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Thromb Haemost 2001; 86(04): 949-953
DOI: 10.1055/s-0037-1616516
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Schattauer GmbH

Elective Surgery on Factor VIII Inhibitor Patients Using Continuous Infusion of Recombinant Activated Factor VII

Plasma Factor VII Activity of 10 IU/ml Is Associated with an Increased Incidence of Bleeding
Mark P. Smith
1   Haemophilia Centre, Reference Centre for Haemostatic and Thrombotic Disorders, St Thomas’ Hospital, London, UK
,
Christopher A. Ludlam
2   Department of Haematology, the Royal Infirmary of Edinburgh, Edinburgh, UK
,
Peter W. Collins
3   Haemophilia Centre, University Hospital of Wales, Cardiff, UK
,
Charles R. M. Hay
4   Manchester Haemophilia Comprehensive Care Centre, Manchester Royal Infirmary, Manchester, UK
,
Jonathan T. Wilde
5   Department of Clinical Haematology, Queen Elizabeth Hospital, Birmingham, UK
,
Alessandro Grigeri
6   Angelo Bianchi Bonomi Haemophilia and Thrombosis Centre, IRCCS Maggiore Hospital, Milan, Italy
,
Tina Melsen
7   Novo Nordisk A/S, Bagsvaerd, Denmark
,
Geoffrey F. Savidge
1   Haemophilia Centre, Reference Centre for Haemostatic and Thrombotic Disorders, St Thomas’ Hospital, London, UK
› Author Affiliations
Further Information

Publication History

Received 20 November 2000

Accepted after revision 19 April 2001

Publication Date:
09 December 2017 (online)

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Summary

We examined recombinant activated factor VII (rVIIa) administered by continuous infusion to eight patients with inhibitors to factor VIII, undergoing elective surgery. rVIIa was infused at a fixed rate of 16.5 μg/kg/h for a median of 13.5 days (range 1-26). There was effective haemostasis at this infusion rate in only one of two minor procedures and two of six major operations. Three patients experienced excessive bleeding despite plasma factor VII activity around 10 IU/ml. Serious bleeding occurred in two other patients caused by procedural errors unrelated to rVIIa and required re-operation. The median rVIIa clearance on day 1 was 57 ml/h/kg (range 18-100) and on day 3 was 100 ml/h/kg (range 61-200). Clearance on the final infusion day was not significantly different from day 3. The infusion did not induce pathological activation of the coagulation mechanism. The only thrombotic adverse events were two episodes of superficial thrombophlebitis of the infused vein in one subject. In conclusion, the 16.5 μg/kg/h infusion rate reliably achieves plasma factor VII activity levels of 10 IU/ml, but this level does not provide reliable haemostasis.

Keywords

Recombinant factor VIIa - continuous infusion - surgery - inhibitor
 

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