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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00261924
First Posted: December 6, 2005
Last Update Posted: April 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cerus Corporation
  Purpose
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
Thrombocytopenia 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: Triple (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
Other Name: INTERCEPT
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
Other Name: INTERCEPT

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261924


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

Responsible Party: William Reed/ Director, Clinical Research Medical Affairs, Cerus
ClinicalTrials.gov Identifier: NCT00261924     History of Changes
Other Study ID Numbers: 451-P-A-NIV
First Submitted: December 5, 2005
First Posted: December 6, 2005
Last Update Posted: April 14, 2010
Last Verified: December 2005

Keywords provided by Cerus Corporation:
Thrombocytopenic patients

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases