Baxter Home
Conditions Therapies Products Services About Baxter
Training and Education Sustainability Contact Us
 

News Release

 
 

Baxter Collaborates With Gambro BCT on 7-Day Platelet Study to Speed Adoption

 

 

7-Day Platelets to Help Increase Availability of Critical Blood Component

 

DEERFIELD, Ill., May 17, 2006 – In an effort to speed adoption of a 7-day platelet protocol, Baxter Healthcare Corporation will join Gambro BCT in supporting the PASSPORT™ ( Post Approval Surveillance Study of Platelet Outcomes, Release Tested) post-market surveillance study. Baxter and Gambro will jointly manage and implement the PASSPORT Study. Baxter will submit the PASSPORT Study plan to the U.S. Food and Drug Administration (FDA) to fulfill its post-market surveillance study requirement.

 

In November 2005, Baxter received FDA clearance for the seven-day storage of platelets collected on the AMICUS® Separator and stored in Baxter's PL 2410 storage container . This clearance, which was subject to a post-market surveillance study requirement, allowed for the transfusion of leukoreduced platelets when coupled with the bioMérieux BacT/ALERT® Microbial Detection System and licensed by blood centers as determined by the FDA.

 

"By collaborating with Gambro BCT on the PASSPORT study we hope to make it faster and easier for blood centers and the industry to implement 7-day platelets and increase availability of this critical blood component,” said Kevin McCulloch, general manager for Baxter's Transfusion Therapies business.

 

About the PASSPORT Study

 

The PASSPORT study assesses the field performance of the bioMérieux BacT/ALERT System as a Release Test, the only FDA-cleared bacterial detection method that allows extension of platelet shelf-life from 5 to 7 days. It is designed to satisfy the post-market surveillance study requirement issued by the FDA and involves testing of 50,000 platelet collections. Blood centers wanting to store their platelets for up to 7 days are required by the FDA to participate in this study.

 

About Platelets

 

Platelets are transfused to people who are undergoing chemotherapy, cardio-thoracic surgery and for the treatment of other critical medical conditions. Of the approximately 2 million platelet doses transfused each year in the U.S., more than 70 percent are collected by apheresis. Since only platelets are collected during a platelet apheresis donation, individual blood donors can donate one to three full therapeutic doses of platelets rather than the one-sixth of a therapeutic dose typically collected during a whole blood donation.

 

About Baxter

 

Baxter Healthcare Corporation is the principal domestic operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.  For more information about Baxter, please visit www.baxter.com.

 

For Additional Information

Media Contacts:

     

Investor Contacts:

 
Copyright & Legal Disclaimer  |  Privacy  |   Print this page