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Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial
Lucena, Lucas Siqueira de; Rodrigues, Roseny dos Reis; Carmona, Maria José Carvalho; Noronha, Francisco José Diniz; Oliveira, Heleno de Paiva; Lima, Natalia Martins; Pinheiro, Rodrigo Brandão; Silva, Wallace Andrino da; Cavalcanti, Alexandre Biasi.
  • Lucena, Lucas Siqueira de; Universidade de Sao Paulo. Faculdade de Medicina FMUSP. Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria. Sao Paulo. BR
  • Rodrigues, Roseny dos Reis; Universidade de Sao Paulo. Faculdade de Medicina FMUSP. Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria. Sao Paulo. BR
  • Carmona, Maria José Carvalho; Universidade de Sao Paulo. Faculdade de Medicina FMUSP. Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria. Sao Paulo. BR
  • Noronha, Francisco José Diniz; Universidade de Sao Paulo. Faculdade de Medicina FMUSP. Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria. Sao Paulo. BR
  • Oliveira, Heleno de Paiva; Universidade de Sao Paulo. Faculdade de Medicina FMUSP. Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria. Sao Paulo. BR
  • Lima, Natalia Martins; Universidade de Sao Paulo. Faculdade de Medicina FMUSP. Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria. Sao Paulo. BR
  • Pinheiro, Rodrigo Brandão; Universidade de Sao Paulo. Faculdade de Medicina FMUSP. Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria. Sao Paulo. BR
  • Silva, Wallace Andrino da; Universidade de Sao Paulo. Faculdade de Medicina FMUSP. Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria. Sao Paulo. BR
  • Cavalcanti, Alexandre Biasi; Universidade de Sao Paulo. Faculdade de Medicina FMUSP. Programa de Pos-graduacao em Anestesiologia, Ciencias Cirurgicas e Medicina Perioperatoria. Sao Paulo. BR
Clinics ; 76: e3168, 2021. tab, graf
Article in English | LILACS | ID: biblio-1345815
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.
Subject(s)


Full text: Available Index: LILACS (Americas) Main subject: Fibrinogen / Multiple Trauma / Afibrinogenemia Type of study: Controlled clinical trial Limits: Humans Language: English Journal: Clinics Journal subject: Medicine Year: 2021 Type: Article Affiliation country: Brazil Institution/Affiliation country: Universidade de Sao Paulo/BR

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Full text: Available Index: LILACS (Americas) Main subject: Fibrinogen / Multiple Trauma / Afibrinogenemia Type of study: Controlled clinical trial Limits: Humans Language: English Journal: Clinics Journal subject: Medicine Year: 2021 Type: Article Affiliation country: Brazil Institution/Affiliation country: Universidade de Sao Paulo/BR