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Early Administration of Fibrinogen in Polytraumatized Patients With Hypofibrinogenemia: a Randomized Feasibility Trial

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ClinicalTrials.gov Identifier: NCT02864875
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Lucas Siqueira de Lucema, University of Sao Paulo General Hospital

Brief Summary:
This is a randomized feasibility trial conducted with severe trauma patients. At admission patients presented hypofibrinogenemia, hypotension and tachycardia. The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization. The treatments regards to receive or not to receive an early replacement of fibrinogen.

Condition or disease Intervention/treatment Phase
Trauma Bleeding Disorder Fibrinogen; Deficiency, Acquired Drug: Fibrinogen concentrate Phase 4

Detailed Description:
This is a randomized feasibility trial conducted between December 2015 and January 2017 with severe trauma patients (Index of Shock Severity [ISS] ≥ 15) admitted to the emergency room of a large trauma center. At admission patients presented qualitative hypofibrinogenemia (FIBTEM A5 ≤ 9 mm), hypotension (systolic blood pressure <90 mmHg) and tachycardia (heart rate > 100 bpm). The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization meaning receive replacement through fibrinogen concentrate (50mg per kg of body weight) by the intervention group and not to receive an early replacement of fibrinogen by control group.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Administration of Fibrinogen Concentrate in Polytraumatized Patients With Thromboelastometry Suggestive of Hypofibrinogenemia: a Randomized Feasibility Trial
Actual Study Start Date : December 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

Arm Intervention/treatment
No Intervention: Control
Not to receive an early replacement of fibrinogen
Experimental: Intervention
Receive early replacement through fibrinogen concentrate (50mg per kg of body weight)
Drug: Fibrinogen concentrate
Receive fibrinogen concentrate 50mg/kg of body weight after randomization
Other Name: Haemocomplettan®




Primary Outcome Measures :
  1. Feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization [ Time Frame: 60 minutes ]
    The proportion of patients receiving the allocated treatment up to 60 minutes after randomization


Secondary Outcome Measures :
  1. Overall blood tube drainage [ Time Frame: 48 hours ]
    Overall blood tube drainage

  2. Overall blood tube drainage [ Time Frame: Up to four weeks - Through the length of hospital stay ]
    Overall blood tube drainage

  3. Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate [ Time Frame: 48 hours ]
    Transfusion requirements

  4. Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate [ Time Frame: Up to four days - Through the Length of operating room stay ]
    Transfusion requirements

  5. Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate [ Time Frame: Up to four weeks - Through the Length of intensive care unit stay ]
    Transfusion requirements

  6. Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate [ Time Frame: Up to four weeks - Through the Length of operating room stay ]
    Transfusion requirements

  7. Costs of blood therapy assessed by de median value spent on each patient due to red blood cell, fresh frozen plasma, blood platelets, cryoprecipitate and fibrinogen concentrate [ Time Frame: Up to four weeks - Through the Length of operating room stay ]
    Costs of blood therapy

  8. Thromboembolic events assessed by any clinical manifestation that can be related to a thromboembolic event [ Time Frame: First two weeks after hospital admission ]
    Thromboembolic events

  9. Reoperate due to bleeding [ Time Frame: Up to four weeks - Through the Length of operating room stay ]
    Reoperate due to bleeding

  10. Ventilator-free days [ Time Frame: Up to four weeks - Through the Length of operating room stay ]
    Ventilator-free days

  11. Vasopressor-free days [ Time Frame: Up to four weeks - Through the Length of operating room stay ]
    Vasopressor-free days

  12. Length of hospital stay [ Time Frame: Up to four weeks - Through the Length of operating room stay ]
    Length of hospital stay

  13. Length of intensive care unit stay [ Time Frame: Up to four weeks - Through the Length of intensive care unit stay ]
    Length of intensive care unit stay

  14. In-hospital Deaths [ Time Frame: Up to four weeks - Through the Length of operating room stay ]
    In-hospital Deaths

  15. Sequential Organ Failure Assessment (SOFA) score on the first day after intensive care unit admission [ Time Frame: First day after intensive care unit admission ]

    The Sequential Organ Failure Assessment (SOFA) score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems.

    The SOFA score can be used to determine the level of organ dysfunction and the mortality risk in ICU patients.

    High values means worst outcomes


  16. Sequential Organ Failure Assessment (SOFA) score on the fifth day after intensive care unit admission [ Time Frame: Fifth day after intensive care unit admission ]

    The Sequential Organ Failure Assessment (SOFA) score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems.

    The SOFA score can be used to determine the level of organ dysfunction and the mortality risk in ICU patients.

    High values means worst outcomes


  17. Sequential Organ Failure Assessment (SOFA) score on the seventh day after intensive care unit admission [ Time Frame: Seventh day after intensive care unit admission ]

    The Sequential Organ Failure Assessment (SOFA) score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems.

    The SOFA score can be used to determine the level of organ dysfunction and the mortality risk in ICU patients.

    High values means worst outcomes




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 80 years
  • Severe trauma patients (Index of Shock Severity [ISS] ≥ 15)
  • Hypotension (systolic blood pressure < 90 mmHg)
  • Tachycardia (heart rate > 100 bpm)
  • Qualitative hypofibrinogenemia (FIBTEM A5 ≤ 9 mm)

Exclusion Criteria:

  • Patient or family do not agree to sign the informed consent form
  • Eligible for institutional massive transfusion protocol
  • Pregnant
  • Previous coagulopathy disorders
  • Use of anticoagulants drugs and/or platelet anti aggregation drugs (exception for aspirin)
  • Previous thromboembolic disorders or events
  • Cardiopulmonary arrest before hospital admission
  • Patient admitted after another hospital transfer
  • Time from trauma to screening above six hours
  • Patients with exclusively traumatic brain injury

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): NCT02864875


Locations
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Brazil
Hospital das Clínicas - FMUSP
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Lucas S Lucena, MD Hospital das Clínicas da FMUSP

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Responsible Party: Lucas Siqueira de Lucema, Lucas Lucena, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02864875     History of Changes
Other Study ID Numbers: 662.182
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lucas Siqueira de Lucema, University of Sao Paulo General Hospital:
Trauma
Coagulopathy
Fibrinogen
Fibrinogen Concentrate
Thromboelastometry
Hypofibrinogenemia
Early Fibrinogen Replacement
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders