Stability of human thrombin produced from 11 ml of plasma using the thrombin processing device

Area of Science:

• Biochemistry
• Biotechnology
• Surgical Hemostasis

Background:

• Autologous thrombin, derived from patient plasma, is valuable for surgical hemostasis.
• Traditional methods of thrombin generation result in rapid degradation, limiting clinical utility.
• The Thrombin Processing Device (TPD) was developed to improve the stability and practicality of autologous thrombin production.

Purpose of the Study:

• To evaluate the stability of autologous thrombin generated by the Thrombin Processing Device (TPD).
• To determine the optimal production and storage temperatures for maximizing thrombin activity and shelf-life.
• To assess the feasibility of using TPD-generated thrombin for intraoperative hemostasis.

Main Methods:

• Autologous thrombin was produced using the TPD by activating plasma with calcium chloride and ethanol.
• Thrombin was generated at three different temperatures: 18°C, 24°C, and 27°C.
• The produced thrombin was stored at its production temperature, 4°C, or 35°C for up to 6 hours.
• Thrombin activity was quantified by measuring the time to clot formation using fibrinogen concentrate.

Main Results:

• Thrombin produced at 18°C showed limited stability, degrading significantly within 4 hours, especially when stored at 35°C.
• Thrombin produced at 24°C and 27°C demonstrated remarkable stability, maintaining rapid clotting times for up to 6 hours at both 4°C and 35°C storage temperatures.
• Optimal stability was achieved when thrombin was produced at 24°C or 27°C and subsequently stored at 4°C.

Conclusions:

• The stability of autologous thrombin generated by the TPD is significantly influenced by both production and storage temperatures.
• The TPD can reliably produce active autologous human thrombin with a clinically relevant stability of up to 6 hours.
• Specific production (24°C or 27°C) and storage (4°C) parameters are recommended for maximizing the efficacy of TPD-generated thrombin in surgical settings.