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

This study is currently recruiting participants.

Verified by Baxter Healthcare Corporation, December 2005

Sponsors and Collaborators:	Baxter Healthcare Corporation Cerus Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00261924

Purpose

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.

Condition	Intervention	Phase
Thrombocytopenia	Procedure: Platelet transfusion	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Active Control, Parallel Assignment

Further study details as provided by Baxter Healthcare Corporation:

Estimated Enrollment:

200

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261924

Contacts

Contact: Clinical Registration

CDE ClinRegistration@baxter.com

Locations

United Kingdom
SNBTS National Science Laboratory, Edinburgh and Western General Hospital	Recruiting
Edinburgh, United Kingdom

Sponsors and Collaborators

Baxter Healthcare Corporation

Cerus Corporation

Investigators

Study Director:

Jocelyne Flament, M.D.

Baxter Healthcare Corporation

More Information

Study ID Numbers:	451-P-A-NIV
Study First Received:	December 5, 2005
Last Updated:	August 9, 2006
ClinicalTrials.gov Identifier:	NCT00261924
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Baxter Healthcare Corporation:

Thrombocytopenic patients

Study placed in the following topic categories:

Thrombocytopathy
Thrombocytopenia
Hematologic Diseases
Blood Platelet Disorders

ClinicalTrials.gov processed this record on January 14, 2009