{"id":3968,"date":"2022-03-15T09:40:10","date_gmt":"2022-03-15T09:40:10","guid":{"rendered":"https:\/\/wilate.com\/ca\/?page_id=3968"},"modified":"2022-12-22T13:38:53","modified_gmt":"2022-12-22T13:38:53","slug":"surgery","status":"publish","type":"page","link":"https:\/\/wilate.com\/ca\/surgery\/","title":{"rendered":"Surgery"},"content":{"rendered":"\t\t
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\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Surgery<\/span><\/h1>

Surgery poses a serious risk of bleeding in people with von Willebrand disease and necessitates careful monitoring and management.1<\/sup><\/strong><\/p>


<\/sup><\/strong>Normalising the activity of both von Willebrand factor and factor VIII is important to maintain haemostasis during surgery to minimise the risk of prolonged or excessive bleeding.1, 2<\/sup> The efficacy of wilate\u00ae<\/sup><\/span> for surgical prophylaxis has been demonstrated in clinical trials and is supported by real-world experience for major and minor surgeries, in patients with all types of VWD. There have been no reports of thromboembolism or factor VIII accumulation in any clinical study of wilate\u00ae<\/sup><\/span>.3, 4<\/sup><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Requirements for managing surgery<\/span><\/h2>\n

in people with von Willebrand disease<\/em><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Normalisation of both VWF and FVIII to ensure normal haemostasis1<\/sup><\/span><\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Avoidance of FVIII accumulation with repeated dosing of VWF\/FVIII which may increase risk of thrombosis5<\/sup><\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Close monitoring of VWF and FVIII levels to avoid under- or over-dosing6<\/sup><\/span><\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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VWF and FVIII in wilate\u00ae<\/sup><\/span><\/h2>

show parallel decay curves, and no FVIII accumulation has been reported in clinical studies, even with repeat dosing 6*<\/sup><\/em><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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* the indicated use is for prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contra-indicated. FVIII:C: FVIII clotting activity; VWF:RCo: VWF Ristocetin Cofactor.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Parallel decay of\n<\/span>VWF:RCo and FVIII:C<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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May simplify dosing and monitoring<\/span> using either VWF or FVIII<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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VWF and FVIII in wilate\u00ae<\/sup><\/span><\/h2>

show parallel decay curves, and no FVIII accumulation has been reported in clinical studies, even with repeat dosing 6*<\/sup><\/em><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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* the indicated use is for the prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease, when desmopressin treatment alone is ineffective or contra-indicated. FVIII:C: FVIII clotting activity; FVIII: factor VIII, VWF: von Willebrand factor; VWF:Ag: von Willebrand factor Antigen; VWF:RCo: VWF Ristocetin Cofactor<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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VWF and FVIII in wilate\u00ae<\/sup><\/span><\/h2>

show parallel decay curves, and no FVIII accumulation has been reported in clinical studies, even with repeat dosing 6*<\/sup><\/em><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Representative recovery profile in an 18 year old female patient with type 3 von Willebrand disease<\/span> undergoing leg elongation surgery4<\/sup><\/em><\/p>

\u00a0<\/p>

No FVIII accumulation<\/span> seen despite repeat dosing4<\/sup><\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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* the indicated use is for the prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease, when desmopressin treatment alone is ineffective or contra-indicated. FVIII:C: FVIII coagulation activity; FVIII: factor VIII and VWF: von Willebrand factor; VWF:RCo: VWF ristocetin cofactor.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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VWF and FVIII in wilate\u00ae<\/sup><\/span><\/h2>

show parallel decay curves, and no FVIII accumulation has been reported in clinical studies, even with repeat dosing 6*<\/sup><\/em><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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* the indicated use is for the prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease, when desmopressin treatment alone is ineffective or contra-indicated. FVIII: factor VIII; VWD: von Willebrand disease<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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reported in any clinical study<\/span> or published real-world clinical experience3, 4, 7\u20139<\/sup><\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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97% of major & minor surgeries<\/span><\/h2>\n

were managed successfully with wilate\u00ae<\/sup><\/span>, with no reports of thromboembolism or FVIII accumulation in any clinical study3<\/sup><\/span><\/em><\/h3>\n

