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Haemophilia. 2015 Jul;21(4):481-9. doi: 10.1111/hae.12655. Epub 2015 Mar 26.

Factor XI replacement for inherited factor XI deficiency in routine clinical practice: results of the HEMOLEVEN prospective 3-year postmarketing study.

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Clinical Haematology, Centre Hospitalier de la Côte Basque, Bayonne and Laboratory MRGM, University of Bordeaux, Bordeaux, France.
Haemophilia Treatment Center, CH Le Chesnay, Le Chesnay, France.
Haematology Department, CHU Antoine Beclère, Clamart, France.
Haematology Department, CHU Nantes, Nantes, France.
Haemophilia Treatment Center, CHU Angers, Angers, France.
Haemophilia Treatment Center, Haematology Department, Hautepierre Hospital, Strasbourg, France.
Haemostasis Unit-CRTH, CHRU Hôpital Charles Nicolle, Rouen, France.
Laboratoire français du Fractionnement et des Biotechnologies (LFB), Les Ulis, France.
Hematology and Transfusion, Faculté de Médecine, Lille University Hospital, Lille 2 University, Lille, France.


Factor XI (FXI)-deficient patients may develop excessive bleeding after trauma or surgery. Replacement therapy should be considered in high-risk situations, especially when FXI levels are below 20 IU dL(-1) . HEMOLEVEN is a human plasma-derived factor XI concentrate available in France since 1992, but there are few data regarding its use by physicians. This prospective study assessed the use, efficacy and safety of HEMOLEVEN in common clinical practice. HEMOLEVEN was evaluated in FXI-deficient patients in 13 French centres in a 3-year postmarketing study. Forty-four patients (30 females, 14 males) received 67 treatments. The median age was 37 years (8 months-91 years). Basal FXI levels were <1 to 51 IU dL(-1) (median: 5.5); 29 patients were severely FXI-deficient (<20 IU dL(-1) ). FXI was administered prophylactically before 43 surgical procedures, 10 invasive procedures, 8 vaginal deliveries, or as curative treatment for six bleeds. The efficacy was assessed as excellent/good in 63, moderate in two and undetermined in two treatments. Seven patients experienced seven adverse effects, including two rated as serious: one sudden massive pulmonary embolism with fatal outcome and one case of inhibitor to FXI. HEMOLEVEN is effective for bleeding prevention in FXI deficiency. However, considering the benefit/risk ratio observed in relation to dosage in this study; firstly, it should be used sparingly due to its potential prothrombotic effect; secondly, new prescription procedures should be defined to adapt the dosage, especially in patients with intrinsic and/or acquired risk factors for thrombosis.


factor XI; factor XI concentrate; factor XI deficiency

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