Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.
Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.
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.
Inclusion Criteria:

 -  Males and Females

 -  Age 6 months to 17 years

 -  Scheduled for elective scoliosis surgery or major craniofacial surgery

 -  Written informed consent has been obtained

 -  Intraoperative hypofibrinogenemia according to definition of treatment groups

 Exclusion Criteria:

 -  Preexisting congenital or acquired coagulation disorder

 -  Medical history of estimated increased bleeding tendency

 -  Ongoing coagulation therapy

 -  Clinical signs or diagnosis of acute thromboembolism

 -  Intolerance of study drug

 -  Participation at another clinical trial

 -  Pregnant or lactating women