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

Sponsor
Centre Hospitalier Universitaire de la Réunion
Study ID
NCT07365670
Status
Not Yet Recruiting

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Conditions

  • Anti Xa Activity
  • Congenital Heart Disease
  • Unfractionated Heparin

Eligibility Criteria

Sex
ALL
Age
1 Day - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 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: * 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
    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

Study Details

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.

Key Dates

First listed
Jan 26, 2026
Start date
Apr 1, 2026
Status verified
Jan 2026
Primary completion
Apr 5, 2029
Completion
Apr 5, 2029

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: anti-Xa activity monitoring
    All patients included in the study

Primary Outcome Measure

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" ]

Central Contacts

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