Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare two different thromboelastometry (ROTEM) trigger
levels for administration of human fibrinogen concentrate (Haemocomplettan P) in the
treatment of perioperative dilutional coagulopathy during major pediatric surgery. The study
hypothesis is that administration of fibrinogen concentrate triggered by a ROTEM FibTEM MCF <
13 mm might reduce the total amount of transfused red cell concentrate during 24 hours after
start of surgery as compared to a trigger level of ROTEM FibTEM MCF < 8 mm.