Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial

Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR. Departamento de Anestesiologia, Hospital Universitario Walter Cantidio, Fortaleza, CE, BR. Departamento de Anestesiologia, Hospital Universitario Onofre Lopes, Natal, RN, BR. Instituto de Pesquisa Hcor, Sao Paulo, SP, BR.

Clinics (Sao Paulo, Brazil). 2021;76:e3168
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Abstract
OBJECTIVE To evaluate the clinical effects of early administration of fibrinogen concentrate in patients with severe trauma and hypofibrinogenemia. METHODS We conducted an open randomized feasibility trial between December 2015 and January 2017 in patients with severe trauma admitted to the emergency department of a large trauma center. Patients presented with hypotension, tachycardia, and FIBTEM findings suggestive of hypofibrinogenemia. The intervention group received fibrinogen concentrate (50 mg/kg), and the control group did not receive early fibrinogen replacement. The primary outcome was feasibility assessed as the proportion of patients receiving the allocated treatment within 60 min after randomization. The secondary outcomes were transfusion requirements and other exploratory outcomes. Randomization was performed using sequentially numbered and sealed opaque envelopes. ClinicalTrials.gov: NCT02864875. RESULTS Thirty-two patients were randomized (16 in each group). All patients received the allocated treatment within 60 min after randomization (100%, 95% confidence interval, 86.7%-100%). The median length of intensive care unit stay was shorter in the intervention group (8 days, interquartile range [IQR] 5.75-10.0 vs. 11 days, IQR 8.5-16.0; p=0.02). There was no difference between the groups in other clinical outcomes. No adverse effects related to treatment were recorded in either group. CONCLUSION Early fibrinogen replacement with fibrinogen concentrate was feasible. Larger trials are required to properly evaluate clinical outcomes.
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Language : eng
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