Hamostaseologie 2019; 39(S 01): S1-S92
DOI: 10.1055/s-0039-1680225
Poster
P09 Haemophilia 3
Georg Thieme Verlag KG Stuttgart · New York

Efficacy and Safety of rVIII-SingleChain in Controlling Surgical Hemostasis

J. Mahlangu
1   University of the Witwatersrand, NHLS and Charlotte Maxeke Hospital, Johannesburg, South Africa
,
F. Karim Abdul
2   National Blood Centre, Kuala Lumpur, Malaysia
,
C. Khayat Djambas
3   Hotel-Dieu de France Hospital, Ashrafieh, Lebanon
,
J. Ong
4   Brokenshire Integrated, Davao City, Philippines
,
S. P'Ng
5   Royal Perth Hospital, Perth, Australia
,
J. Oldenburg
6   Institute of Experimental Haematology and Transfusion Medicine, University Clinic Bonn, Bonn, Germany
,
A. Brainsky
7   CSL Behring, King of Prussia, United States
,
S. Lucas
7   CSL Behring, King of Prussia, United States
,
I. Pabinger
8   Clinical Division of Haematology and Haemostaseology, Medical Clinical, Medical University Vienna, Vienna, Austria
,
for the AFFINITY investigators› Author Affiliations
Further Information

Publication History

Publication Date:
13 February 2019 (online)

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    Scientific Research Question: To investigate the safety and efficacy of rVIII-SingleChain to control surgical hemostasis in children and adults with severe hemophilia A.

    Methodology: Procedures requiring general, spinal or regional anesthesia were defined as surgery. Dosing was tailored to the type of surgery, and was adjusted based on WFH recommendations. rVIII-SingleChain was administered as either a bolus or a continuous infusion. Hemostatic efficacy was rated by the investigator using a 4 point rating scale (poor/none; moderate; good; excellent); treatment success was defined as a hemostatic efficacy rating of either excellent or good.

    Findings: In total, 32 patients aged between 5 and 64 years (median 32) underwent 43 surgical procedures. Of these, 22 surgeries were orthopedic and 21 surgeries were non-orthopedic. Seventeen surgeries were related to hemophilia or its complications, and an appendectomy was considered an emergency surgery. rVIII-SingleChain was used as a bolus dose in 35 surgeries, and as a continuous infusion in 8 surgeries. No related AEs or SAEs were observed during the perioperative period. Overall, hemostatic efficacy was rated as excellent and good in 38 (88%) and 5 (12%) surgeries, respectively. Of the orthopedic surgeries, 18 (82%) were rated as excellent, and 4 (18%) were rated as good. There were no thrombotic events and no patients developed de novo inhibitors.

    Conclusion: When given as a bolus or continuous infusion, rVIII-SingleChain was well tolerated and effective in achieving and maintaining surgical and perioperative hemostasis, with an overall treatment success rate of 100%.


     

    No conflict of interest has been declared by the author(s).