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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02864875
Other study ID # 662.182
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2015
Est. completion date July 2018

Study information

Verified date July 2018
Source University of Sao Paulo General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date July 2018
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Brazil Hospital das Clínicas - FMUSP São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 60 minutes
Secondary Overall blood tube drainage Overall blood tube drainage 48 hours
Secondary Overall blood tube drainage Overall blood tube drainage Up to four weeks - Through the length of hospital stay
Secondary Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate Transfusion requirements 48 hours
Secondary Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate Transfusion requirements Up to four days - Through the Length of operating room stay
Secondary Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate Transfusion requirements Up to four weeks - Through the Length of intensive care unit stay
Secondary Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate Transfusion requirements Up to four weeks - Through the Length of operating room stay
Secondary 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 Up to four weeks - Through the Length of operating room stay
Secondary Thromboembolic events assessed by any clinical manifestation that can be related to a thromboembolic event Thromboembolic events First two weeks after hospital admission
Secondary Reoperate due to bleeding Reoperate due to bleeding Up to four weeks - Through the Length of operating room stay
Secondary Ventilator-free days Ventilator-free days Up to four weeks - Through the Length of operating room stay
Secondary Vasopressor-free days Vasopressor-free days Up to four weeks - Through the Length of operating room stay
Secondary Length of hospital stay Length of hospital stay Up to four weeks - Through the Length of operating room stay
Secondary Length of intensive care unit stay Length of intensive care unit stay Up to four weeks - Through the Length of intensive care unit stay
Secondary In-hospital Deaths In-hospital Deaths Up to four weeks - Through the Length of operating room stay
Secondary 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
First day after intensive care unit admission
Secondary 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
Fifth day after intensive care unit admission
Secondary 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
Seventh day after intensive care unit admission
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