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Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.

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ClinicalTrials.gov Identifier: NCT01487837
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich

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.

Condition or disease Intervention/treatment Phase
Blood Coagulation Disorders Hemorrhage Drug: Human fibrinogen concentrate Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : January 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. Total amount of transfused red cell concentrate [ Time Frame: 24 hours after start of surgery ]

Secondary Outcome Measures :
  1. 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

  2. length of stay on PICU [ Time Frame: 14 days after surgery or discharge of hospital, whatever occurs earlier ]
  3. Additional transfusion/blood products requirements [ Time Frame: 24 hours after start of surgery ]
  4. Occurence of re-bleeding, surgical revision [ Time Frame: 14 days after surgery or discharge of hospital, whatever occurs earlier ]
  5. Occurence of (severe) adverse events [ Time Frame: 14 days after surgery or discharge of hospital, whatever occurs earlier ]


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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT01487837     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2011-0440
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014

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

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