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Reference Intervals for Coagulation Parameters in Developmental Hemostasis from Infancy to Adolescence

Giovina Di Felice1, Matteo Vidali2, Gelsomina Parisi1

  • 1Clinical Laboratory Unit, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.

Diagnostics (Basel, Switzerland)
|October 27, 2022
PubMed

Insights

Establishing age and sex-specific reference intervals for pediatric coagulation tests is crucial. This study provides these vital reference ranges for children aged 0-16 years to prevent misdiagnosis and improve patient care.

Area of Science:

  • Pediatric Hematology
  • Clinical Coagulation
  • Laboratory Medicine

Background:

  • Pediatric coagulation assays require distinct reference intervals compared to adults.
  • Current reference ranges may not accurately reflect the physiological differences in children.
  • Accurate reference intervals are essential for diagnosing and managing bleeding and thrombotic disorders in pediatric populations.

Purpose of the Study:

  • To establish age- and sex-dependent reference intervals for a comprehensive panel of coagulation assays in healthy children.
  • To cover a wide pediatric age range from neonates (0 days) to adolescents (16 years).
  • To provide data supporting the use of pediatric-specific reference ranges in clinical practice.

Main Methods:

  • Coagulation assays including PT, aPTT, Fibrinogen, Antithrombin, Protein C, Protein S, Thrombin time, D-Dimer, vWF antigen, Lupus anticoagulant, pathway factors, and APC resistance were performed.
  • The STA-R Max2 analyzer was utilized for all tested coagulation parameters.
  • The Harrell-Davis bootstrap method was employed to establish 95% reference intervals, with 90% confidence intervals calculated using the bootstrap percentile method.

Main Results:

  • Data were collected from 1280 healthy children (671 males, 609 females) across five age groups: 0-15 days, 15-30 days, 1-6 months, 6-12 months, and 1-16 years.
  • Age and sex-specific 95% reference intervals were successfully determined for all evaluated coagulation assays.
  • Significant variations in coagulation parameters were observed across different pediatric age strata.

Conclusions:

  • The study confirms the necessity of distinct reference intervals for pediatric coagulation testing.
  • Utilizing adult reference intervals for children can lead to misdiagnosis of coagulation disorders.
  • Implementing age- and sex-specific reference ranges is critical for accurate diagnosis, appropriate treatment, and improved patient outcomes in pediatrics.

Keywords:
coagulationpediatricsreference interval

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