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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:
Information provided by:
Cerus Corporation
ClinicalTrials.gov Identifier:
NCT00261924
First received: December 5, 2005
Last updated: April 13, 2010
Last verified: December 2005
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    1-h CCI


Secondary Outcome Measures:
  • Transfusion related adverse events [ Time Frame: 24 hours after transfusion ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 5, 2005
Last Updated: April 13, 2010
Health Authority: Spain: Ministry of Health

Keywords provided by Cerus Corporation:
Thrombocytopenic patients

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013