arterial catheter (gold standard), performed as part of routine care: Method ①
Experimental procedure, performed as part of the research: two samples taken from a central venous catheter (CVC)
At each anti-Xa activity check in the patients included, the IDE will take the 3 blood samples.
The order in which samples ② and ③ are taken will be determined by randomization.
The laboratory will be blinded to the sampling method in order to guarantee the objectivity of the results.
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| measurement of anti-XA activity | Procedure | Each patient will have, each time that anti-Xa activity needs to be measured, three successive samples taken:
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| "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) | The TCA measurement is performed in the same way. | From enrollment to the end of study at 72 hours |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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