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

Primary Purpose

Trauma, Bleeding Disorder, Fibrinogen; Deficiency, Acquired

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Fibrinogen concentrate
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring Trauma, Coagulopathy, Fibrinogen, Fibrinogen Concentrate, Thromboelastometry, Hypofibrinogenemia, Early Fibrinogen Replacement

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clínicas - FMUSP

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Not to receive an early replacement of fibrinogen

Receive early replacement through fibrinogen concentrate (50mg per kg of body weight)

Outcomes

Primary Outcome Measures

Feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization
The proportion of patients receiving the allocated treatment up to 60 minutes after randomization

Secondary Outcome Measures

Overall blood tube drainage
Overall blood tube drainage
Overall blood tube drainage
Overall blood tube drainage
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Transfusion requirements
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Transfusion requirements
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Transfusion requirements
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Transfusion requirements
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
Costs of blood therapy
Thromboembolic events assessed by any clinical manifestation that can be related to a thromboembolic event
Thromboembolic events
Reoperate due to bleeding
Reoperate due to bleeding
Ventilator-free days
Ventilator-free days
Vasopressor-free days
Vasopressor-free days
Length of hospital stay
Length of hospital stay
Length of intensive care unit stay
Length of intensive care unit stay
In-hospital Deaths
In-hospital Deaths
Sequential Organ Failure Assessment (SOFA) score on the 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
Sequential Organ Failure Assessment (SOFA) score on the 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
Sequential Organ Failure Assessment (SOFA) score on the 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

Full Information

First Posted
August 9, 2016
Last Updated
July 31, 2018
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02864875
Brief Title
Early Administration of Fibrinogen in Polytraumatized Patients With Hypofibrinogenemia: a Randomized Feasibility Trial
Official Title
Early Administration of Fibrinogen Concentrate in Polytraumatized Patients With Thromboelastometry Suggestive of Hypofibrinogenemia: a Randomized Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Bleeding Disorder, Fibrinogen; Deficiency, Acquired
Keywords
Trauma, Coagulopathy, Fibrinogen, Fibrinogen Concentrate, Thromboelastometry, Hypofibrinogenemia, Early Fibrinogen Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Not to receive an early replacement of fibrinogen
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Receive early replacement through fibrinogen concentrate (50mg per kg of body weight)
Intervention Type
Drug
Intervention Name(s)
Fibrinogen concentrate
Other Intervention Name(s)
Haemocomplettan®
Intervention Description
Receive fibrinogen concentrate 50mg/kg of body weight after randomization
Primary Outcome Measure Information:
Title
Feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization
Description
The proportion of patients receiving the allocated treatment up to 60 minutes after randomization
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Overall blood tube drainage
Description
Overall blood tube drainage
Time Frame
48 hours
Title
Overall blood tube drainage
Description
Overall blood tube drainage
Time Frame
Up to four weeks - Through the length of hospital stay
Title
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Description
Transfusion requirements
Time Frame
48 hours
Title
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Description
Transfusion requirements
Time Frame
Up to four days - Through the Length of operating room stay
Title
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Description
Transfusion requirements
Time Frame
Up to four weeks - Through the Length of intensive care unit stay
Title
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Description
Transfusion requirements
Time Frame
Up to four weeks - Through the Length of operating room stay
Title
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
Description
Costs of blood therapy
Time Frame
Up to four weeks - Through the Length of operating room stay
Title
Thromboembolic events assessed by any clinical manifestation that can be related to a thromboembolic event
Description
Thromboembolic events
Time Frame
First two weeks after hospital admission
Title
Reoperate due to bleeding
Description
Reoperate due to bleeding
Time Frame
Up to four weeks - Through the Length of operating room stay
Title
Ventilator-free days
Description
Ventilator-free days
Time Frame
Up to four weeks - Through the Length of operating room stay
Title
Vasopressor-free days
Description
Vasopressor-free days
Time Frame
Up to four weeks - Through the Length of operating room stay
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
Up to four weeks - Through the Length of operating room stay
Title
Length of intensive care unit stay
Description
Length of intensive care unit stay
Time Frame
Up to four weeks - Through the Length of intensive care unit stay
Title
In-hospital Deaths
Description
In-hospital Deaths
Time Frame
Up to four weeks - Through the Length of operating room stay
Title
Sequential Organ Failure Assessment (SOFA) score on the first day after intensive care unit admission
Description
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
Time Frame
First day after intensive care unit admission
Title
Sequential Organ Failure Assessment (SOFA) score on the fifth day after intensive care unit admission
Description
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
Time Frame
Fifth day after intensive care unit admission
Title
Sequential Organ Failure Assessment (SOFA) score on the seventh day after intensive care unit admission
Description
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
Time Frame
Seventh day after intensive care unit admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas S Lucena, MD
Organizational Affiliation
Hospital das Clínicas da FMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas - FMUSP
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34755760
Citation
Lucena LS, Rodrigues RDR, Carmona MJC, Noronha FJD, Oliveira HP, Lima NM, Pinheiro RB, Silva WAD, Cavalcanti AB. Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial. Clinics (Sao Paulo). 2021 Nov 8;76:e3168. doi: 10.6061/clinics/2021/e3168. eCollection 2021.
Results Reference
derived

Learn more about this trial

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

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