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Self-monitoring of oral anticoagulation therapy in children

Paolo Paioni1, Sabine Kroiss, Elsbeth Kägi

  • 1Divisions of Paediatrics, University Children's Hospital, Zurich, Switzerland.

Acta Haematologica
|October 10, 2009
PubMed

Insights

Home International Normalized Ratio (INR) self-monitoring is accurate for pediatric patients on long-term anticoagulation therapy. The CoaguChek XS device demonstrated higher accuracy than the CoaguChek S for monitoring blood clotting in children.

Area of Science:

  • Pediatric Hematology
  • Clinical Pathology
  • Medical Device Technology

Background:

  • Long-term oral anticoagulation therapy is crucial for pediatric patients with various medical conditions.
  • Accurate monitoring of anticoagulation, typically via International Normalized Ratio (INR), is essential for patient safety and treatment efficacy.
  • Home self-monitoring offers a convenient alternative to frequent laboratory testing, but its accuracy in children needs validation.

Purpose of the Study:

  • To assess the accuracy and clinical agreement of home International Normalized Ratio (INR) self-monitoring in pediatric patients.
  • To compare the performance of two portable prothrombin time monitors (CoaguChek S and XS) using capillary blood against laboratory analysis of venous blood.
  • To evaluate the reliability of self-monitoring for children on long-term oral anticoagulation therapy.

Main Methods:

  • A prospective study involving 35 pediatric patients (4 months to 18 years) on long-term oral anticoagulation.
  • Comparison of INR values obtained from capillary whole blood using CoaguChek S (n=56) and CoaguChek XS (n=27) devices with venous blood INR values analyzed by a laboratory coagulation analyzer.
  • Statistical analysis using Bland-Altman analysis to evaluate agreement and Pearson correlation coefficients to assess reliability.

Main Results:

  • High overall agreement between venous and capillary INR measurements (mean difference -0.04, limits of agreement -0.63 to 0.55).
  • The CoaguChek XS showed superior accuracy (mean difference -0.13) compared to the CoaguChek S (mean difference 0.006).
  • High Pearson correlation coefficients (0.88 overall, 0.84 for CoaguChek S, 0.95 for CoaguChek XS) and excellent agreement rates (97.6% expanded, 94% narrow).

Conclusions:

  • Home INR self-monitoring is a reliable and accurate method for pediatric patients requiring long-term oral anticoagulation.
  • The CoaguChek XS portable monitor demonstrates greater accuracy in self-monitoring INR for children compared to the CoaguChek S.
  • These findings support the use of home INR self-monitoring devices, particularly the CoaguChek XS, to improve anticoagulation management in pediatric populations.

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