NCT01476423

Observational Registry of the Treatment of Glanzmann's Thrombasthenia

Treatment of Glanzmann's Thrombasthenia: A Prospective Observational Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 218 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Bleeding Disorder
• Glanzmann's Disease

Interventions

Type	Name	Description
DRUG	activated recombinant human factor VII	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.

Timeline

• Start date: 2004-01-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-11-22
• Last updated: 2014-12-23

Locations

15 sites across 15 countries: United States, Algeria, Austria, Belgium, Bulgaria, France, Germany, Hungary, Italy, Netherlands, Pakistan, Spain, Sweden, Switzerland, United Kingdom