Skip to main content

Advertisement

SpringerLink
Log in

Universal fresh frozen plasma (Uniplas): a safe product in open-heart surgery

  • Original
  • Published:
Intensive Care Medicine Aims and scope Submit manuscript

Abstract

Objective

To test the tolerability and safety of the universal plasma Uniplas [solvent/detergent (SD)-treated plasma], infused regardless of the patient's blood group.

Design

Prospective, parallel group, controlled and observer-blinded study, randomized with respect to patients requiring plasma transfusion.

Setting

Cardiothoracic operating room and ICU in a university hospital.

Patients

Eighty-four patients undergoing open-heart surgery comparing three parallel treatment groups and one control group.

Interventions

The Uniplas treatment group was subdivided into patients with blood group A, B or AB, and group O. The treatment group receiving Octaplas of type AB, was not subdivided. Patients who did not require any plasma transfusion served as control.

Measurements

Complement activation (C3bc, TCC), direct antiglobulin test (DAT) and other immunohaematological tests, tests for haemolysis, and relevant clinical observations during treatment phase. Blood samples were collected again after 6 months for evaluation of viral safety.

Results

Of the 84 patients, 29 served as control group. Uniplas was transfused in 36 of the patients (1–23 units). Octaplas was transfused in 19 patients (1–11 units). During the study no clinical adverse events related to plasma transfusion were observed. The degree of complement activation C3bc and TCC, a recommended test for biocompatibility, did not show any increased activation after Uniplas or Octaplas transfusion. No haemolytic reactions, positive DAT-tests or viral transmissions were observed after Uniplas transfusion.

Conclusion

In open-heart surgery, Uniplas, which can be transfused regardless of a patient's blood group, was well-tolerated and gave no adverse drug reactions.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1.
Fig. 2.

Similar content being viewed by others

References

  1. Solheim BG, Svennevig JL, Mohr B, Dragsund M, Noddeland H, Tølløfsrud S (1993) The use of Octaplas in patients undergoing open-heart surgery. In: Muller-Berghaus G, et al (eds) DIC: Pathogenesis, diagnosis and therapy of disseminated intravascular fibrin formation. Elsevier Science, pp 253–262

  2. Horowitz B, Bonoma R, Prince AM, Chin SN, Brotman B, Schulman RW (1992) Solvent/detergent treated plasma: a virus-inactivated substitue for fresh frozen plasma. Blood 79:826–831

    CAS  PubMed  Google Scholar 

  3. Hellstern P, Sachse H, Schwinn H, Oberfrank K (1992) Manufacture and in vitro characterization of solvent/detergent-treated human plasma. Vox Sang 63:178–185

    CAS  PubMed  Google Scholar 

  4. Beeck H, Hellstern P (1998) In vitro characterization of solvent/detergent-treated human plasma and of quarantine fresh frozen plasma. Vox Sang 74[Suppl 1]:219–223

    Google Scholar 

  5. Flesland O, Solheim BG, Seghatchian J (2001) Transfusion medicine in Norway. Time for change. Transf Apher Sci 25:211–214

    Article  CAS  Google Scholar 

  6. Heal JM, Blumberg N (1999) The second century of ABO: and now for something completely different. Editorial. Transfusion 39:1155–1159

    Article  CAS  PubMed  Google Scholar 

  7. Baele PL, De Bruyere M, Deneys V, Dupont E, Flament J, Lambermont M, Lantine D, Steensens L, van Camp B, Waterloos H (1994) Bedside transfusion errors. A prospective survey by the Belgium Sanguis group. Vox Sang 66:117–121

    CAS  PubMed  Google Scholar 

  8. Linden JV, Wagner K, Voytovich AE, Sheehan J (2000) Transfusion errors in New Yourk State: an analysis of 10 years' experience. Transfusion 40:1207–1213

    Article  CAS  PubMed  Google Scholar 

  9. HMSO (1973) Dried human plasma. British Pharmacopoeia 67. HMSO, London

  10. Flesland O, Seghatchian J, Solheim BG (2002) The Norwegian plasma fraction project-a 12 year clinical and economic success story. Transf Apher Sci (in press)

  11. Noddeland H, Tølløfsrud S, Svennevig JL, Bentsen G, Brosstad F, Solheim BG (2002) Universal solvent/detergent-treated fresh frozen plasma (Uniplas) – rationale and clinical properties. Thrombosis research.107:S33-S37

