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

This study has been completed.
Sponsor:
Information provided by:
Cerus Corporation
ClinicalTrials.gov Identifier:
NCT00261924
First received: December 5, 2005
Last updated: April 13, 2010
Last verified: December 2005

December 5, 2005
April 13, 2010
October 2005
July 2009   (final data collection date for primary outcome measure)
1 hour corrected count increment for platelets [ Time Frame: One hour after platelet transfusion ] [ Designated as safety issue: No ]
1-h CCI
Not Provided
Complete list of historical versions of study NCT00261924 on ClinicalTrials.gov Archive Site
Transfusion related adverse events [ Time Frame: 24 hours after transfusion ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Thrombocytopenia
Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days
pathogen inactivation of platelets for transfusion
Other Name: INTERCEPT
  • Experimental: Intercept Platelets
    Study patients receiving platelets that have been processed with the INTERCEPT pathogen inactivation system
    Intervention: Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days
  • Active Comparator: Conventional Platelets
    Study patients receiving platelets processed by standard method without the INTERCEPT pathogen inactivation system
    Intervention: Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00261924
451-P-A-NIV
Yes
William Reed/ Director, Clinical Research Medical Affairs, Cerus
Cerus Corporation
Not Provided
Study Director: Larry Corash, M.D. Cerus Corporation
Cerus Corporation
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP