NCT00261924

Efficacy and Safety Study of Platelets Treated for Pathogen Inactivation and Stored for Up to Seven Days

Clinical Trial to Evaluate the Therapeutic Efficacy and Safety of INTERCEPT Platelets Stored for up to Seven Days After Collection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Cerus Corporation · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

Objective: To determine if platelets treated for pathogen inactivation and stored for 6 to 7 days are safe and effective compared to platelets collected by the same method, stored for the same amount of time and not treated for pathogen inactivation.

Detailed description

Although the European Commission directive 2004/33/EC states that platelet preparations may be stored for 7 days in conjunction with detection or reduction of bacterial contamination, most blood centers store platelets for only 4 or 5 days. Extending the storage time could greatly improve platelet availability for patients while decreasing wastage of this limited resource.

Conditions

• Thrombocytopenia

Interventions

Type	Name	Description
DEVICE	Transfusion of Pathogen Inactivated Platelets stored for 6-7 days	pathogen inactivation of platelets for transfusion

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2005-12-06
• Last updated: 2010-04-14

Locations

1 site across 1 country: United Kingdom