Skip to main content
OpenTrials
Completed

NCT Number: NCT02864875

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Trauma Afibrinogenemia Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Cardiovascular Diseases Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fibrinogen; Deficiency, Acquired Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital das Clínicas - FMUSP

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibrinogen concentrate

Drug

Receive fibrinogen concentrate 50mg/kg of body weight after randomization

Other names: Haemocomplettan®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Aug 12, 2016
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.