Developmental haemostasis. Impact for clinical haemostasis laboratories

Area of Science:

• Pediatric Hematology
• Clinical Coagulation
• Laboratory Medicine

Background:

• Developmental haemostasis, established in the 1980s, describes age-related changes in blood coagulation.
• Significant advancements in coagulation analyzers and reagents have occurred since the initial establishment of these ranges.
• Coagulation testing is known to be sensitive to variations in analytical systems and reagents.

Purpose of the Study:

• To investigate if modern coagulation testing systems (STA Compact analyser, Diagnostica Stago reagents) show age-related sensitivity in coagulation assays.
• To determine if the reference ranges for developmental haemostasis established by Andrew et al. remain appropriate for current laboratory practices.
• To establish new age-associated reference ranges for specific coagulation factors and assays in neonates and children.

Main Methods:

• A large-scale study was conducted to analyze coagulation parameters in neonates and children.
• The study utilized a current-day coagulation testing system, including the STA Compact analyser and Diagnostica Stago reagent system.
• Age-specific reference ranges were determined for various coagulation assays, including D-dimers, TFPI, and endogenous thrombin potential.

Main Results:

• The study confirmed the fundamental principles of developmental haemostasis.
• Absolute values for coagulation assay reference ranges in neonates and children were found to vary significantly depending on the analyzer and reagent system used.
• New age-related reference ranges for D-dimers, TFPI, and endogenous thrombin potential were established.

Conclusions:

• Coagulation laboratories must develop and implement age-specific reference ranges tailored to their unique testing systems.
• Accurate diagnosis and management of bleeding or clotting disorders in pediatric populations depend on system-specific reference ranges.
• The findings underscore the need for updated reference ranges to reflect current analytical technologies in pediatric coagulation testing.