- ClinicalTrials.gov ID: NCT04834414
- Recruiting participants (Starts Jul. 1, 2021)
- Not accepting healthy volunteers
- UTSW Principal Investigator: PHILIP E GREILICH
summary
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.
objective
This project has the following Specific Aims: Specific Aim 1. Test the hypothesis that platelets stored at 4°C are non-inferior (or superior) in hemostatic efficacy to standard, room temperature platelets stored at 22°C when transfused to adult and pediatric patients requiring complex cardiac surgery who are actively bleeding. Specific Aim 2. If the hypothesis in Specific Aim 1 is supported, determine the maximum duration (up to 21 days) of storage at 4°C that maintains non-inferiority. Specific Aim 3. Demonstrate comparable safety of administration of platelets stored at 4°C versus platelets stored at 22°C to adult and pediatric patients requiring cardiac surgery who are actively bleeding.