Activity of Labile Coagulation Factors, Section Factor X and Fibrinogen Level in Frozen Plasma versus Fresh Frozen Plasma

Introduction: Fresh Frozen Plasma (FFP) is a blood component separated from whole blood and frozen below -30°C within 8 hours of donation for optimum preservation of coagulation factors. However, logistic and geographical reasons may hamper separation of plasma within 8 hours and the separation may have to be delayed to between 8 and 24 hours and then frozen below -30°C which is called as Frozen Plasma (FP). Plasma separated between 8 and 24 hours is a licensed blood component in the United States of America (USA) for therapeutic use similar to FFP. It is not licensed in India leading to frequent shortage of plasma.

Aim: To compare the activity of factors V, VIII and X and the level of fibrinogen between FFP and FP, so as to assess the therapeutic use of FP for formulating recommendation as licensed blood component.

Materials and Methods: A prospective observational study was conducted in the Department of Transfusion Medicine at Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India. The duration of the study was 10 months, from January 2018 to October 2018. 50 units each of FFP and FP matched for the camp location, age, gender and blood group were selected. There were 44 males and six females in each of FFP and FP groups. They were compared for the activity of labile coagulation factors (factors V and VIII) and stable factor X. The level of fibrinogen was also measured in both components. It was done within 30 days of preparation of plasma. The mean values of each of the four parameters for FFP and FP were calculated and compared for statistical significance (p) by using unpaired Student’s t-test. Microsoft Excel 2016 was used for statistical analysis. The p-value <0.05 was considered statistically significant.

Results: The mean age of FFP and FP individuals (blood donors) was 31.2 and 31.3 years respectively, while the median age in years was 31 and 30.5, respectively. The activity/level of all the tested coagulation factors was lower in FP as compared to FFP. The difference was statistically significant for factor VIII (p-value <0.05). It was not significant for factor V, X and fibrinogen. The level/activity of coagulation factors in FP, though lower than that in FFP, fell within normal reference range in 90-95% of units.

Conclusion: FP may be used as a therapeutic alternative to FFP excluding patients of haemophilia A in whom factor VIII concentrate and cryoprecipitate are considered better therapeutic modalities. Results of similar multicentre studies will help in formulating recommendations regarding licensing.