Trial reportClinics (Sao Paulo, Brazil)2021
Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial.
Trial report in Clinics (Sao Paulo, Brazil), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Early Administration of Fibrinogen Concentrate in Polytraumatized Patients With Thromboelastometry Suggestive of Hypofibrinogenemia: a Randomized Feasibility Trial
Pre-hospital Administration of Fibrinogen Concentrate in Patients With Suspected Trauma-Induced Coagulopathy (PAF-TIC)
Who cites it
9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 11 citations in OpenAlex.
- THE EFFICACY OF COAGULATION FACTOR CONCENTRATES IN THE MANAGEMENT OF PATIENTS WITH TRAUMA-INDUCED COAGULOPATHY: A SYSTEMATIC REVIEW AND META-ANALYSIS.Shock (Augusta, Ga.) · 2025Pooled it
- Emergency administration of fibrinogen concentrate for haemorrhage: systematic review and meta-analysis.World journal of emergency surgery : WJES · 2023Pooled it
- The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition.Critical care (London, England) · 2023Guideline
- Article
- Recommendations for implementing patient blood management-an updated modified Delphi consensus from a multidisciplinary expert panel in Hong Kong.Journal of anesthesia, analgesia and critical care · 2026Review
- Hemostatic resuscitation in patients with trauma-induced coagulopathy: a narrative review.Acute and critical care · 2026Article
- Treatments for Trauma-Induced Coagulopathy: Protocol for a Systematic Review and Meta-Analysis.JMIR research protocols · 2023Article
- Coagulopathy management of multiple injured patients - a comprehensive literature review of the European guideline 2019.EFORT open reviews · 2022Review
- Long-Term Safety Analysis of a Fibrinogen Concentrate (RiaSTAPClinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the clinical effects of early administration of fibrinogen concentrate in patients with severe trauma and hypofibrinogenemia.
methodsWe 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.
resultsThirty-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.
conclusionEarly fibrinogen replacement with fibrinogen concentrate was feasible. Larger trials are required to properly evaluate clinical outcomes.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.