search
Back to results

Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.

Primary Purpose

Blood Coagulation Disorders, Hemorrhage

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Human fibrinogen concentrate
Sponsored by
University Children's Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Coagulation Disorders focused on measuring Fibrinogen, Blood coagulation disorders, Postoperative bleeding, Transfusions

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zurich University Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fibrinogen if FibTEM < 8 mm

Fibrinogen if FibTEM < 13 mm

Arm Description

Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 8 mm

Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 13 mm

Outcomes

Primary Outcome Measures

Total amount of transfused red cell concentrate

Secondary Outcome Measures

coagulation measurements
influence on viscoelastic coagulation measurements (ROTEM), plasmatic coagulation testing, FXIII levels, and endogenous thrombin potential
length of stay on PICU
Additional transfusion/blood products requirements
Occurence of re-bleeding, surgical revision
Occurence of (severe) adverse events

Full Information

First Posted
December 5, 2011
Last Updated
October 24, 2014
Sponsor
University Children's Hospital, Zurich
search

1. Study Identification

Unique Protocol Identification Number
NCT01487837
Brief Title
Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Coagulation Disorders, Hemorrhage
Keywords
Fibrinogen, Blood coagulation disorders, Postoperative bleeding, Transfusions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibrinogen if FibTEM < 8 mm
Arm Type
Active Comparator
Arm Description
Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 8 mm
Arm Title
Fibrinogen if FibTEM < 13 mm
Arm Type
Experimental
Arm Description
Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 13 mm
Intervention Type
Drug
Intervention Name(s)
Human fibrinogen concentrate
Other Intervention Name(s)
Haemocomplettan P, CSL Behring
Intervention Description
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
Primary Outcome Measure Information:
Title
Total amount of transfused red cell concentrate
Time Frame
24 hours after start of surgery
Secondary Outcome Measure Information:
Title
coagulation measurements
Description
influence on viscoelastic coagulation measurements (ROTEM), plasmatic coagulation testing, FXIII levels, and endogenous thrombin potential
Time Frame
24 hours after start of surgery
Title
length of stay on PICU
Time Frame
14 days after surgery or discharge of hospital, whatever occurs earlier
Title
Additional transfusion/blood products requirements
Time Frame
24 hours after start of surgery
Title
Occurence of re-bleeding, surgical revision
Time Frame
14 days after surgery or discharge of hospital, whatever occurs earlier
Title
Occurence of (severe) adverse events
Time Frame
14 days after surgery or discharge of hospital, whatever occurs earlier

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thorsten Haas, MD
Organizational Affiliation
Zurich University Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zurich University Children's Hospital
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34215519
Citation
Restin T, Schmugge M, Cushing MM, Haas T. Comparison between intraoperative bleeding score and ROTEM(R) measurements to assess coagulopathy during major pediatric surgery. Transfus Apher Sci. 2021 Oct;60(5):103191. doi: 10.1016/j.transci.2021.103191. Epub 2021 Jun 19.
Results Reference
derived
PubMed Identifier
25982134
Citation
Haas T, Spielmann N, Restin T, Seifert B, Henze G, Obwegeser J, Min K, Jeszenszky D, Weiss M, Schmugge M. Higher fibrinogen concentrations for reduction of transfusion requirements during major paediatric surgery: A prospective randomised controlled trial. Br J Anaesth. 2015 Aug;115(2):234-43. doi: 10.1093/bja/aev136. Epub 2015 May 15.
Results Reference
derived

Learn more about this trial

Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.

We'll reach out to this number within 24 hrs