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Pre-hospital Administration of Fibrinogen in Trauma-Induced Coagulopathy
Sponsor: Unidade Local de Saude do Arco Ribeirinho
Summary
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.
Official title: Pre-hospital Administration of Fibrinogen Concentrate in Patients With Suspected Trauma-Induced Coagulopathy (PAF-TIC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2025-01-01
Completion Date
2025-12-31
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
Fibrinogen concentrate
Patients 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
Patients 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.