Cardiac Surgery Clinical Trial
Official title:
Randomized Controlled Trial Comparing Dimethyl Sulfoxide Cryopreserved Platelets to Liquid Stored Platelets in Patients Undergoing Cardiopulmonary Bypass Surgery (CRYPTICS)
A randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery.
A randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery. Patients planning to undergo Cardiopulmonary Bypass Surgery with risk factors for significant bleeding post-surgery will be approached. Subjects will be randomized in a 1:1 ratio to receive either Cryopreserved Platelets or Liquid Stored Platelets. Eligible subjects will undergo Cardiopulmonary Bypass Surgery and at the completion of bypass and heparin reversal subjects will likely be assessed for eligibility before coming off bypass. Study platelets will be given either intraoperatively after heparin reversal and return of active clotting time (ACT) to < 140 sec or post operatively (after chest closure). A single interim analysis is planned after 150 subjects are treated (75 in each treatment arm) to assess whether the study can be stopped for overwhelming efficacy or if an increase in sample size is warranted to maintain desired conditional power. ;
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