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Virus-inactivated plasma - Plasmasafe: a one-year experience
Giustina De Silvestro1, Paola Bagatella, Tiziana Tison
1U.O. Immunotrasfusionale, Azienda Ospedaliera Università di Padova.
Blood Transfusion = Trasfusione Del Sangue
|February 11, 2009
Summary
Solvent-detergent inactivated plasma (PlasmaSafe) effectively corrects coagulation defects and treats thrombotic thrombocytopenic purpura (TTP). This study found no adverse reactions in over 8,000 transfusions, highlighting its safety and efficacy.
Area of Science:
- Transfusion Medicine
- Blood Product Safety
- Viral Inactivation
Background:
- Fresh-frozen plasma (FFP) is a standard transfusion product.
- Viral inactivation methods like solvent-detergent (SD) can enhance FFP safety.
- SD-inactivated plasma (PlasmaSafe) was introduced to improve transfusion safety.
Purpose of the Study:
- Evaluate the appropriate use and therapeutic efficacy of PlasmaSafe.
- Assess the quality control of FFP units.
- Monitor clinical effectiveness and adverse reactions of PlasmaSafe.
Main Methods:
- Quality control of 312 FFP units (PT, aPTT, fibrinogen).
- Clinical effectiveness evaluation in 490 patients (879 transfusions).
- Coagulation monitoring in 15 patients and treatment of 3 TTP patients.
Main Results:
- FFP coagulation indicators showed significant variability.
- 76% of patients responded to PlasmaSafe; 2/15 showed no protein S increase.
- TTP patients responded to plasma exchange; 8,422 PlasmaSafe units transfused with no adverse reactions.
Conclusions:
- PlasmaSafe demonstrates standardized coagulation factor content.
- It is effective in correcting coagulation defects and treating TTP.
- No thrombotic complications or transfusion-related adverse reactions were observed.
