Status:
COMPLETED
Efficacy and Safety Study of Platelets Treated for Pathogen Inactivation and Stored for Up to Seven Days
Lead Sponsor:
Cerus Corporation
Conditions:
Thrombocytopenia
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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 ...
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 cente...
Eligibility Criteria
Inclusion
- At least 16 years old
- Written informed consent
- Thrombocytopenia, or expected to develop thrombocytopenia requiring platelet transfusion within 15 days of randomization
- Undergoing one haematopoietic stem cell transplantation and/or admitted for treatment of acute or chronic leukaemia, lymphoma, multiple myeloma or myelodysplasia
Exclusion
- Refractoriness to platelet transfusion
- Immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura, or hemolytic uremic syndrome
- Use of IL-11 (Neumega®) or other investigational platelet growth factor
- Disseminated intravascular coagulation (DIC)
- Clinically or radiologically detectable splenomegaly
- Previous participation in the study
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT00261924
Start Date
October 1 2005
End Date
July 1 2009
Last Update
April 14 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
SNBTS National Science Laboratory, Edinburgh and Western General Hospital
Edinburgh, United Kingdom