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An Ethanol-Free Autologous Thrombin System.

Andrea M Matuska1, Marina K Klimovich1, John R Chapman1

  • 1Arthrex, Inc., Naples, Florida; and.

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|December 25, 2018
PubMed
Summary

A novel point-of-care device prepares ethanol-free autologous serum (AS) with significant thrombin activity. This system offers a safer, reliable alternative for hemostasis and wound healing applications.

Keywords:
autologousblood-coagulationdevicefibrinplatelet rich plasmathrombin

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Area of Science:

  • Biochemistry
  • Biomedical Engineering
  • Regenerative Medicine

Background:

  • Thrombin is crucial for hemostasis and wound healing.
  • Autologous thrombin avoids pathogen transmission and immune responses.
  • Existing methods use ethanol, posing cytotoxicity risks.

Purpose of the Study:

  • To evaluate a new point-of-care device for preparing ethanol-free autologous serum (AS).
  • To assess the reliability and flexibility of the Thrombinator™ System.
  • To determine the thrombin activity and bone graft scaffold formation capabilities.

Main Methods:

  • The Thrombinator™ System was used to prepare AS from whole blood (WB) and platelet-poor plasma (PPP).
  • 120 devices were tested across 30 healthy donors.
  • Thrombin activity was measured using a coagulation analyzer; scaffold cohesion was assessed with a durometer.

Main Results:

  • Average thrombin activity was 20.6 ± 2.7 IU/mL from WB and 13.4 ± 3.8 IU/mL from PPP.
  • Clot times were 3.9 seconds (WB) and 5.9 seconds (PPP).
  • The system demonstrated reliability, flexibility with varying blood volumes, and consistent production over four cycles.

Conclusions:

  • The Thrombinator™ System reliably produces ethanol-free autologous serum with significant thrombin activity.
  • This method offers a safer alternative to ethanol-based preparations for hemostasis and regenerative medicine.
  • Cohesive bone graft scaffolds were consistently formed when AS was combined with other materials.