Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Children's Hospital, Zurich
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01487837
First received: December 5, 2011
Last updated: March 18, 2014
Last verified: March 2014

December 5, 2011
March 18, 2014
January 2012
September 2014   (final data collection date for primary outcome measure)
Total amount of transfused red cell concentrate [ Time Frame: 24 hours after start of surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01487837 on ClinicalTrials.gov Archive Site
  • coagulation measurements [ Time Frame: 24 hours after start of surgery ] [ Designated as safety issue: No ]
    influence on viscoelastic coagulation measurements (ROTEM), plasmatic coagulation testing, FXIII levels, and endogenous thrombin potential
  • length of stay on PICU [ Time Frame: 14 days after surgery or discharge of hospital, whatever occurs earlier ] [ Designated as safety issue: No ]
  • Additional transfusion/blood products requirements [ Time Frame: 24 hours after start of surgery ] [ Designated as safety issue: No ]
  • Occurence of re-bleeding, surgical revision [ Time Frame: 14 days after surgery or discharge of hospital, whatever occurs earlier ] [ Designated as safety issue: No ]
  • Occurence of (severe) adverse events [ Time Frame: 14 days after surgery or discharge of hospital, whatever occurs earlier ] [ Designated as safety issue: Yes ]
  • coagulation measurements [ Time Frame: 24 hours after start of surgery ] [ Designated as safety issue: No ]
    influence on viscoelastic coagulation measurements (ROTEM), plasmatic coagulation testing, FXIII levels, and endogenous thrombin potential
  • length of stay on PICU [ Time Frame: 14 days after surgery or discharge of hospital, whatever occurs earlier ] [ Designated as safety issue: No ]
  • Additional transfusion/blood products requirements [ Time Frame: 24 hours after start of surgery ] [ Designated as safety issue: No ]
  • Occurence of re-bleeding, surgical revision [ Time Frame: 14 days after surgery or discharge of hospital, whatever occurs earlier ] [ Designated as safety issue: No ]
  • (S)AE [ Time Frame: 14 days after surgery or discharge of hospital, whatever occurs earlier ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Blood Coagulation Disorders
  • Hemorrhage
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 Name: Haemocomplettan P, CSL Behring
  • Active Comparator: Fibrinogen if FibTEM < 8 mm
    Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 8 mm
    Intervention: Drug: Human fibrinogen concentrate
  • Experimental: Fibrinogen if FibTEM < 13 mm
    Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 13 mm
    Intervention: Drug: Human fibrinogen concentrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
6 Months to 17 Years
No
Contact: Thorsten Haas, MD +41 44 266 ext 8152 thorsten.haas@kispi.uzh.ch
Contact: Markus Schmugge, MD +41 44 266 ext 7182 markus.schmugge@kispi.uzh.ch
Switzerland
 
NCT01487837
KEK-ZH-Nr. 2011-0440
Yes
University Children's Hospital, Zurich
University Children's Hospital, Zurich
Not Provided
Principal Investigator: Thorsten Haas, MD Zurich University Children's Hospital
University Children's Hospital, Zurich
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP