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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Trial to Evaluate the Therapeutic Efficacy and Safety of INTERCEPT Platelets Stored for up to Seven Days After Collection

Conditions
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Thrombocytopenia

Intervention / Treatment
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* Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intercept Platelets<br>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<br>* pathogen inactivation of platelets for transfusion<br>* Other names: INTERCEPT;|
| Active Comparator: Conventional Platelets<br>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<br>* pathogen inactivation of platelets for transfusion<br>* Other names: INTERCEPT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 hour corrected count increment for platelets | 1-h CCI | One hour after platelet transfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion related adverse events |  | 24 hours after transfusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombocytopenic patients