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Thromb Haemost 1995; 74(02): 622-625
DOI: 10.1055/s-0038-1649787
Original Article
Clinical Studies
Schattauer GmbH Stuttgart

Pharmacokinetics and Tolerability of Factor XIII Concentrates Prepared from Human Placenta or Plasma: a Crossover Randomised Study

H H Brackmann
1   The Institut für experimentelle Hämatologie und Transfusionsmedizin, Universität Bonn, Germany
,
R Egbring
2   The Philipps-Universität Marburg, Germany
,
A Ferster
3   The Hôpital des Enfants Reine Fabiola, Brussels, Belgium
,
P Fondu
4   The Hôpital Brugmann, Brussels, Belgium
,
J M Girardel
5   The Centre Hospitalier de Belfort, France
,
W Kreuz
6   The Universitäts-Kinderklinik, Frankfurt, Germany
,
R Masure
7   The Private practice, Brussels, Belgium
,
K Miloszewski
8   The St. James Hospital, Leeds, UK
,
J Stibbe
9   The University Hospital Rotterdam, The Netherlands
,
R Zimmermann
10   The Rehabilitationsklinik Heidelberg, Germany
,
U Krzensk
11   The Behringwerke AG, Marburg, Germany
,
A Hoos
11   The Behringwerke AG, Marburg, Germany
› Author Affiliations
Further Information

Publication History

Received 30 September 1994

Accepted after revision 24 March 1995

Publication Date:
04 July 2018 (online)

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Summary

The pharmacokinetics and tolerability of factor XIII (FXIII) from plasma were compared with those of FXIII from placenta in a randomised, double-blind, crossover study involving 13 patients with congenital FXIII deficiency. Both FXIII activity and FXIII antigen were monitored. No difference was seen in the mean half-lives of the two preparations (9.3 days and 9.1 days for plasma and placenta FXIII activity, respectively). Response was similar for both preparations, but was slightly greater for FXIII from plasma.

Similar results were found for recovery (65% vs 60%). The area under the data completed by extrapolation was significantly higher for FXIII from plasma. No differences between preparations in terms of efficacy or tolerability were observed. It can be concluded that treatment with FXIII concentrate from plasma is as efficient as with FXIII concentrate from placenta in terms of recovery and half-life. Both preparations were equivalent in terms of safety during the observation period. With the administration of monthly injections of approximately 30 U/kg serious bleeding events were prevented and no other serious adverse events occurred.

 

  • References

  • 1 Israels ED, Paraskcvas F, Israels LG. Immunological studies of coagulation factor XIII. J Clin Invest 1973; 32: 2398-2403
    PubMedGoogle Scholar
  • 2 Bohn II, Becker W, Trobisch II. Die molekulare Struktur der fibrinstabilisierenden Faktoren des Mensehen. II. Vergleiehcnde immunologisehe Untersuehungen von Faktor-XIII-Mangelplasmen und Normalplasma Blut 1973; 26: 303-311
    CrossrefPubMedGoogle Scholar
  • 3 Duekert F. Documentation of the plasma factor XIII deficiency in man. Ann NY AeadSei 1972; 202: 190-199
    PubMedGoogle Scholar
  • 4 Berliner SH, Lusky A, Zivelin A, Modan M. Hereditary factor XIII deficiency: Report of four families and definition of the carrier state. Br J Haematol 1984; 56: 495-505
    CrossrefPubMedGoogle Scholar
  • 5 Rasehe H. Blutgerinnungsfaktor XIII und Fibrinstahilisicrung. Klin Wochenschr 1975; 53: 1137-1145
    CrossrefPubMedGoogle Scholar
  • 6 Baer U. Klinische Aspekte bei Anwendung des FXIII. In: Symposium liber Gerinnungsfaktor XIII. Bruckner WL. ed Munich, Vienna, Baltimore: Urban & Schwarzenberg; 1983: 105-116
    Google Scholar
  • 7 McDonagh J. Structure and function of factor XIII. In: Hemostasis and thrombosis. Basic principles and clinical practice. Colman RW, Hirsh J, Marder VJ, Salzman EW. eds 2. nd Edn Philadelphia: JB Lippincott Co; 1987: 289-300
    Google Scholar
  • 8 Miloszewski KJ A, Losowsky MS. Fibrin stabilisation and factor XIII deficiency. In: Fibrinogen, Fibrin Stabilisation and Fibrinolysis. Francis JL. ed Chichester: Ellis Horwood Ltd; 1988: 175-202
    Google Scholar
  • 9 Kröniger A, Egbring R. Long-term treatment (12 years) with factor XIII concentrate in a patient with congenital factor XIII deficiency. In: Factor XIII and Fibronectin. Egbring R, Klingemann HG. eds Marburg: Medizinische Verlagsgesellschaft; 1983: 41-44
    Google Scholar
  • 10 Hilfenhaus J, Weidmann E. Pasteurization as an efficient method to inactivate blood borne viruses in Factor XIII concentrates. Arzneimittel-forschung 1986; 36 (04) 621-625
    PubMedGoogle Scholar
  • 11 Hilfenhaus J, Mauler R, Friis R, Bauer H. Safety of human blood products: Inactivation of retrovirusus by heart treatment at 60° C (42045). Proc Soc Exp Biol Med 1985; 178: 580-584
    CrossrefPubMedGoogle Scholar
  • 12 Dati F, Barthels M, Keller F. Determination of Coagulation Factor FXIII by a new Photometric Method. Abstract No. 0194 43rd National Meeting of the American Association for Clinical Chemistry; Washington D. C: 28.07.1991
    Google Scholar
  • 13 Fickenscher K, Aab A, Stiiber W. A photometric assay for blood coagulation Factor XIII. Thromb Haemost 1991; 65 (05) 535-540
    Article in Thieme ConnectPubMedGoogle Scholar
  • 14 Gibaldi M, Perrier D. Pharmacokinetics. New York: Basel: Marcel Dekker; 1982: 445-449
    Google Scholar
  • 15 Jones B, Kenward MG. Design and Analysis of Cross-Over Trials. New York: Chapman and Hall Ltd; 1989
    Google Scholar
  • 16 Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinetics Biopharm 1987; 15 (06) 657-80
    CrossrefPubMedGoogle Scholar
  • 17 Zimmermann R, Ehlers W, Manz F, Meinrenken W, Egbring R, Gemmeke H. Ein neuer Fall von schwerem Faktor XIII-Mangel. Untersuehungen zum Verhalten der Untereinheiten und des Turnover des fibrinstabilisierenden Faktors Blut 1977; 35: 457-464
    CrossrefPubMedGoogle Scholar