Blood Coagulation Disorders, Hemorrhage
Conditions
Keywords
Fibrinogen, Blood coagulation disorders, Postoperative bleeding, Transfusions
Brief 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.
Interventions
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
Sponsors
University Children's Hospital, Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total amount of transfused red cell concentrate | 24 hours after start of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| coagulation measurements | 24 hours after start of surgery | influence on viscoelastic coagulation measurements (ROTEM), plasmatic coagulation testing, FXIII levels, and endogenous thrombin potential |
| length of stay on PICU | 14 days after surgery or discharge of hospital, whatever occurs earlier | — |
| Additional transfusion/blood products requirements | 24 hours after start of surgery | — |
| Occurence of re-bleeding, surgical revision | 14 days after surgery or discharge of hospital, whatever occurs earlier | — |
| Occurence of (severe) adverse events | 14 days after surgery or discharge of hospital, whatever occurs earlier | — |
Countries
Switzerland
Outcome results
None listed