scholarly journals Effect of a fixed-ratio (1:1:1) transfusion protocol versus laboratory-results-guided transfusion in patients with severe trauma: a randomized feasibility trial

2013 ◽  
Vol 185 (12) ◽  
pp. E583-E589 ◽  
Author(s):  
B. Nascimento ◽  
J. Callum ◽  
H. Tien ◽  
G. Rubenfeld ◽  
R. Pinto ◽  
...  
2013 ◽  
Vol 4 (3S) ◽  
pp. 17-29
Author(s):  
Klaus Görlinger

In recent years there have been major advances in the management of trauma-induced coagulopathy (TIC) and many experiences have demonstrated how we can achieve significant improvements with multidisciplinary approach and implementation of standardized protocols and algorithms. Central nervous system injuries and exanguination remain the primary causes of early trauma-related mortality. Traumatic brain injuries (TBI) make hemostasis in TIC even more complex and it is known that the onset of coagulopathy in a patient with severe brain injury has a negative impact on the patient’s outcome in terms of mortality. Standard coagulation tests provide limited information on coagulation disorder. The advantages of whole-blood viscoelastic tests, such as rotational thromboelastometry or thrombelastography, are shorter turn-around time and better diagnostic performance compared to routine plasmatic coagulation tests. In contrast to a fixed ratio of FFP:PC:RBC, the aim of the goal-directed coagulation therapy is to set treatment to the actual needs of the individual patient, based on viscoelastic test results. This article describes the improvements achieved through the implementation of ROTEM-guided treatment algorithms for visceral surgery and liver trasplantation, severe trauma and post-partum hemorrhage and cardiovascular surgery.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Pierre Bouzat ◽  
Jean-Luc Bosson ◽  
Jean-Stéphane David ◽  
Bruno Riou ◽  
Jacques Duranteau ◽  
...  

Abstract Background Optimal management of severe trauma patients with active hemorrhage relies on adequate initial resuscitation. Early administration of coagulation factors improves post-traumatic coagulation disorders, and four-factor prothrombin complex concentrate (PCC) might be useful in this context. Our main hypothesis is that four-factor PCC in addition to a massive transfusion protocol decreases blood product consumption at day 1 in severe trauma patients with major bleeding. Methods This is a prospective, randomized, multicenter, double-blind, parallel, controlled superiority trial. Eligible patients are trauma patients with major bleeding admitted to a French level-I trauma center. Patients randomized in the treatment arm receive 1 mL/kg (25 IU/ml of Factor IX/Kg) four-factor PCC within 1-h post-admission while patients randomized in the controlled group receive 1 mL/kg of saline solution 0.9% as a placebo. Treatments are given as soon as possible using syringe pumps (120 mL/h). The primary endpoint is the amount of blood products transfused in the first 24 h post-admission (including red blood cells, frozen fresh plasma, and platelets). The secondary endpoints are the amount of each blood product transfused in the first 24 h, time to achieve prothrombin time ratio < 1.5, time to hemostasis, number of thrombo-embolic events at 28 days, mortality at 24 h and 28 days, number of intensive care unit-free days, number of ventilator-free days, number of hospital-free days within the first 28 days, hospitalization status at day 28, Glasgow outcome scale extended for patients with brain lesions on initial cerebral imaging, and cost of each strategy at days 8 and 28. Inclusions have started in December 2017 and are expected to be complete by June 2021. Discussion If PCC reduces total blood consumption at day 1 after severe trauma, this therapy, in adjunction to a classic massive transfusion protocol, may be used empirically on admission in patients at risk of massive transfusion to enhance coagulation. Moreover, this treatment may decrease blood product-related complications and may improve clinical outcomes after post-traumatic hemorrhage. Trial registration ClinicalTrials.gov NCT03218722. Registered on July 14, 2017


2021 ◽  
Author(s):  
Pierre Bouzat ◽  
Jean-Luc Bosson ◽  
Jean-Stéphane David ◽  
Bruno Riou ◽  
Jacques Duranteau ◽  
...  

Abstract Background: Optimal management of severe trauma patients with active hemorrhage relies on adequate initial resuscitation. Early administration of coagulation factors improves post-traumatic coagulation disorders and four-factor prothrombin complex concentrate (PCC) might be useful in this context. Our main hypothesis is that four-factor PCC in addition to a massive transfusion protocol decrease blood product consumption at day one in severe trauma patients with major bleeding.Methods This is a prospective, randomized, multicenter, double-blind, parallel, controlled superiority trial. Eligible patients are trauma patients with major bleeding admitted to a French level-I trauma centre. Patients randomized in the treatment arm receive 1 mL/kg four-factor PCC within one-hour post-admission while patients randomized in the controlled group receive 1 mL/kg of saline solution 0.9% as a placebo. The primary endpoint is the amount of blood products transfused in the first 24 hours post-admission (including red blood cells, frozen fresh plasma and platelets). The secondary endpoints are the amount of each blood product transfused in the first 24 hours, time to achieve prothrombin time ratio < 1.5, time to hemostasis, number of thrombo-embolic events at 28 days, mortality at 24 hours and 28 days, number of intensive care unit (ICU)-free days, number of ventilator-free days during ICU stay, number of hospital-free days within the first 28 days, hospitalization status at day 28, Glasgow outcome scale extended for patients with brain lesions on initial cerebral imaging, and cost of each strategy at day 8 and 28. Inclusions have started in December 2017 and are expected to be complete by June 2021. Discussion: If PCC reduces total blood consumption at day one after severe trauma, this therapy, in adjunction to a classic massive transfusion protocol, may be used empirically on admission in patients at risk of massive transfusion to enhance coagulation. Moreover, this treatment may decrease blood product related complications and may improve clinical outcome after post-traumatic hemorrhage. Trial registration: This study has been prospectively registered on clinical trial on July 14, 2017 NCT03218722


2016 ◽  
Vol 117 (6) ◽  
pp. 775-782 ◽  
Author(s):  
B. Nascimento ◽  
J. Callum ◽  
H. Tien ◽  
H. Peng ◽  
S. Rizoli ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document