Trauma, Bleeding Disorder, Fibrinogen; Deficiency, Acquired
Conditions
Keywords
Trauma, Coagulopathy, Fibrinogen, Fibrinogen Concentrate, Thromboelastometry, Hypofibrinogenemia, Early Fibrinogen Replacement
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.
Interventions
Receive fibrinogen concentrate 50mg/kg of body weight after randomization
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate | 48 hours | Transfusion requirements |
| 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 |
| Thromboembolic events assessed by any clinical manifestation that can be related to a thromboembolic event | First two weeks after hospital admission | Thromboembolic events |
| 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 |
| Overall blood tube drainage | 48 hours | Overall blood tube drainage |
| 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 |
| 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 |
| Length of hospital stay | Up to four weeks - Through the Length of operating room stay | Length of hospital stay |
Countries
Brazil
Outcome results
None listed