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

Lucas Siqueira de Lucena, Roseny Dos Reis Rodrigues, Maria José Carvalho Carmona, Francisco José Diniz Noronha, Heleno de Paiva Oliveira, Natalia Martins Lima, Rodrigo Brandão Pinheiro, Wallace Andrino da Silva, Alexandre Biasi Cavalcanti, Lucas Siqueira de Lucena, Roseny Dos Reis Rodrigues, Maria José Carvalho Carmona, Francisco José Diniz Noronha, Heleno de Paiva Oliveira, Natalia Martins Lima, Rodrigo Brandão Pinheiro, Wallace Andrino da Silva, Alexandre Biasi Cavalcanti

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.

Conflict of interest statement

Conflicts of Interest. Roseny Rodrigues gives lectures to CSL Behring regarding coagulation and hemostatic drugs. The other authors declare that they have no competing interests.

Figures

Figure 1. Patient flow in the study.…
Figure 1. Patient flow in the study. Source: CONSORT, 2010.

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