Clinical Trial: Observational Registry of the Treatment of Glanzmann's Thrombasthenia
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Treatment of Glanzmann's Thrombasthenia: A Prospective Observational Registry
Brief Summary:
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.
Detailed Summary:
Sponsor: Novo Nordisk A/S
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Novo Nordisk A/S
Dates:
Date Received: October 7, 2011
Date Started: January 2004
Date Completion:
Last Updated: December 19, 2014
Last Verified: December 2014
