This study is a retrospective chart review study and will collect data on real world use of vonicog alfa (Recombinant Von Willebrand Factor \[rVWF\]). Von Willebrand disease (VWD) is the most common inherited bleeding disorder. rVWF is approved in Europe and UK to treat bleeding and to treat and prevent bleeding during surgeries in adults in 2018. This study will review and collect information on the treatment and bleed prevention of adult persons with inherited VWD with rVWF in UK. These data were already collected as a part of the routine care. The main aims of this study are to describe the use of rVWF in on-demand treatment of bleeding and the prevention of treatment and treatment of bleeding during surgeries. Other aims are to describe bleedings and their treatment as well as any surgeries before and after first treatment with rVWF and to gather information on the use of healthcare resources (such as hospital visits, emergency room visits, etc.).
Study Type
OBSERVATIONAL
Enrollment
34
This is a non-interventional study.
University Hospitals Birmingham
Birmingham, United Kingdom
Leeds Teaching Hospital
Leeds, United Kingdom
Liverpool University Hospital
Liverpool, United Kingdom
Royal Free London
London, United Kingdom
Imperial College Healthcare
London, United Kingdom
Manchester University
Manchester, United Kingdom
Oxford University Hospital
Oxford, United Kingdom
Number of Participants With Bleeding Episodes Treated with rVWF Between the Index Date and Following 12 Months
Bleeding episodes will be assessed based on categories of overall and annualized, type, severity, location, bleed frequency, bleed type/location and bleed severity.
Time frame: From index date up to 12 months
Number of Surgical Procedures Between the Index Date and Following 12 Months
Surgical procedures included surgery type, severity, category (emergency or elective). Data on the participants use of rVWF in the pre-, intra- and post-operative setting during the period between the index date and the following 12 months, will be stratified by VWD type, surgery type, severity, location, or treatment rationale.
Time frame: From index date up to 12 months
Number of Participants with Surgery Outcomes (Success, Failure, Complications) Between the Index Date and Following 12 Months
Surgery outcomes (success, failure, complications) will be reported.
Time frame: From index date up to 12 months
Number of Participants With VWD-Related Healthcare Resource Utilization (HRU)
HRU will include bleeding-related hospitalization rates, outpatient visits, accident and emergency visits.
Time frame: Up to 24 months
Number of Participants With Surgery Related Costs By Type
Surgery related costs by type will include length of stay in intensive care unit (ICU), rVWF consumption, factor VIII (FVIII) consumption, VWD treatment consumption, laboratory tests and examinations.
Time frame: Up to 24 months
Number of Participants With Bleeding Episodes Treated With rVWF
Bleeding episodes will be reported based on type, severity, location, treatment, and outcomes, of all recorded bleeds within 12 months prior to and 12 months following the first administration of rVWF.
Time frame: Up to 24 months
Number of Surgical Procedures
Surgical procedures will be reported based on surgery type (orthopaedic, gastro-intestinal, dental, etc), severity (major, minor), category (emergency or elective) treatment duration and outcomes, of all recorded surgeries within 12 months prior to and 12 months following the first administration of rVWF.
Time frame: Up to 24 months
Number of Participants with Surgery Outcomes (Success, Failure, Complications)
Surgery outcomes (success, failure, complications) based on average number of post-operative bleeds will be reported.
Time frame: Up to 24 months
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