  12. Svennevig J, Bech J, Karlsen H, Amlie E, Olsen A (1995) From a registry to a clinical information system. Development of the Datacor system at the surgery department A, Rikshospitalet. Tidsskr Nor Laegefor 115:1057–1059

    CAS  Google Scholar 

  13. Garred P, Mollnes TE, Lea T (1988) Quantification in enzyme-linked immunosorbent assay of a C3 neoepitope expressed on activated human complement factor C3. Scand J Immunol 27:329–335

    CAS  PubMed  Google Scholar 

  14. Mollnes TE, Lea T, Frøland SS, Harboe M (1985) Quantification of the terminal complement complex in human plasma by an enzyme-linked immunosorbent assay based on monoclonal antibodies against a neoantigen of the complex. Scand J Immunol 22:197–202

    CAS  PubMed  Google Scholar 

  15. O'Donnell J, Laffan MA (2001) The relationship between ABO histo-blood group, factor VIII, and von Willebrand factor. Transf Med 11:343–351

    Article  CAS  Google Scholar 

  16. Breilatt J, Dorson WJ (1984) Quantification of serum complement activation by polymeric membranes and materials. J Am Soc Artif Int Organs 7:57–63

    Google Scholar 

  17. Deppisch R, Scmitt V, Bommer J (1990) Fluid phase generation of terminal complement complex as a novel index of biocompatibility. Kidney Int 37:396–706

    Google Scholar 

  18. Svennevig JL, Tølløfsrud S, Kongsgaard U, Noddeland H, Mohr B (1996) Complement activation during and after open-heart surgery is only marginally affected by the choice of fluid for volume replacement. Perfusion 11:326–332

    CAS  PubMed  Google Scholar 

  19. Gardinali M, Cicardi M, Agostoni A, Hugli TE (1986) Complement activation in extracorporeal circulation: Physiological and pathological implications. Pathol Immunopathol Res 5:352–370

    CAS  PubMed  Google Scholar 

  20. Gasparone A, Ciavolella M, Mercogliano D (1986) Complement activation by different cardiopulmonary priming solutions. Perfusion 1:255–260

    Google Scholar 

  21. Schøtt U, Bersens O, Jaremo P (1987) Blood substitution and complement activation. Acta Anaesthesiol Scand 31:559–566

    PubMed  Google Scholar 

  22. Horowitz B, Lazo A, Grossberg H, Page G, Lippin A, Swan G (1998) Virus inactivation by solvent/detergent treatment and the manufacture of SD-plasma. Vox Sang 74[Suppl 1]:203–206

    Google Scholar 

  23. Solheim BG, Rollag H, Svennevig JL, Arafa O, Fosse E, Bergerud U (2000) Viral safety of solvent/detergent treated plasma. Transfusion 40:84–90

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgments

The Authors thank Lise Bjørnskau for excellent laboratory assistance and Dipl. Stat. Rolf Hövelmann, ClinResearch, Cologne, Germany, for statistical assistance.

Author information

Author notes

  1. Stein Tølløfsrud

    Present address: Oslo Heart Center, Postbox 2684, 0131, St. Hanshaugen, Oslo, Norway

Authors and Affiliations

  1. Department of Anaesthesiology, Rikshospitalet University Hospital, Oslo, Norway

    Stein Tølløfsrud, Harald Noddeland & Gunnar Bentsen

  2. Department of Cardiothoracic surgery, Rikshospitalet University Hospital, Oslo, Norway

    Jan Ludvig Svennevig

  3. Institute of Immunology, Rikshospitalet University Hospital, Oslo, Norway

    Tom Eirik Mollnes & Bjarte G. Solheim

Authors
  1. Stein Tølløfsrud
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Harald Noddeland
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Jan Ludvig Svennevig
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Gunnar Bentsen
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Tom Eirik Mollnes
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Bjarte G. Solheim
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Stein Tølløfsrud.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Tølløfsrud, S., Noddeland, H., Svennevig, J.L. et al. Universal fresh frozen plasma (Uniplas): a safe product in open-heart surgery. Intensive Care Med 29, 1736–1743 (2003). https://doi.org/10.1007/s00134-003-1952-3

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00134-003-1952-3

Key words

Search

Navigation