Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261924
Status:
COMPLETED
Last Update Posted:
2010-04-14
First Post:
2005-12-05
Brief Title:
Efficacy and Safety Study of Platelets Treated for Pathogen Inactivation and Stored for Up to Seven Days
Sponsor:
Cerus Corporation
Organization:
Cerus Corporation
Study Overview
Official Title:
Clinical Trial to Evaluate the Therapeutic Efficacy and Safety of INTERCEPT Platelets Stored for up to Seven Days After Collection
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TESSI
Brief 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 200433EC 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None