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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] ā„ 15) admitted to the emergency room of a large trauma center. At admission patients presented qualitative hypofibrinogenemia (FIBTEM A5 ā¤ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Not to receive an early replacement of fibrinogen | |
| Intervention | Experimental | Receive early replacement through fibrinogen concentrate (50mg per kg of body weight) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrinogen concentrate | Drug | Receive fibrinogen concentrate 50mg/kg of body weight after randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Overall blood tube drainage | Overall blood tube drainage | 48 hours |
| Overall blood tube drainage | Overall blood tube drainage | Up to four weeks - Through the length of hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucas S Lucena, MD | Hospital das ClĆnicas da FMUSP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClĆnicas - FMUSP | SĆ£o Paulo | 05403-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34755760 | Derived | 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. |
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| Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate | Transfusion requirements | 48 hours |
| Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate | Transfusion requirements | 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 | 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 | 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 | 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 | First two weeks after hospital admission |
| Reoperate due to bleeding | Reoperate due to bleeding | Up to four weeks - Through the Length of operating room stay |
| Ventilator-free days | Ventilator-free days | Up to four weeks - Through the Length of operating room stay |
| Vasopressor-free days | Vasopressor-free days | Up to four weeks - Through the Length of operating room stay |
| Length of hospital stay | Length of hospital stay | Up to four weeks - Through the Length of operating room stay |
| Length of intensive care unit stay | Length of intensive care unit stay | Up to four weeks - Through the Length of intensive care unit stay |
| In-hospital Deaths | 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 | 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 | 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 | 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 | Seventh day after intensive care unit admission |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D020141 | Hemostatic Disorders |
| D000347 | Afibrinogenemia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D020147 | Coagulation Protein Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D005340 | Fibrinogen |
| ID | Term |
|---|---|
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001779 | Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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