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Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial
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 emerge...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Faculdade de Medicina / USP
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8552954/ https://www.ncbi.nlm.nih.gov/pubmed/34755760 http://dx.doi.org/10.6061/clinics/2021/e3168 |
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author | de Lucena, Lucas Siqueira Rodrigues, Roseny dos Reis Carmona, Maria José Carvalho Noronha, Francisco José Diniz Oliveira, Helenode Paiva Lima, Natalia Martins Pinheiro, Rodrigo Brandão da Silva, Wallace Andrino Cavalcanti, Alexandre Biasi |
author_facet | de Lucena, Lucas Siqueira Rodrigues, Roseny dos Reis Carmona, Maria José Carvalho Noronha, Francisco José Diniz Oliveira, Helenode Paiva Lima, Natalia Martins Pinheiro, Rodrigo Brandão da Silva, Wallace Andrino Cavalcanti, Alexandre Biasi |
author_sort | de Lucena, Lucas Siqueira |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8552954 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Faculdade de Medicina / USP |
record_format | MEDLINE/PubMed |
spelling | pubmed-85529542021-10-29 Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial de Lucena, Lucas Siqueira Rodrigues, Roseny dos Reis Carmona, Maria José Carvalho Noronha, Francisco José Diniz Oliveira, Helenode Paiva Lima, Natalia Martins Pinheiro, Rodrigo Brandão da Silva, Wallace Andrino Cavalcanti, Alexandre Biasi Clinics (Sao Paulo) Original Article 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. Faculdade de Medicina / USP 2021-10-28 2021 /pmc/articles/PMC8552954/ /pubmed/34755760 http://dx.doi.org/10.6061/clinics/2021/e3168 Text en Copyright © 2021 CLINICS https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons License (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ) which permits unrestricted use, distribution, and reproduction in any medium or format, provided the original work is properly cited. |
spellingShingle | Original Article de Lucena, Lucas Siqueira Rodrigues, Roseny dos Reis Carmona, Maria José Carvalho Noronha, Francisco José Diniz Oliveira, Helenode Paiva Lima, Natalia Martins Pinheiro, Rodrigo Brandão da Silva, Wallace Andrino Cavalcanti, Alexandre Biasi Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial |
title | Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial |
title_full | Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial |
title_fullStr | Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial |
title_full_unstemmed | Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial |
title_short | Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial |
title_sort | early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: a randomized feasibility trial |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8552954/ https://www.ncbi.nlm.nih.gov/pubmed/34755760 http://dx.doi.org/10.6061/clinics/2021/e3168 |
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