CHIlled Platelet Study (CHIPS)

The desired effect of transfusing platelets is to control sites of active bleeding without contributing to thromboembolic complications. During intra-operative and post-operative bleeding following cardiopulmonary bypass (CPB), effective hemostasis without thromboembolic complications is critical. Whether cold-stored platelets will accomplish hemostatic control as well as or better than standard, room temperature stored platelets in the bleeding CPB subject has not been determined in a large multicenter clinical trial. CHIPS (CHIlled Platelet Study) is a phase 3, multicenter, international, randomized, partial-blinded, adaptive, non-inferiority, storage duration ranging trial in adult and pediatric subjects undergoing cardiac surgery that will compare the transfusion of cold-stored (1 to 6[Degrees]C, henceforth referred to as 4[Degrees]C or cold-stored) platelets at multiple storage durations to standard room temperature stored (20 to 24[Degrees]C, henceforth referred to as 22[Degrees]C or room temperature) platelets. The goal of the trial is to determine whether platelets stored at 4[Degrees]C are non-inferior (or superior) in terms of hemostatic efficacy relative to platelets stored at 22[Degrees]C and, if so, to determine the maximum duration of storage at 4[Degrees]C that maintains non- inferiority. The data generated in this trial with cardiac surgery patients may be generalizable to other patient populations with life-threatening hemorrhage to include traumatic injury, and gastrointestinal and obstetric bleeding. If trial results support the use of cold-stored platelets, the data will be used to request FDA approval of a longer storage duration of cold-stored platelets.