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

Phase 4

Completed

• Conditions: Fibrinogen; Deficiency, Acquired; Trauma; Bleeding Disorder
• Interventions: Drug: Fibrinogen concentrate

• Registration Number: NCT02864875
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-12
• Primary Completion: 2017-01
• Status Verified: 2018-07
• Study Completion: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Fibrinogen concentrate	Receive early replacement through fibrinogen concentrate (50mg per kg of body weight)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Up to four weeks - Through the Length of operating room stay	Costs of blood therapy
Overall blood tube drainage	Up to four weeks - Through the length of hospital stay	Overall blood tube drainage
Length of hospital stay	Up to four weeks - Through the Length of operating room stay	Length of hospital stay
Sequential Organ Failure Assessment (SOFA) score on the first day after intensive care unit admission	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	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	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
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate	Up to four weeks - Through the Length of operating room stay	Transfusion requirements
Thromboembolic events assessed by any clinical manifestation that can be related to a thromboembolic event	First two weeks after hospital admission	Thromboembolic events
Length of intensive care unit stay	Up to four weeks - Through the Length of intensive care unit stay	Length of intensive care unit stay
In-hospital Deaths	Up to four weeks - Through the Length of operating room stay	In-hospital Deaths
Reoperate due to bleeding	Up to four weeks - Through the Length of operating room stay	Reoperate due to bleeding
Ventilator-free days	Up to four weeks - Through the Length of operating room stay	Ventilator-free days
Vasopressor-free days	Up to four weeks - Through the Length of operating room stay	Vasopressor-free days

Trial Locations

Locations (1)

Hospital das Clínicas - FMUSP; 🇧🇷 São Paulo, Brazil