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

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

Sponsors

Lead sponsor: University of Sao Paulo General Hospital

Source 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.

Overall Status Completed
Start Date December 2015
Completion Date July 2018
Primary Completion Date January 2017
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization 60 minutes
Secondary Outcome
Measure Time Frame
Overall blood tube drainage 48 hours
Overall blood tube drainage Up to four weeks - Through the length of hospital stay
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate 48 hours
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate Up to four days - Through the Length of operating room stay
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate Up to four weeks - Through the Length of intensive care unit stay
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
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
Thromboembolic events assessed by any clinical manifestation that can be related to a thromboembolic event First two weeks after hospital admission
Reoperate due to bleeding Up to four weeks - Through the Length of operating room stay
Ventilator-free days Up to four weeks - Through the Length of operating room stay
Vasopressor-free days Up to four weeks - Through the Length of operating room stay
Length of hospital stay Up to four weeks - Through the Length of operating room stay
Length of intensive care unit stay Up to four weeks - Through the Length of intensive care unit stay
In-hospital Deaths Up to four weeks - Through the Length of operating room stay
Sequential Organ Failure Assessment (SOFA) score on the first day after intensive care unit admission First day after intensive care unit admission
Sequential Organ Failure Assessment (SOFA) score on the fifth day after intensive care unit admission Fifth day after intensive care unit admission
Sequential Organ Failure Assessment (SOFA) score on the seventh day after intensive care unit admission Seventh day after intensive care unit admission
Enrollment 32
Condition
Intervention

Intervention type: Drug

Intervention name: Fibrinogen concentrate

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

Arm group label: Intervention

Other name: Haemocomplettan®

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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Lucas S Lucena, MD Principal Investigator Hospital das Clínicas da FMUSP
Location
facility
Hospital das Clínicas - FMUSP
Location Countries

Brazil

Verification Date

July 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Sao Paulo General Hospital

Investigator full name: Lucas Siqueira de Lucema

Investigator title: Lucas Lucena

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Control

Arm group type: No Intervention

Description: Not to receive an early replacement of fibrinogen

Arm group label: Intervention

Arm group type: Experimental

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov