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Measurement of Factor V Activity in Human Plasma Using a Microplate Coagulation Assay
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Interindividual Variability and Normal Ranges of Whole Blood and Plasma Thrombin Generation.

Saartje Bloemen1,2, Dana Huskens1,2, Joke Konings1,2

  • 1Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, the Netherlands.

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This study establishes normal ranges for thrombin generation (TG) in plasma and whole blood (WB), finding correlations between TG measurements and key factors. These findings support the clinical use of whole blood TG assays.

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Area of Science:

  • Hemostasis and Thrombosis Research
  • Clinical Coagulation Assays

Background:

  • Thrombin generation (TG) assays are vital in thrombosis and hemostasis research.
  • Adaptation for whole blood (WB) measurement exists, but clinical use is limited by a lack of normal ranges.
  • This study addresses the need for established normal ranges and understanding variability.

Purpose of the Study:

  • To determine normal ranges for TG in platelet-poor plasma (PPP), platelet-rich plasma (PRP), and WB.
  • To assess interindividual variability of TG in different blood matrices.
  • To correlate TG results with coagulation factors, sex, and oral contraceptive (OC) use.

Main Methods:

  • Evaluated study protocol with local medical ethics board.
  • Recruited 129 healthy volunteers who provided informed consent.
  • Determined normal ranges for TG in PPP, PRP, and WB following CLSI guidelines.

Main Results:

  • First study to establish normal TG ranges in PPP, PRP, and WB in a large healthy cohort.
  • Significant correlations observed between plasma and WB TG measurements.
  • Oral contraceptive use was associated with increased TG; thrombomodulin's inhibitory effect varied by sex and OC use.

Conclusions:

  • Establishing normal ranges for TG is a critical step toward clinical application.
  • High correlation between plasma and WB TG suggests WB assays are reliable for clinical settings.
  • Findings support the potential for widespread clinical adoption of whole blood thrombin generation testing.