Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.

A Phase IV, Randomized, Single Center, Parallel Group Trial of Human Fibrinogen Concentrate (Haemocomplettan) in the Treatment of Dilutional Coagulopathy During Major Pediatric Surgery

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