Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.

Study Overview
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Brief Summary
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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.

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

Conditions
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Blood Coagulation Disorders, Hemorrhage

Intervention / Treatment
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* Drug: Human fibrinogen concentrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fibrinogen if FibTEM < 8 mm<br>Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 8 mm | Drug: Human fibrinogen concentrate<br>* 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<br>* Other names: Haemocomplettan P, CSL Behring;|
| Experimental: Fibrinogen if FibTEM < 13 mm<br>Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 13 mm | Drug: Human fibrinogen concentrate<br>* 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<br>* Other names: Haemocomplettan P, CSL Behring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of transfused red cell concentrate |  | 24 hours after start of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coagulation measurements | influence on viscoelastic coagulation measurements (ROTEM), plasmatic coagulation testing, FXIII levels, and endogenous thrombin potential | 24 hours after start of surgery | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibrinogen, Blood coagulation disorders, Postoperative bleeding, Transfusions