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

Browse trials for

• Heart Defects, Congenital 1,003
• Thrombosis 1,507

Keywords

• Unfractionated Heparin
• Anti-Xa activity
• Pediatric Intensive Care
• Congenital Heart Disease
• Blood Sampling
• Central Venous Catheter
• Arterial Catheter
• Thrombosis
• Hemostasis.

Study arms

• Experimental
  anti-Xa activity monitoring

  All patients included in the study

  Procedure: blood sampling for measuring anti-Xa activity · Procedure: measurement of anti-XA activity

Interventions

• Procedureblood 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 and ③ are taken will be determined by randomization.

• Proceduremeasurement 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 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

Individual participant data

Plan to share: No