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Published on: January 29, 2014
Paired comparison of methylene blue- and amotosalen-treated plasma and cryoprecipitate
L Backholer1, M Wiltshire1, S Proffitt1
1NHS Blood and Transplant, Cambridge, UK.
Background And Objectives:
Cryoprecipitate is used in the treatment of patients with acquired hypofibrinogenaemia. Studies have not directly compared cryoprecipitate produced following pathogen inactivation (PI) of fresh-frozen plasma (FFP) using different systems. The effects of methylene blue (MB) and amotosalen (AS) PI systems on the quality of FFP and cryoprecipitate were investigated in a paired study.
Materials And Methods:
Seven group A and 7 group O pools of plasma were prepared and split into individual units and rapidly frozen to produce FFP. Units of FFP were thawed and either PI treated with MB or amotosalen, or left untreated (control). Samples of FFP along with the corresponding cryoprecipitate were tested for a range of coagulation factors, thrombin generation (TGT) and rotational thromboelastometry (ROTEM).
Results:
AS-FFP showed a smaller decrease following treatment for most coagulation factors analysed than MB-FFP, except fibrinogen (antigen) and factor VII, partly due to lower volume losses. There was no significant difference between treatment methods for fibrinogen content of cryoprecipitate with treated units meeting current UK specification, or TGT and ROTEM parameters studied.
Conclusions:
MB-cryo contained a significantly higher content of FVIII and lower content of FXIII when compared to AS-cryo, with no difference in fibrinogen activity.
Insights
Pathogen inactivation (PI) of fresh-frozen plasma (FFP) using methylene blue (MB) or amotosalen (AS) systems impacts cryoprecipitate quality. While both methods yield acceptable fibrinogen, MB-PI cryoprecipitate shows higher FVIII and lower FXIII content than AS-PI cryoprecipitate.
Area of Science:
- Blood product safety
- Plasma processing
- Coagulation science
Background:
- Cryoprecipitate is crucial for treating acquired hypofibrinogenemia.
- No direct comparisons exist for cryoprecipitate quality after different pathogen inactivation (PI) systems on fresh-frozen plasma (FFP).
- Investigating the impact of methylene blue (MB) and amotosalen (AS) PI systems on FFP and cryoprecipitate quality is essential.
Purpose of the Study:
- To compare the effects of methylene blue (MB) and amotosalen (AS) pathogen inactivation (PI) systems on the quality of fresh-frozen plasma (FFP) and its derived cryoprecipitate.
- To evaluate coagulation factor content, thrombin generation (TGT), and rotational thromboelastometry (ROTEM) parameters.
Main Methods:
- Paired study design using pooled group A and O plasma.
- FFP units were treated with MB or amotosalen PI systems, or left untreated (control).
- Analysis included coagulation factors, TGT, and ROTEM of FFP and corresponding cryoprecipitate.
Main Results:
- Amotosalen-treated FFP (AS-FFP) had smaller decreases in most coagulation factors compared to methylene blue-treated FFP (MB-FFP), except for fibrinogen and factor VII, due to lower volume loss.
- No significant differences were observed in cryoprecipitate fibrinogen content between MB and AS treatments, with both meeting UK specifications.
- Thrombin generation and ROTEM parameters showed no significant differences between treatment groups.
Conclusions:
- Methylene blue-treated cryoprecipitate (MB-cryo) exhibited significantly higher Factor VIII (FVIII) content compared to amotosalen-treated cryoprecipitate (AS-cryo).
- Methylene blue-treated cryoprecipitate (MB-cryo) showed significantly lower Factor XIII (FXIII) content than amotosalen-treated cryoprecipitate (AS-cryo).
- Fibrinogen activity in cryoprecipitate was not significantly different between the MB and AS pathogen inactivation methods.