WONDERS: Prospective, open-label, uncontrolled Phase III study of wilate\u00ae<\/sup><\/span> in surgery<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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FVIII: factor VIII<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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97% of major & minor surgeries<\/span><\/h2>\n

were managed successfully with wilate\u00ae<\/sup><\/span>, with no reports of thromboembolism or FVIII accumulation in any clinical study3<\/sup><\/em><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Overall efficacy rated as successful* in 97% of surgeries<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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* IDMC-adjudicated treatment success rating based on haemostatic efficacy assessment (intraoperatively by surgeon and postoperatively by investigator) using objective 4-point scale (excellent, good, moderate, none). FVIII: factor VIII<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Success in major<\/span>\nsurgeries (20\/21)<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Success in minor<\/span>\nsurgeries (9\/9)<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Success in 21 surgeries in 20 patients<\/span> with type 3 von Willebrand disease<\/span><\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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97% of major & minor surgeries<\/span><\/h2>\n

were managed successfully with wilate\u00ae<\/sup><\/span>, with no reports of thromboembolism or FVIII accumulation in any clinical study3<\/sup><\/em><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Median dose per infusion of wilate\u00ae<\/sup><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Loading dose<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Maintenance\ndose<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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97% of major & minor surgeries<\/span><\/h2>\n

were managed successfully with wilate\u00ae<\/sup><\/span>, with no reports of thromboembolism or FVIII accumulation in any clinical study3<\/sup><\/em><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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FVIII: factor VIII<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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97% of major & minor surgeries<\/span><\/h2>

were managed successfully with wilate\u00ae<\/sup><\/span>, with no reports of thromboembolism or FVIII accumulation in any clinical study3<\/sup><\/em><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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*0 = pre-surgery loading dose. Error bars represent standard error of the mean. FVIII: factor VIII; FVIII:C: FVIII coagulation activity; VWF:Ag: VWF antigen; VWF:RCo: VWF ristocetin cofactor.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Real-world experience<\/span><\/h2>

with wilate\u00ae<\/sup><\/span> in surgery: the WIL-20 study7<\/sup><\/span><\/em><\/h3>

WIL-20: Prospective, observational Phase IV study on the use of wilate\u00ae<\/sup><\/span> in
von Willebrand disease<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"_2-3_12_@2x\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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*Diagnosis data not available.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"_2-3_12@2x\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Real-world experience<\/span><\/h2>\n

with wilate\u00ae<\/sup><\/span> in surgery: the WIL-20 study7<\/sup><\/em><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Excellent<\/span> or good<\/span> effectiveness in surgical prophylaxis for*<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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* IDMC-adjudicated treatment success rating based on haemostatic efficacy assessment (intraoperatively by surgeon and postoperatively by investigator) using objective 4-point scale (excellent, good, moderate, none).<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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of 46 major<\/span> surgeries<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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of 52 minor<\/span> surgeries<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\tEffectiveness of wilate\u00ae<\/sup><\/span> rated as \u2018excellent\u2019<\/span> or \u2018good\u2019<\/span> in 99% of surgeries\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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of all surgeries<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Real-world experience<\/span><\/h2>\n

with wilate\u00ae<\/sup><\/span> in surgery: the WIL-20 study7<\/sup><\/em><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Median dose of wilate\u00ae per procedure<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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*Haemostatic effectiveness assessment after surgery using objective 4-point scale (excellent, good, moderate, none). Effectiveness rating not available for one minor surgery.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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for major<\/span> surgeries range: (22\u2013500 IU\/kg)<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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for minor<\/span> surgeries
range: (6\u2013680 IU\/kg)<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Reported in the WIL-20 study<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Information about on-demand treatment with wilate\u00ae<\/sup><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tTreat on-demand<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Prevention of bleeding with wilate\u00ae<\/sup><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tProphylaxis<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Use of wilate\u00ae<\/sup> in people with von Willebrand disease<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tTolerability<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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References<\/h4>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    \n \t
  1. Leebeek FWG and Eikenboom JCJ. N Engl J Med<\/em> 2016; 375:2067-80.<\/li>\n \t
  2. Miesbach W and Berntorp E. Eur J Haematol<\/em> 2017; 98:121-27.<\/li>\n \t
  3. Srivastava A et al. Haemophilia<\/em> 2017; 23:264-72.<\/li>\n \t
  4. Windyga J and von Depka-Prondzinski M. Thromb Haemost<\/em> 2011; 105:1072-9.<\/li>\n \t
  5. Mannucci PM. N Engl J Med<\/em> 2004; 351:683-94.<\/li>\n \t
  6. Kessler CM et al. Thromb Haemost<\/em> 2011; 106:279-88.<\/li>\n \t
  7. Sholzberg M et al. TH Open<\/em> 2021; 5:e264-72.<\/li>\n \t
  8. Batty P et al. Haemophilia<\/em> 2014; 20:846-53.<\/li>\n \t
  9. Khair K et al. Haemophilia<\/em> 2015; 21:e44-50.<\/li>\n<\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

    Surgery Surgery poses a serious risk of bleeding in people with von Willebrand disease and necessitates careful monitoring and management.1 Normalising the activity of both von Willebrand factor and factor VIII is important to maintain haemostasis during surgery to minimise the risk of prolonged or excessive bleeding.1, 2 The efficacy of wilate\u00ae for surgical prophylaxis […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-3968","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nPrevent bleeding in surgery for people living with vwd<\/title>\n<meta name=\"description\" content=\"Surgery poses a serious risk of bleeding in people with von Willebrand disease and necessitates careful monitoring and management\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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