Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.

Phase 4

Completed

• Conditions: Hemorrhage; Blood Coagulation Disorders
• Interventions: Drug: Human fibrinogen concentrate

• Registration Number: NCT01487837
• Lead Sponsor: University Children's Hospital, Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Study Start: 2012-01
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-24
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibrinogen if FibTEM < 13 mm	Human fibrinogen concentrate	Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF \< 13 mm
Fibrinogen if FibTEM < 8 mm	Human fibrinogen concentrate	Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF \< 8 mm

Primary Outcome Measures

Name	Time	Method
Total amount of transfused red cell concentrate	24 hours after start of surgery

Secondary Outcome Measures

Name	Time	Method
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
coagulation measurements	24 hours after start of surgery	influence on viscoelastic coagulation measurements (ROTEM), plasmatic coagulation testing, FXIII levels, and endogenous thrombin potential

Trial Locations

Locations (1)

Zurich University Children's Hospital; 🇨🇭 Zurich, Switzerland