Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01487837
First received: December 5, 2011
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Blood Coagulation Disorders
Hemorrhage
Drug: Human fibrinogen concentrate
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • Total amount of transfused red cell concentrate [ Time Frame: 24 hours after start of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 57
Study Start Date: January 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Haemocomplettan P, CSL Behring

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487837

Locations
Switzerland
Zurich University Children's Hospital
Zurich, Switzerland, 8032
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Principal Investigator: Thorsten Haas, MD Zurich University Children's Hospital
  More Information

No publications provided

Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT01487837     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2011-0440
Study First Received: December 5, 2011
Last Updated: October 24, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University Children's Hospital, Zurich:
Fibrinogen
Blood coagulation disorders
Postoperative bleeding
Transfusions

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemorrhage
Hemostatic Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014