Evaluation of the efficiency under current use of human fibrinogen concentrate in trauma patients with life-threatening hemorrhagic disorders

Abstract

The aim of the study was to assess the influence of fibrinogen concentrate on survival when it is used in trauma patients with life-threatening hemorrhagic disorders. Secondly, to evaluate when the fibrinogen concentrate administration maximizes its efficacy, and to describe what other concomitant treatment the patients received in order to control their life-threatening hemorrhage. Retrospective, observational, and multicenter study was carried out in three trauma areas between June 2012 and June 2014. The totality of trauma patients with a documented life-threatening hemorrhage who received a fibrinogen concentrate prescription was included in the study. Demographic and analytical data, admission diagnosis, treatment indication, fibrinogen concentrate dose, survival after 1 and 7 days, hospitalization time, and concomitant blood product treatment were collected. One hundred and twenty-three patients were finally included. The mean dose of fibrinogen concentrate administered was 2.87 g. The mean initial fibrinogen plasma level was 1.49 g/l, which rose to 2.26 g/l. The number of patients who survived after 24 h was 80.49%, and 69.11% after 7 days. Lower fibrinogen plasma levels are statistically associated with a higher probability of death after 7 days (P = 0.004). The most suitable threshold to recommend the fibrinogen concentrate administration has been found to be 1.5 g/dl (P = 0006, after 24 h; P = 0.032, after 7 days). Finally, the most common concomitant treatment was the erythrocytes concentrate. A statistically significant relationship between lower fibrinogen plasma levels and a higher probability of death after 7 days has been found. Our data support the threshold of 1.5 g/l as the recommended level to administer fibrinogen concentrate in trauma patients.

Efficacy and safety of the drugs used to reverse direct oral anticoagulants: a systematic review and meta‐analysis

“…Moreover, the use of activated oral charcoal (within 2 hr) in patients who recently ingested DOACs is recommended by some authors . For cases in which supportive care and drug discontinuation are not sufficient, if immediate reversal is required and the patient is having life‐threatening bleeding, nonspecific procoagulant or antifibrinolytic agents can be added to PCCs, such as fresh‐frozen plasma (FFP), fibrinogen concentrate or cryoprecipitate, and tranexamic acid . Hemodialysis for dabigatran removal may also be used.…”

Transfusion Approaches and Mortality in Trauma Patients: A Narrative Review

“…45 The results of Gonzalez-Guerrero et al support the possibility that raising patients' plasma fibrinogen levels may, potentially, decrease mortality rates. 42 Moreover, the results of studies comparing guided treatment with coagulation factor concentrates (principally FC) versus treatment based on FFP have reported reduced transfusion and lower rates of MOF with coagulation factor concentrates. 16,18 The study by Innerhofer et al was stopped early for futility and safety reasons, with a much increased need for rescue therapy in patients receiving FFP rather than coagulation factor concentrates (odds ratio [OR]: 25.34).…”

“…Other studies of nonguided treatment with allogeneic blood products did not employ a ratio-based approach. 12,[26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] These studies varied in outcomes and treatment approach, with mortality and ISS varying widely (ISS: 16.8-42.5). The highest mortality rates were observed in critically ill patients receiving ultramassive (defined as transfusion of 20 U RBC over the course of any 2 consecutive calendar days) or massive transfusions (mortality rates of 63% at 30 days and 58.5% while in hospital, respectively), 27,41 patients with coagulopathies (30day mortality: 50%), 32 and patients with a greater degrees of hemodynamic instability (group with highest Shock Index stratification had mortality rate of 39.8%).…”

“…44 A retrospective study of patients who received FC without guided treatment being specified showed that low plasma fibrinogen levels were associated with increased mortality, and that the mortality rate was decreased in patients achieving a plasma fibrinogen level of 2.5 g/L. 42 A comparison of patients receiving FC between the emergency department and intensive care unit (ICU) or not receiving FC found that FC patients had a reduced 6-hour mortality rate, but there was no difference in overall mortality (27.9 vs. 24.8%, respectively). 45 However, the study noted significantly higher rates of MOF in FC patients, suggesting that FC treatment may have prevented early deaths from hemorrhage.…”

Hemostatic agents for prehospital hemorrhage control: a narrative review

“…Several retrospective studies and case series have reported improved outcomes using FC in trauma [62,87]. There have been some debates about its clinical benefits [88,89] and its use as a universal hemostatic agent [90].…”