September 26, 2020
THOR Network investigators have been awarded over 26 million dollars by the US Department of Defense for a research program that will examine the efficacy and safety of cold stored platelets for patients with active bleeding.
The funding will support the Chilled Platelet Study (CHIPS), which is a phase III, multicenter, randomized, double blinded, adaptive, non-inferiority, storage duration ranging trial in 1000 cardiac surgery patients with active bleeding. The adaptive trial design will allow for a maximum storage duration of up to 21 days in the cold storage group. The control group will be room temperature stored platelets with a maximum of 5-7 days, and the primary outcome is a well validated 5-point bleeding score. The trial is expected to begin in the summer of 2021.
The principal investigators of the trial are Drs. Phil Spinella, Nicole Zantek, and Marie Steiner. The CHIPS Steering Committee includes the following THOR Network members, Drs. Geir Strandenes, Andre Cap, James Stubbs, Mark Yazer, Pampee Young, and Paul Ness. The Clinical Coordination Center will be led by Dr. Phil Spinella at Washington University in St. Louis, and the Data Coordination Center will be led by Dr. John Van Buren at the University of Utah. The adaptive trial design will be led by Dr. Roger Lewis of Berry Consultants.
The cold platelet research program also includes an in vitro platelet characterization study that will include all platelet collection platforms, storage solutions, and pathogen reduction. This work will be led by Drs. Susan Shea and Kimberly Thomas in the Spinella Lab at Washington University in St. Louis, and by Dr. Kristin Cardenas in the Bynum Lab at the US Army Institute of Surgical Research. The cold stored platelet program is predicated on the seminal in vitro work that has been produced by COL Andre Cap at the USAISR and the pilot RCT that has been recently published by CDR Geir Strandenes, Norwegian Armed Forces Medical Services, and Haukeland University Hospital, Bergen, Norway.
The THOR Network is proud to lead the way in examining the efficacy and safety of cold stored platelets for actively bleeding patients. For more information about the THOR Network visit the website at https://RDCR.org.
Philip C. Spinella, MD FCCM
Co-Chair, THOR Network | Professor, Pediatrics | Director, Translational Research Program | Division of Critical Care, Department Pediatrics | Washington University in St Louis | St Louis, Missouri USA