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Comparative in vitro investigation of prothrombin complex concentrates
J Römisch1, K Bonik, H G Müller
1Centeon Pharma GmbH, Marburg/Lahn, Germany.
Seminars in Thrombosis and Hemostasis
|May 14, 1998
Summary
Commercial prothrombin complex concentrates (PCCs) show significant in vitro differences in clotting factors and protein content. Despite improved homogeneity, distinct profiles and assay results differentiate these vital hemostatic agents.
Area of Science:
- Biochemistry
- Hematology
- Pharmacology
Background:
- Prothrombin complex concentrates (PCCs) are critical for treating coagulation factor deficiencies.
- Previous comparative studies indicated variability among commercial PCC products.
Purpose of the Study:
- To compare the in vitro activities and contents of three commercial PCC products.
- To identify specific differences in clotting factors, regulatory proteins, and potential contaminants.
Main Methods:
- In vitro analysis of prothrombin complex concentrate (PCC) factors (FII, FVII, FIX, FX).
- Quantification of regulatory proteins (Proteins C, S, Z) and activated factors (FVIIa).
- Assay for residual amidolytic activities and detection of specific ingredients like heparin and antithrombin III.
Main Results:
- Significant variations were observed in the content and activity of specific PCC factors and proteins.
- While global activated factor tests showed minimal differences, FVIIa levels and residual amidolytic activities varied considerably.
- Heparin was present in all tested PCCs at differing concentrations, and antithrombin III was detected in only two of the three products.
Conclusions:
- Commercial PCC products exhibit distinct in vitro profiles despite overall improved homogeneity.
- Specific assays can differentiate PCCs based on their composition, including clotting factors, regulatory proteins, and contaminants.
- These findings highlight the importance of understanding product-specific characteristics for optimal clinical use.