Clinical trial NCT02864875: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trauma
Bleeding Disorder
Fibrinogen; Deficiency, Acquired
Keywords: Trauma
Coagulopathy
Fibrinogen
Fibrinogen Concentrate
Thromboelastometry
Hypofibrinogenemia
Early Fibrinogen Replacement
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization
timeFrame: 60 minutes
Secondary outcomes:
measure: Overall blood tube drainage
timeFrame: 48 hours
measure: Overall blood tube drainage
timeFrame: Up to four weeks - Through the length of hospital stay
measure: Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
timeFrame: 48 hours
measure: Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
timeFrame: Up to four days - Through the Length of operating room stay
measure: Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
timeFrame: Up to four weeks - Through the Length of intensive care unit stay
measure: Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
timeFrame: Up to four weeks - Through the Length of operating room stay
measure: 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
timeFrame: Up to four weeks - Through the Length of operating room stay
measure: Thromboembolic events assessed by any clinical manifestation that can be related to a thromboembolic event
timeFrame: First two weeks after hospital admission
measure: Reoperate due to bleeding
timeFrame: Up to four weeks - Through the Length of operating room stay
measure: Ventilator-free days
timeFrame: Up to four weeks - Through the Length of operating room stay
measure: Vasopressor-free days
timeFrame: Up to four weeks - Through the Length of operating room stay
measure: Length of hospital stay
timeFrame: Up to four weeks - Through the Length of operating room stay
measure: Length of intensive care unit stay
timeFrame: Up to four weeks - Through the Length of intensive care unit stay
measure: In-hospital Deaths
timeFrame: Up to four weeks - Through the Length of operating room stay
measure: Sequential Organ Failure Assessment (SOFA) score on the first day after intensive care unit admission
timeFrame: First day after intensive care unit admission
measure: Sequential Organ Failure Assessment (SOFA) score on the fifth day after intensive care unit admission
timeFrame: Fifth day after intensive care unit admission
measure: Sequential Organ Failure Assessment (SOFA) score on the seventh day after intensive care unit admission
timeFrame: Seventh day after intensive care unit admission
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas - FMUSP
Study officials:
affiliation: Hospital das Clínicas da FMUSP
name: Lucas S Lucena, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.