A phase 3 randomized partial blind storage duration ranging study in patients undergoing complex cardiac surgery that will compare the transfusion of cold stored platelets to standard room temperature stored platelets. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,000
Platelets stored at 1-6 degree Celsius
Platelets stored at 20-24 degrees Celsius
Hemostatic efficacy
Assessed by a bleeding score, a modified Peri-Operative bleeding score: the score ranges from 1-5. A lower score signifies a better outcome.
Time frame: 24 hours after first study platelet transfusion
Chest tube output
Assessed by volume
Time frame: 24 hours from first study platelet transfusion or ICU admit (determined from which occurs last)
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