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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.

 

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