A prospective, randomized controlled trial of fibrinogen concentrate (FC) plus standard of care versus standard of care alone in adult trauma patients with major bleeding or presumed major bleeding is developed to evaluate the efficacy and safety of prehospital administration of FC in trauma patients with suspected hypofibrinogenemia and active bleeding or presumed to be bleeding.
The main endpoints are:
1. Plasma fibrinogen levels in the first blood sample drawn at the patient's arrival at the trauma room and/or similar emergency bay dedicated to trauma and reanimation above the critical threshold of 2.0 g/l. As fibrinogen decreases early in trauma, its deficiency predicts massive bleeding and death. 2. Administration feasibility of FC within the prehospital setting.
Patients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of FC.
None
Known adverse reactions to fibrinogen concentrate (FC)
Isolated trauma such as traumatic head injury only
Need for cardiopulmonary resuscitation (CPR) on the scene or peri-arrest scenarios
Deep hypothermia
Parallel
Fibrinogen concentrate
DrugPatients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of FC. The standard of care is determined by national guidelines on trauma, elaborated by the National Institute of Medical Emergency and taught to prehospital physicians and nurses at the time of enrollment in prehospital teams to ensure consistency in the treatment of trauma patients nationwide. The patients assigned to the intervention arm will receive the administration of a fixed dose of 4g fibrinogen, as per previous studies.
Standard trauma care
DrugPatients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of FC. The standard of care is determined by national guidelines on trauma, elaborated by the National Institute of Medical Emergency and taught to prehospital physicians and nurses at the time of enrollment in prehospital teams to ensure consistency in the treatment of trauma patients nationwide. The patients assigned to the intervention arm will receive the administration of a fixed dose of 4g fibrinogen, as per previous studies.
Plasma fibrinogen levels
Plasma fibrinogen levels in the first blood sample drawn at the patient's arrival at the trauma room and/or similar emergency bay dedicated to trauma and reanimation above the critical threshold of 2.0 g/l. As fibrinogen decreases early in trauma, its deficiency predicts massive bleeding and death.
Administration feasibility
Proportion of Patients Successfully Administered Fibrinogen Concentrate within 60 Minutes Post-Injury. This assessment aims to measure the proportion of eligible trauma patients who receive fibrinogen concentrate (FC) within 60 minutes of their injury. Feasibility will be determined by rigorously evaluating the time it takes to administer the treatment, adherence to the protocol, and any operational challenges encountered. Data will be meticulously compiled to calculate the average time it takes to administer the treatment, the rate of successful protocol adherence, and to identify common barriers to timely FC administration.
Mortality
Defined as the survival status of the patient regardless of the patient's location (hospital, rehabilitation facility, home).
ICU Length of Stay
The total number of days spent in the Intensive Care Unit (ICU) from the time of admission to the time of transfer out of the ICU.
Multiple Organ Failure
Incidence of multiple organ failure. Data on transfusion requirements and complications will be collected.
Change of fibrinogen levels
Change of serum fibrinogen concentration after administration of FC, by measuring serum fibrinogen levels in the blood sample obtained on scene and the fibrinogen levels in the blood sample obtained in the emergency department.
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Unidade Local de Saude do Arco Ribeirinho
Lead sponsor
Unidade Local de Saúde de São José
Collaborator
Unidade Local de Saúde da Arrábida
Collaborator
Unidade Local de Saúde Santa Maria
Collaborator
Unidade Local de Saúde Almada-Seixal
Collaborator
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