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Related Experiment Videos

[Thrombogenicity of prothrombin complex concentrates].

G Dornheim1, H P Klöcking, R Wulkow

  • 1Bezirksinstitut für Spende- und Transfusionswesen Suhl.

Folia Haematologica (Leipzig, Germany : 1928)
|January 1, 1990
PubMed
Summary

Two methods for isolating prothrombin complex concentrates (PCCs) were compared. DEAE-Sephadex A-50 yielded a more thrombogenic PCC than Molselect DEAE-50, indicating differences in product quality.

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Area of Science:

  • Biochemistry
  • Hematology
  • Pharmacology

Background:

  • Prothrombin complex concentrates (PCCs) are crucial for treating coagulation factor deficiencies.
  • The isolation method can influence the properties and thrombogenicity of PCCs.
  • Understanding these differences is vital for ensuring product safety and efficacy.

Purpose of the Study:

  • To compare the thrombogenicity of PCCs isolated using two different ion-exchange resins: DEAE-Sephadex A-50 and Molselect DEAE-50.
  • To evaluate the impact of particle size and source of the ion-exchange resin on PCC thrombogenicity.

Main Methods:

  • PCCs were isolated from human plasma using DEAE-Sephadex A-50 (40-120 microns) or Molselect DEAE-50 (100-320 microns) after cryoprecipitation of factor VIII.
  • In vitro assays (NAPTT, TGt50) and an in vivo rat model (Wessler's venous stasis) were used to assess thrombogenicity.

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  • Effective dose 50 (ED50) values for thrombus formation were determined.

    • Main Results:

    • PCC isolated with DEAE-Sephadex A-50 exhibited significantly higher thrombogenicity compared to PCC isolated with Molselect DEAE-50.
    • The ED50 for thrombus formation was 15 Factor IX U/kg for the DEAE-Sephadex A-50 product and 210 Factor IX U/kg for the Molselect DEAE-50 product.
    • These findings highlight a substantial difference in thrombogenic potential based on the isolation resin.

    Conclusions:

    • The choice of ion-exchange resin significantly impacts the thrombogenicity of isolated PCCs.
    • DEAE-Sephadex A-50 results in a more thrombogenic PCC than Molselect DEAE-50.
    • This study underscores the importance of considering resin properties in the manufacturing of PCCs to optimize safety and therapeutic outcomes.