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

Phase 3

Completed

• Conditions: Thrombocytopenia
• Interventions: Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days

• Registration Number: NCT00261924
• Lead Sponsor: Cerus Corporation

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.

Study Timeline

• Study Start: 2005-10
• Status Verified: 2005-12
• Study First Submitted: 2005-12-05
• Study First Submitted QC: 2005-12-05
• Study First Posted: 2005-12-06
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2010-04-13
• Last Update Posted: 2010-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intercept Platelets	Transfusion of Pathogen Inactivated Platelets stored for 6-7 days	Study patients receiving platelets that have been processed with the INTERCEPT pathogen inactivation system
Conventional Platelets	Transfusion of Pathogen Inactivated Platelets stored for 6-7 days	Study patients receiving platelets processed by standard method without the INTERCEPT pathogen inactivation system

Primary Outcome Measures

Name	Time	Method
1 hour corrected count increment for platelets	One hour after platelet transfusion	1-h CCI

Secondary Outcome Measures

Name	Time	Method
Transfusion related adverse events	24 hours after transfusion

Trial Locations

Locations (1)

SNBTS National Science Laboratory, Edinburgh and Western General Hospital; 🇬🇧 Edinburgh, United Kingdom