Assessment and association of coagulation factors (FVIII and fibrinogen) with the mode of collection and storage of fresh frozen plasma

Autor: Rajendran Loganathan, Rajendra G Kulkarni, Rakhee Kar, B Abhishekh, Debdatta Basu
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: Global Journal of Transfusion Medicine, Vol 4, Iss 2, Pp 204-207 (2019)
Druh dokumentu: article
ISSN: 2468-8398
2455-8893
DOI: 10.4103/GJTM.GJTM_41_19
Popis: Background: Indian Drugs and Cosmetics Act and Rules 1945 states that 1% or 4 units/month of any components prepared and stored should meet specific quality control parameter. Currently, our blood center relies on nonancillary tests such as prothrombin time (PT)/activated PT test for quality check of fresh frozen plasma (FFP). However, the guidelines advice to check the levels of labile coagulation factors, routinely. Aim: This study was conducted to establish coagulation factor assay and assess conditions such as collection, transportation, time of preparation, and storage conditions to assess the level of clotting factors FVIII and fibrinogen in FFP and to identify the association of the levels of clotting factors FVIII and fibrinogen in FFP with its mode of collection and storage. Materials and Methods: A cross-sectional study was carried out delimiting inclusion criteria as the FFP to be prepared from whole blood collected in-house or at outdoor blood collection drives blood with varying duration of storage within 12 months; the exclusion criteria on units that were discarded reasons due to leaking in bags found positive for transfusion transmitted infections. The sample size was calculated based on logistics, budget, and convenient sampling technique. Statistical analysis was carried out using software IBM PASW statistics (SPSS) version 19.0, and independent Student's one-way analysis of variance for levels of statistical significance was considered at P < 0.05 among the parameters such as clotting factors among the different blood groups. Results: There was no significant difference observed on different modes of collection between the levels of FVIII and fibrinogen. However, the difference between FVIII levels with different time-lapse of component processing was statistically significant (P = 0.002). However, regarding fibrinogen such a difference was not a significant difference. Conclusion: Heat-labile factors were maintained as per the DGHS criteria when FFP was prepared within 4 h and stored for 6 months.
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