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

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

Condition Intervention Phase
Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Clinical Trial to Evaluate the Therapeutic Efficacy and Safety of INTERCEPT Platelets Stored for up to Seven Days After Collection

Further study details as provided by Cerus Corporation:

Primary Outcome Measures:
  • 1 hour corrected count increment for platelets [ Time Frame: One hour after platelet transfusion ]
    1-h CCI

Secondary Outcome Measures:
  • Transfusion related adverse events [ Time Frame: 24 hours after transfusion ]

Enrollment: 211
Study Start Date: October 2005
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intercept Platelets
Study patients receiving platelets that have been processed with the INTERCEPT pathogen inactivation system
Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days
pathogen inactivation of platelets for transfusion
Active Comparator: Conventional Platelets
Study patients receiving platelets processed by standard method without the INTERCEPT pathogen inactivation system
Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days
pathogen inactivation of platelets for transfusion

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.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00261924

United Kingdom
SNBTS National Science Laboratory, Edinburgh and Western General Hospital
Edinburgh, United Kingdom
Sponsors and Collaborators
Cerus Corporation
Study Director: Larry Corash, M.D. Cerus Corporation
  More Information

Responsible Party: William Reed/ Director, Clinical Research Medical Affairs, Cerus Identifier: NCT00261924     History of Changes
Other Study ID Numbers: 451-P-A-NIV
Study First Received: December 5, 2005
Last Updated: April 13, 2010

Keywords provided by Cerus Corporation:
Thrombocytopenic patients

Additional relevant MeSH terms:
Blood Platelet Disorders
Hematologic Diseases processed this record on May 22, 2017