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Thromb Haemost 1992; 67(03): 314-319
DOI: 10.1055/s-0038-1648439
Original Articles
Schattauer GmbH Stuttgart

Production and Therapeutic Use of a Factor XI Concentrate from Plasma

P H B Bolton-Maggs
1   The Department of Haematology, Royal Liverpool Hospital, Liverpool, UK
,
R T Wensley
2   Department of Clinical Haematology, Manchester Royal Infirmary, Manchester, UK
,
P B A Kernoff
3   Haemophilia Centre and Haemostasis Unit, The Royal Free Hospital and School of Medicine, London, UK
,
C K Kasper
4   Orthopaedic Hospital, University of Southern California, Los Angeles, California, USA
,
L Winkelman
5   Bio-Products Laboratory, Plasma Fractionation Laboratory, Churchill Hospital, Oxford, UK
,
R S Lane
6   Bio-Products Laboratory, Elstree, Herts, UK
,
J K Smith
5   Bio-Products Laboratory, Plasma Fractionation Laboratory, Churchill Hospital, Oxford, UK
› Author Affiliations
Further Information

Publication History

Received 30 July 1991

Accepted after revision 03 October 1991

Publication Date:
24 July 2018 (online)

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Summary

Factor XI deficiency is an uncommon bleeding disorder usually manifested by excessive bleeding after surgery or trauma. Until recently the only effective therapy has been fresh-frozen plasma (FFP) infusion. We describe the efficacy and safety of a new factor XI concentrate produced from human donor plasma by a modification of the method used for antithrombin III concentrate. The mean recovery of factor XI in the circulation measured on 62 occasions was approximately 91% of the injected dose, and the mean half-disappearance-time was 52 h. The concentrate was used for 31 invasive procedures in 30 patients, including 16 patients who had a definite bleeding tendency on previous occasions, with normal haemostasis being achieved in all but 1. Only 1 patient (previously experiencing allergy to FFP) experienced adverse effects during infusion. Monitoring of liver function tests and viral antibody status in suitable patients has shown no evidence of transmission of hepatitis viruses, HIV-1 or parvovirus B19.

We conclude that this concentrate provides effective treatment for patients with factor XI deficiency. Preliminary results suggest safety from virus transmission, but this needs to be established in further studies of previously untreated patients.

 

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