A Phase 4 interventional study of Fibrinogen concentrate in Trauma, Bleeding Disorder and Fibrinogen; Deficiency, Acquired, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-01.
Sponsored by University of Sao Paulo General Hospital · Phase 4, Interventional, and Treatment
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.
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.
502 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 32 is below the median of 52 across 252 interventional studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Not to receive an early replacement of fibrinogen
Receive early replacement through fibrinogen concentrate (50mg per kg of body weight)
Drug: Fibrinogen concentrate
Receive fibrinogen concentrate 50mg/kg of body weight after randomization
Also known as: Haemocomplettan®
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
Time frame: 60 minutes
Overall blood tube drainage
Overall blood tube drainage
Time frame: 48 hours
Overall blood tube drainage
Overall blood tube drainage
Time frame: 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
Transfusion requirements
Time frame: 48 hours
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Transfusion requirements
Time frame: 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
Transfusion requirements
Time frame: 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
Transfusion requirements
Time frame: 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
Costs of blood therapy
Time frame: 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
Thromboembolic events
Time frame: First two weeks after hospital admission
Reoperate due to bleeding
Reoperate due to bleeding
Time frame: Up to four weeks - Through the Length of operating room stay
Ventilator-free days
Ventilator-free days
Time frame: Up to four weeks - Through the Length of operating room stay
Vasopressor-free days
Vasopressor-free days
Time frame: Up to four weeks - Through the Length of operating room stay
Length of hospital stay
Length of hospital stay
Time frame: Up to four weeks - Through the Length of operating room stay
Length of intensive care unit stay
Length of intensive care unit stay
Time frame: Up to four weeks - Through the Length of intensive care unit stay
In-hospital Deaths
In-hospital Deaths
Time frame: 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
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
Time frame: First day after intensive care unit admission
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
Time frame: Fifth day after intensive care unit admission
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
Time frame: Seventh day after intensive care unit admission
Plan to share: No
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital