NCT01487837

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: University Children's Hospital, Zurich · Academic / Other
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Coagulation Disorders
• Hemorrhage

Interventions

Type	Name	Description
DRUG	Human fibrinogen concentrate	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

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2011-12-07
• Last updated: 2014-10-27

Locations

1 site across 1 country: Switzerland