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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-07-31

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.

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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.

Conditions

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Thrombocytopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intercept Platelets

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

Group Type EXPERIMENTAL

Transfusion of Pathogen Inactivated Platelets stored for 6-7 days

Intervention Type DEVICE

pathogen inactivation of platelets for transfusion

Conventional Platelets

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

Group Type ACTIVE_COMPARATOR

Transfusion of Pathogen Inactivated Platelets stored for 6-7 days

Intervention Type DEVICE

pathogen inactivation of platelets for transfusion

Interventions

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Transfusion of Pathogen Inactivated Platelets stored for 6-7 days

pathogen inactivation of platelets for transfusion

Intervention Type DEVICE

Other Intervention Names

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INTERCEPT

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No