Pre-hospital Administration of Fibrinogen in Trauma-Induced Coagulopathy
NCT Number: NCT06582420
Acronym: PAF-TIC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Trauma Induced Coagulopathy
Interventions: DRUG: Fibrinogen concentrate|DRUG: Standard trauma care
Sponsor: Unidade Local de Saude do Arco Ribeirinho
Collaborators: Unidade Local de Saúde de São José|Unidade Local de Saúde da Arrábida|Unidade Local de Saúde de Santa Maria|Unidade Local de Saúde Almada-Seixal
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2025-12-31

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.

Primary Outcome Measures: 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., First 30 minutes on hospital arrival|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., Prehospital setting
Secondary Outcome Measures: Mortality, Defined as the survival status of the patient regardless of the patient's location (hospital, rehabilitation facility, home)., Day 7 and day 28|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., Up to 90 days|Multiple Organ Failure, Incidence of multiple organ failure. Data on transfusion requirements and complications will be collected., Up to 90 days|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., Day 1|Change of clot stability upon arrival, Change in blood clot stability upon arrival at the emergency room, as measured by maximum clot firmness in the FIBTEM assay (FIBTEM MCF) comparing both arms after administration of., First 30 minutes on hospital arrival|Clot Formation, Clot Formation: Utilize the EXTEM A5 and A10 measured by thromboelastometry as early indicators of clot propagation phase, as they both are both early, sensitive and specific assessments of coagulopathy. Normal Extem A5 ranges from 15 to 25 mm and normal Extem A10 ranges from 22 to 34 mm., Up to 90 days|Clot Stability, Clot Stability: Utilize the maximum clot firmness (MCF) measured by thromboelastometry (e.g., ROTEM® FIBTEM assay) as a quantitative indicator of clot stability. The normal range for MCF in the FIBTEM assay typically spans from 9 to 25 mm, indicating the clot's adequate structural integrity under physiological conditions. A clinically significant improvement in clot stability, as evidenced by an increase in MCF, is defined by a post-intervention measurement that exceeds the upper limit of the baseline (pre-intervention) range by at least 20%, ensuring the change is beyond normal variability and likely to impact clinical outcomes., Up to 90 days|Incidence of Thromboembolic events, Deep Vein Thrombosis (DVT) is defined by clinical symptoms (limb swelling, pain, and/or redness), plus diagnostic confirmation by ultrasound imaging technique (vein incompressibility or direct thrombus visualization). Thrombosis associated to venous manipulation (such as catheter-related thrombosis) is excluded from this analysis.

Clinically significant Pulmonary Embolism (PE) is defined by the presence of hypoxic respiratory failure plus the demonstration of a clot in pulmonary arteries by computed tomographic pulmonary angiography (CTPA). Fat or air embolism will be excluded from this analysis.

Ischemic Stroke diagnosis is defined as the sudden onset of neurological deficits, plus brain ischemia on brain computed tomography (CT) or magnetic resonance imaging (MRI).

Myocardial Infarction (MI) is defined by chest pain, acute and typical changes on the electrocardiogram (ECG), and elevated cardiac biomarkers like troponin., Up to 7 days after hospital admission