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

  • United Kingdom
      • 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
Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days
pathogen inactivation of platelets for transfusion
Other Names:
  • 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 Names:
  • INTERCEPT

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

Cerus Corporation

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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