The ZEro PLASma Trial (ZEPLAST): Avoidance of Fresh Frozen Plasma in Cardiac Surgery
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Prospective, randomized, double blind trial. The rationale of the study is the concept that
fresh frozen plasma (FFP) is still largely used in cardiac surgery, despite the fact that
prothrombin complexes and fibrinogen are available.The experimental hypothesis is that
cardiac surgery patients may be operated with no use of FFP and with a coagulation factors
replacement based on fibrinogen and prothrombin complexes (when needed).
Primary endpoint: Transfusion avoidance Secondary endpoints: Transfusion limitation, massive
blood transfusion, bleeding.
Study population: high-risk adult cardiac surgery patients Sample size : 2 groups of 60
patients each