This observational registry is conducted in Europe, Asia, Africa and the United States of America (USA). The purpose of the registry is to evaluate the efficacy and safety of activated recombinant human factor VII (rFVIIa) during bleeding episodes and for the prevention of bleeding during invasive procedures/surgery in patients with Glanzmann's thrombasthenia (GT) with past or present refractoriness to platelet transfusions. Attention will be directed towards complications related to thrombo-embolic events and concomitant medications especially antifibrinolytics.
Study Type
OBSERVATIONAL
Enrollment
218
A prospective, observational multi-national registry collecting data and evaluating the efficacy and safety of rFVIIa in patients with GT with past or present refractoriness to platelet transfusions. The registry will also collect data from a broader range of GT patients treated with systemic haemostatic treatment (with or without antifibrinolytic drugs or other agents) used in the clinics. Data collection will continue for a maximum of six years. Baseline data as well as data obtained during either bleeding episodes or invasive procedures/surgeries will be recorded in the registry.
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States
Unnamed facility
Algiers, Algeria
Unnamed facility
Vienna, Austria
For bleeding episodes: Overall efficacy evaluated by the caregiver/patient
Time frame: within 30 days of end of treatment
For surgery including invasive and dental procedures: Haemoglobin level
Time frame: prior to surgery and 24 hours after surgery
For surgery including invasive and dental procedures: Overall haemostatic evaluation by the surgeon
Time frame: 24 hours after surgery
Changes in laboratory parameters (prothrombin time, platelet count, fibrinogen), if available
Time frame: at the time of administration and two hours after the administration of rFVIIa
Adverse Events (AEs)
Time frame: during treatment episodes
Serious Adverse Events (SAEs)
Time frame: during treatment episodes
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Unnamed facility
Brussels, Belgium
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Paris La Défense Cedex, France
Unnamed facility
Mainz, Germany
Unnamed facility
Budapest, Hungary
Unnamed facility
Rome, Italy
Unnamed facility
Alphen aan den Rijn, Netherlands
...and 5 more locations