- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00261924
Efficacy and Safety Study of Platelets Treated for Pathogen Inactivation and Stored for Up to Seven Days (TESSI)
April 13, 2010 updated by: Cerus Corporation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
211
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Edinburgh, United Kingdom
- SNBTS National Science Laboratory, Edinburgh and Western General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intercept Platelets
Study patients receiving platelets that have been processed with the INTERCEPT pathogen inactivation system
|
pathogen inactivation of platelets for transfusion
Other Names:
|
Active Comparator: Conventional Platelets
Study patients receiving platelets processed by standard method without the INTERCEPT pathogen inactivation system
|
pathogen inactivation of platelets for transfusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1 hour corrected count increment for platelets
Time Frame: One hour after platelet transfusion
|
1-h CCI
|
One hour after platelet transfusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Transfusion related adverse events
Time Frame: 24 hours after transfusion
|
24 hours after transfusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Larry Corash, M.D., Cerus Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
December 5, 2005
First Submitted That Met QC Criteria
December 5, 2005
First Posted (Estimate)
December 6, 2005
Study Record Updates
Last Update Posted (Estimate)
April 14, 2010
Last Update Submitted That Met QC Criteria
April 13, 2010
Last Verified
December 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 451-P-A-NIV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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