Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487837
• Other study ID #: KEK-ZH-Nr. 2011-0440
• Status: Completed
• Phase: Phase 4
• First received: December 5, 2011
• Last updated: October 24, 2014
• Start date: January 2012
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemorrhage
• Hemostatic Disorders

Intervention

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

Locations

Country	Name	City	State
Switzerland	Zurich University Children's Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of transfused red cell concentrate		24 hours after start of surgery	No
Secondary	coagulation measurements	influence on viscoelastic coagulation measurements (ROTEM), plasmatic coagulation testing, FXIII levels, and endogenous thrombin potential	24 hours after start of surgery	No
Secondary	length of stay on PICU		14 days after surgery or discharge of hospital, whatever occurs earlier	No
Secondary	Additional transfusion/blood products requirements		24 hours after start of surgery	No
Secondary	Occurence of re-bleeding, surgical revision		14 days after surgery or discharge of hospital, whatever occurs earlier	No
Secondary	Occurence of (severe) adverse events		14 days after surgery or discharge of hospital, whatever occurs earlier	Yes