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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
57
Administration of human fibrinogen concentrate (30 mg / kg bw) over 15 min Repetition if hourly intraoperative ROTEM measurements revealed hypofibrinogenemia according to treatment group definition
Zurich University Children's Hospital
Zurich, Switzerland
Total amount of transfused red cell concentrate
Time frame: 24 hours after start of surgery
coagulation measurements
influence on viscoelastic coagulation measurements (ROTEM), plasmatic coagulation testing, FXIII levels, and endogenous thrombin potential
Time frame: 24 hours after start of surgery
length of stay on PICU
Time frame: 14 days after surgery or discharge of hospital, whatever occurs earlier
Additional transfusion/blood products requirements
Time frame: 24 hours after start of surgery
Occurence of re-bleeding, surgical revision
Time frame: 14 days after surgery or discharge of hospital, whatever occurs earlier
Occurence of (severe) adverse events
Time frame: 14 days after surgery or discharge of hospital, whatever occurs earlier
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