Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.

October 24, 2014 updated by: University Children's Hospital, Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8032
        • Zurich University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fibrinogen if FibTEM < 8 mm
Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 8 mm
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
Other Names:
  • Haemocomplettan P, CSL Behring
Experimental: Fibrinogen if FibTEM < 13 mm
Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 13 mm
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
Other Names:
  • Haemocomplettan P, CSL Behring

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
coagulation measurements
Time Frame: 24 hours after start of surgery
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
Time Frame: 14 days after surgery or discharge of hospital, whatever occurs earlier
14 days after surgery or discharge of hospital, whatever occurs earlier
Additional transfusion/blood products requirements
Time Frame: 24 hours after start of surgery
24 hours after start of surgery
Occurence of re-bleeding, surgical revision
Time Frame: 14 days after surgery or discharge of hospital, whatever occurs earlier
14 days after surgery or discharge of hospital, whatever occurs earlier
Occurence of (severe) adverse events
Time Frame: 14 days after surgery or discharge of hospital, whatever occurs earlier
14 days after surgery or discharge of hospital, whatever occurs earlier

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital, Zurich

Investigators

  • Principal Investigator: Thorsten Haas, MD, Zurich University Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (Estimate)

December 7, 2011

Study Record Updates

Last Update Posted (Estimate)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 24, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-Nr. 2011-0440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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