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

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.