Assessment of the quality of fresh frozen plasma and refrozen thawed fresh frozen plasma – A prospective study at a tertiary care teaching hospital in Chennai
Authors :
D. Umesh, Arumugam P
DOI : 10.18231/2394-6792.2018.0053
Volume : 5
Issue : 2
Year : 0
Page No : 286-289
Introduction: FFP contains the labile as well as stable components of the coagulation, fibrinolytic and complement systems. The use of plasma and its products has increased manifold over the four decades. In blood transfusion service, the primary goal of quality is 'transfusion of safe unit of blood.'
Aim of the Study: To ensure that the prepared fresh frozen plasma (FFP) consistently met the requirements for quality and to find out the potency and possible extension of shelf life of fresh frozen plasma once thawed and refrozen within stipulated period.
Materials and Methods: 66 units of FFP prepared by Platelet Rich Plasma (PRP) method were divided into two groups. Group 1 comprised of 33 samples, which were tested on 0 day, last week of 12th month and last week of 18th month. Group 2 comprised of remaining 33 units which were tested on 0 day, thawed and tested on 1st week of 12th month and were again refrozen within 12 hours of thawing. Later, the refrozen units were again retested on the last week of 12th month. All the FFP units were evaluated as per the DGHS Guidelines.
Results: Group 1: The quality of fresh frozen plasma stored at -30OC for 12 months adhered to quality parameters but on extended storage period (-30OC for 18 months) showed non-compliance to the standardized quality control. Group 2: Refrozen thawed plasma complied with all quality parameters.
Discussion: Fibrinogen and Factor VIII levels, which were representative of stable and labile factors respectively, were within normal limits in both the study groups when stored at standardized temperature and time, but showed non-compliance to the standardized quality control at extended time. Refrozen thawed plasma retained all coagulation factors. These findings were in concordance with the DGHS Standards and various other studies.
Conclusion: Fresh Frozen Plasma should be used judiciously and if thawed plasma is not used for some reasons, it should not be discarded. The thawed FFP can be refrozen and added up to the inventory and hence, useful to the society.
Keywords: Good manufacturing practice, Fresh frozen plasma, Platelet rich plasma, Thawed and refrozen fresh frozen plasma.
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