Article Text

PDF
Lyophilised plasma: evaluation of clotting factor activity over 6 days after reconstitution for transfusion
  1. Helge Schoenfeld1,2,
  2. Axel Pruss1,
  3. Mareike Keller2,
  4. Michael Schuster3,
  5. Kristian Meinck3,
  6. Bruno Neuner4,
  7. Christian von Heymann2
  1. 1Institute of Transfusion Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany
  2. 2Department of Anaesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum and Campus Charité Mitte, Berlin, Germany
  3. 3Institute for Medical Diagnostics Oderland, Frankfurt (Oder), Germany
  4. 4Institute of Epidemiology and Social Medicine, Section of Clinical Epidemiology, University of Münster, Münster, Germany
  1. Correspondence to Dr Helge Schoenfeld, Institute of Transfusion Medicine, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany; helge.schoenfeld{at}charite.de

Abstract

Aims Little is known about long-term stability of clotting factors in dissolved human lyophilised plasma. This study evaluated clotting factor and inhibitor activity in reconstituted lyophilised plasma after storage for up to 6 days at 4°C.

Methods Five samples from different lots of pooled lyophilised plasma (LyoPlas; German Red Cross Blood Transfusion Service West) were reconstituted. The activity of fibrinogen, factor II (FII), FV, FVII, FVIII, FIX, FX, FXI, FXII, FXIII, antithrombin, plasmin inhibitor, von Willebrand factor antigen, free protein S and protein C were determined immediately and at 2, 4, 6, 24, 48, 72, 96, 120 and 144 h after reconstitution. Tests for bacterial contamination were performed after 12, 72 and 144 h from each plasma bottle.

Results Storage at 4°C for 6 h led to a decrease in the activity of FVIII (Δ −14.9%), FIX (Δ −6.9%) and FXI (Δ −6.3%), and an increase in the activity of plasmin inhibitor (Δ +10.2%). Storage for up to 6 days resulted in a further decrease in activity of FVIII (Δ −24.3%), FIX (Δ −13.4%) and FXI (Δ −22.9%), and, additionally, a decrease in the activity of FV (Δ −15.0%), fibrinogen (Δ −6.9%) and plasmin inhibitor (Δ −17.5%). Other factors and inhibitors, with exception of protein C (Δ +8.2%), remained almost unchanged over time. Blood cultures were sterile and showed no bacterial growth.

Conclusions The activity of all measured coagulation factors and inhibitors in a time course of up to 6 days met required quality standards. Further in vivo testing is required to demonstrate safety and efficacy of extended clinical use of refrigerated reconstituted lyophilised plasma.

  • Blood coagulation factor inhibitors
  • coagulation factors
  • freeze drying
  • plasma

Statistics from Altmetric.com

Footnotes

  • HS and AP contributed equally as first authors to the conduct of this trial and the drafting of the manuscript.

  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.