Clinical use of Haemate® P in von Willebrand disease: A 25-year retrospective observational study

•A total of 663 treatments with individual laboratory evaluations were recorded•In bleeding events, Haemate® P was haemostatically effective in all patients•During the operations where Haemate® P was used, > 90% incurred no complications•The prophylactic effect of Haemate® P therapy was demonstrated•Treatment with Haemate® P was generally very well tolerated

Introductionvon Willebrand disease (VWD) is caused by dysfunction or diminished levels of von Willebrand factor (VWF). VWF-containing plasma concentrates are used for treatment of patients with VWD for whom desmopressin treatment is insufficient or contraindicated. A single-centre, retrospective observational study over a period of up to 25 years was conducted to evaluate the effectiveness and safety profile of Haemate® P (CSL Behring, Marburg, Germany), a plasma-derived, purified, pasteurised and lyophilised VWF-containing factor VIII (FVIII) concentrate.Materials and methodsThe study included 71 patients who had been treated with Haemate® P over a period of > 5 years.ResultsA total of 663 treatments with individual laboratory evaluations were recorded. Two patients had both mild type 1 VWD and haemophilia A (HA), three had HA only, 39 had type 1 VWD, 16 had type 2 VWD, nine had type 3 VWD, one had acquired VWD and one had uncategorised VWD. Haemate® P treatment indications included bleeding events (37 patients) and surgical interventions (70 patients). Thirteen patients received Haemate® P as long-term prophylaxis (n = 3), as part of rehabilitation treatment (n = 5), or in context of recovery measurements (n = 5). Treatment with Haemate® P was generally well tolerated; only one thromboembolic event occurred. In cases of bleeding events, Haemate® P was haemostatically effective in all patients. Furthermore, during operations where Haemate® P was administered, > 90% incurred no complications.ConclusionIn this retrospective observational study, Haemate® P was shown to be effective and safe for the treatment of VWD in adult patients.