STBTC makes first delivery of cold-stored platelets
The South Texas Blood & Tissue Center has delivered the nation’s first unit of platelets with an extended shelf life to Citizens Medical Center in Victoria, thanks to a process recently approved by the U.S. Food and Drug Administration.
The “cold-stored platelets” for civilian use are refrigerated within two hours of collection and have a shelf life of 14 days. The platelets are used for the treatment of actively bleeding patients when conventional platelets are not available, or their use is not practical.
Under current practices, platelets are stored at room temperature and have a shelf life of five days, with the first 48 hours of that time typically required for testing and distribution to hospitals.
Refrigeration extends the platelets’ viability for the treatment of actively bleeding patients when conventional platelets are not available, or their use is not practical. The cold-stored platelets are intended only to treat bleeding and are not indicated to prevent bleeding in patients with low platelet counts, such as cancer patients.
STBTC is the first civilian blood center in the United States to receive a supplemental approval to produce cold-stored platelets for use in treating actively bleeding patients through day 14 of storage when conventional platelet products are unavailable, or their use is not practical.
Accompanying the delivery was Dr. Donald Jenkins, Professor of Surgery, Vice Chair for Quality, and Associate Deputy Director of the Military Health Institute at the University of Texas Health Science Center in San Antonio. Dr. Jenkins worked on developing the system for cold-stored platelets while at the Mayo Clinic in Rochester, Minnesota, and continued his research in San Antonio.
“This is something we hope the world will take on, especially in the United States, and there’s no better time than during this pandemic to take advantage of this,” he said. “There’s nothing in the process that changes. We put the platelet bag in the refrigerator instead of leaving it on an agitator on the shelf at room temperature.”
Platelets are a key blood component constantly in demand for treating trauma, severely bleeding patients and maternal hemorrhage, which is a special challenge for hospitals outside of large urban centers. There also is a growing need for platelets for use in transplant surgeries and other medical conditions.
Hemorrhage is the single largest cause of pregnancy/delivery deaths in the United States, according to statistics compiled by the Centers for Disease Control and Prevention. Platelets are the blood component that begins the process of healing a break in blood vessels and often are transfused in cases of extreme bleeding.
Public, private and military collaborators, as well as medical device manufacturers, have worked on the discovery and development of the new process.
The U.S. military and other researchers who are part of the THOR (Trauma Hemostasis & Oxygenation Research) group brought the process to light. The Mayo Clinic in Rochester, Minnesota, was the first hospital to produce and transfuse three-day cold-stored platelets. Last year, the military received an FDA variance to produce 14-day cold-stored platelets. The STBTC licensed 14-day cold-stored platelets are approved for collection on the Trima Accel Automated Blood Collection System from Terumo BCT.
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