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

Cerus

Status and phase: Completed; Phase 3

Conditions: Thrombocytopenia

Treatments: Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days

Study type: Interventional

Funder types: Industry

Identifiers

NCT00261924

451-P-A-NIV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 211 patients

Sex: All

Ages: 16+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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211 participants in 2 patient groups

Intercept Platelets

Experimental group

Description:

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

Treatment:

Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days

Conventional Platelets

Active Comparator group

Description:

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

Treatment:

Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days