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

Primary Purpose

Thrombocytopenia

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Transfusion of Pathogen Inactivated Platelets stored for 6-7 days
Sponsored by
Cerus Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thrombocytopenia focused on measuring Thrombocytopenic patients

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SNBTS National Science Laboratory, Edinburgh and Western General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intercept Platelets

Conventional Platelets

Arm Description

Study patients receiving platelets that have been processed with the INTERCEPT pathogen inactivation system

Study patients receiving platelets processed by standard method without the INTERCEPT pathogen inactivation system

Outcomes

Primary Outcome Measures

1 hour corrected count increment for platelets
1-h CCI

Secondary Outcome Measures

Transfusion related adverse events

Full Information

First Posted
December 5, 2005
Last Updated
April 13, 2010
Sponsor
Cerus Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00261924
Brief Title
Efficacy and Safety Study of Platelets Treated for Pathogen Inactivation and Stored for Up to Seven Days
Acronym
TESSI
Official Title
Clinical Trial to Evaluate the Therapeutic Efficacy and Safety of INTERCEPT Platelets Stored for up to Seven Days After Collection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cerus Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia
Keywords
Thrombocytopenic patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intercept Platelets
Arm Type
Experimental
Arm Description
Study patients receiving platelets that have been processed with the INTERCEPT pathogen inactivation system
Arm Title
Conventional Platelets
Arm Type
Active Comparator
Arm Description
Study patients receiving platelets processed by standard method without the INTERCEPT pathogen inactivation system
Intervention Type
Device
Intervention Name(s)
Transfusion of Pathogen Inactivated Platelets stored for 6-7 days
Other Intervention Name(s)
INTERCEPT
Intervention Description
pathogen inactivation of platelets for transfusion
Primary Outcome Measure Information:
Title
1 hour corrected count increment for platelets
Description
1-h CCI
Time Frame
One hour after platelet transfusion
Secondary Outcome Measure Information:
Title
Transfusion related adverse events
Time Frame
24 hours after transfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Corash, M.D.
Organizational Affiliation
Cerus Corporation
Official's Role
Study Director
Facility Information:
Facility Name
SNBTS National Science Laboratory, Edinburgh and Western General Hospital
City
Edinburgh
Country
United Kingdom

12. IPD Sharing Statement

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

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