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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864875
• Other study ID #: 662.182
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Bleeding Disorder
• Blood Coagulation Disorders
• Fibrinogen; Deficiency, Acquired
• Hemostatic Disorders
• Trauma

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