Evaluation of StablePlate Rx in Thrombocytopenic Canine Patients: A Multicenter Clinical Trial
Principal Investigator: Robert Goggs
DESCRIPTION (provided by applicant):
Private and academic practices involved in emergency medicine currently manage hemorrhage due to primary hemostatic defects using whole blood, platelet concentrates or DMSO cryopreserved platelets when these products are available. Most hemorrhage is managed without transfused platelets due to a limited availability of suitable blood products. Single case reports and small review studies suggest that platelet transfusion is preferable over whole blood administration. A previous clinical study evaluated a lyophilized platelet product suggesting a role in management of hemorrhage caused by thrombocytopenia, but that product is no longer available. A novel trehalose‐stabilized lyophilized canine platelet product (StablePlate Rx) has been developed by Cellphire. Preclinical studies suggest that the StablePlate Rx is safe in the dog at multiple dosing ranges. This study aims to evaluate the safety of StablePlate Rx in canine patients for the control of life‐threatening hemorrhage secondary to thrombocytopenia, and to evaluate the efficacy of StablePlate Rx in canine patients demonstrating lifethreatening hemorrhage secondary to thrombocytopenia.