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Leveraging Turbidity and Thromboelastography for Complementary Clot Characterization
Published on: June 4, 2020
Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of
Lucas Siqueira de Lucena1,2, Roseny Dos Reis Rodrigues1, Maria José Carvalho Carmona1
1Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.
Insights
Early fibrinogen concentrate administration in severe trauma patients with hypofibrinogenemia is feasible. This intervention may reduce intensive care unit length of stay, warranting further investigation in larger clinical trials.
Area of Science:
- Trauma care
- Emergency medicine
- Hematology
Background:
- Severe trauma often leads to hypofibrinogenemia, a condition associated with increased mortality.
- Early identification and management of hypofibrinogenemia are crucial in trauma resuscitation.
Purpose of the Study:
- To evaluate the feasibility and clinical effects of early fibrinogen concentrate administration in severe trauma patients with hypofibrinogenemia.
- To assess the impact on transfusion requirements and other clinical outcomes.
Main Methods:
- An open randomized feasibility trial was conducted involving 32 severe trauma patients.
- Patients with hypotension, tachycardia, and hypofibrinogenemia received either fibrinogen concentrate or standard care.
- Feasibility was defined as treatment delivery within 60 minutes of randomization.
Main Results:
- The study achieved 100% feasibility, with all patients receiving allocated treatment within 60 minutes.
- The intervention group showed a significantly shorter intensive care unit (ICU) stay (8 vs. 11 days, p=0.02).
- No significant differences were observed in other clinical outcomes or adverse events.
Conclusions:
- Early fibrinogen replacement using fibrinogen concentrate is a feasible strategy in severe trauma with hypofibrinogenemia.
- While feasibility is demonstrated, larger trials are necessary to confirm clinical benefits and efficacy.
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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Assessment:
1. Clinical Evaluation:
History:

