Abstract

Introduction: Fresh Frozen Plasma (FFP) is mainly indicated for patients with active bleeding or for those preparing to undergo surgical procedures. However, the product should only be considered when factor concentrates are not available or when the benefit-to-risk ratio is maximum.  This study aimed to assess whether the FFP meets the quality standards in regards to antihemophilic factor (FVIII) activity and fibrinogen level, with the acceptance limits of not less than 0.70 IU/ml for FVIII, and normal level for fibrinogen.

Methods: This cross-sectional study was conducted at the National Blood Transfusion and Research Center, Aden, Yemen from August to September 2022. A total of 206 FFP units were selected using stratified random sampling method, with 103 samples from O and 103 from non-O blood groups. FVIII and fibrinogen levels were measured in each sample at two points: baseline and post-thaw. The measurements were carried out using STart Max coagulation analyzer and reagents purchased from Diagnostica Stago. Statistical analysis was performed using SPSS version 26, with a significance level set at P<0. 05.

Results: From baseline to post-thaw, a statistically significant reductions were observed in the average FVIII (20%) and fibrinogen (4.9%) levels. Of all tested FFP, 75.2% units had FVIII levels of ≥0.70 IU/ml.

Conclusion: The majority of FFP units met the international quality standards in regards to FVIII and fibrinogen levels, and were suitable for clinical use.

Keywords: Fresh Frozen Plasma, Factor VIII, Fibrinogen, Quality Assessment.

• PDF