Ranucci 2011.

Trial name or title	The ZEro PLASma Trial (ZEPLAST): Avoidance of Fresh Frozen Plasma in Cardiac Surgery
Methods	Prospective, randomized, double‐blind, comparative, parallel‐assigned, single‐centre clinical trial
Participants	Inclusion criteria: Combined cardiac operation with expected cardiopulmonary bypass (CPB) duration > 90 minutes At least 1 additional risk factor within the following: age > 65 years; non‐elective surgery; serum creatinine > 1.36 mg/dL; re‐do operation Exclusion criteria: Age < 18 years Receiving thienopyridines Known coagulopathy Known autoimmune disorders Participation in another RCT Pregnancy Emergency operation Baseline HCT < 35% Baseline antithrombin < 80% BSA < 1.7 m2 Withdrawal/additional exclusion criteria (exclusion following randomization): Lowest HCT on CPB < 23% Transfusions during CPB Participants randomly assigned and not withdrawn will be given investigational/place drugs in accordance with allocation All participants randomly assigned and not withdrawn will be tested 20 minutes before removal of aortic cross‐clamping with a thromboelastometric fibrinogen test ROTEM®/FIBTEM
Interventions	Intervention group: fibrinogen concentrate (Haempcpmplettan P®/CSL Behring) and prothrombin complex concentrate (PCC) (Confidex®/CSL Behring) Dose fibrinogen: according to the formula based on ROTEM®/FIBTEM test: (22 [mm] − MCF [mm]) * body weight [kg]/140 [m] = whole g fibrinogen Co‐intervention: After 15 minutes from study drug administration and in the presence of ongoing microvascular bleeding: ROTEM®/EXTEM ‐ prolonged CT time (> 80 seconds): PCC at a weight‐based dose of 7 U/kg body weight Control group: (placebo) saline Study drugs or placebo has to be administered after protamine
Outcomes	Primary outcome measures: avoidance of allogeneic blood product transfusion within 30 days (packed red cells, FFP, platelet concentrates, cryoprecipitates) Secondary outcome measures: reduction in allogeneic blood product transfusions within 30 days
Starting date	November 2011
Contact information	Marco Ranucci, MD; cardioanestesia@virgilio.it,
Notes	Estimated enrolment: 120 participants Participating hospitals: (Italy) IRCCS Policlinico San Donato Funding/relation to the industry: collaborates with CSL Behring Contacted 4 April 2012; reply 4 April 2012 Contacted 24 April 2013; reply 29 April 2013