scholarly journals Four-Factor Prothrombin Complex Concentrate to Reduce Post-Traumatic Hemorrhage in Patients with Major Trauma, the PROCOAG Trial: Study Protocol for a Randomized Multicenter Double-Blind Superiority Study

2021 ◽  
Author(s):  
Pierre Bouzat ◽  
Jean-Luc Bosson ◽  
Jean-Stéphane David ◽  
Bruno Riou ◽  
Jacques Duranteau ◽  
...  
Keyword(s):  
Prothrombin Complex Concentrate ◽  
Blood Product ◽  
Massive Transfusion ◽  
Severe Trauma ◽  
Trauma Patients ◽  
Double Blind ◽  
Massive Transfusion Protocol ◽  
Post Traumatic ◽  
Traumatic Hemorrhage ◽  
Transfusion Protocol

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

scholarly journals Four-factor prothrombin complex concentrate to reduce allogenic blood product transfusion in patients with major trauma, the PROCOAG trial: study protocol for a randomized multicenter double-blind superiority study

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Pierre Bouzat ◽  
Jean-Luc Bosson ◽  
Jean-Stéphane David ◽  
Bruno Riou ◽  
Jacques Duranteau ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Prothrombin Complex Concentrate ◽  
Blood Product ◽  
Massive Transfusion ◽  
Severe Trauma ◽  
Trauma Patients ◽  
Double Blind ◽  
Massive Transfusion Protocol ◽  
Post Traumatic ◽  
Transfusion Protocol

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

Intraoperative Resuscitation by Specialized Trauma Nurse Clinicians Improves Adherence to Massive Transfusion Protocol

2020 ◽  
Vol 86 (1) ◽  
pp. 35-41
Author(s):  
L. Andrew May ◽  
Kevin N. Harrell ◽  
Christopher M. Bell ◽  
Angela Basham-Saif ◽  
Donald E. Barker ◽  
...  
Keyword(s):  
Blood Product ◽  
Trauma Registry ◽  
Massive Transfusion ◽  
Blood Products ◽  
Packed Red Blood Cells ◽  
Massive Blood Loss ◽  
Massive Transfusion Protocol ◽  
Nurse Clinicians ◽  
Level I ◽  
Transfusion Protocol

A massive transfusion protocol (MTP) was implemented at a Level I trauma center in 2007 for patients with massive blood loss. A goal ratio of plasma to pheresed platelets to packed red blood cells (PRBCs) of 1:1:1 was established. From 2007 to 2014, trauma nurse clinicians (TNCs) administered the MTP during initial resuscitation and anesthesia personnel administered the MTP intraoperatively. In 2015, TNCs began administering the MTP intraoperatively. This study evaluates intraoperative blood product ratios and crystalloid volume administered by anesthesia personnel or TNCs. A retrospective review of trauma registry patients requiring MTP from 2007 to 2017 was performed. Patient data were stratified according to MTP administration by either anesthesia personnel (2007–2015) or TNCs (2015–2017). Ninety-seven patients were included with 54 anesthesia patients and 44 TNC patients. Patients undergoing resuscitation by MTP administered by TNCs received less median crystalloid (3000 mL vs 1500 mL, P < 0.001). The ratio of plasma:PRBC (0.75 vs 0.93, P = 0.027) and platelets:PRBC (0.75 vs 1.04, P = 0.003) was found to be significantly closer to 1:1 for TNC patients. MTP intraoperative blood product administration by TNCs reduced the amount of infused crystalloid and improved adherence to MTP in achieving a 1:1:1 ratio of blood products.

scholarly journals Not only in trauma patients: hospital-wide implementation of a massive transfusion protocol

2013 ◽  
Vol 24 (3) ◽  
pp. 162-168 ◽  
Author(s):  
L. M. Baumann Kreuziger ◽  
C. T. Morton ◽  
A. T. Subramanian ◽  
C. P. Anderson ◽  
D. J. Dries
Keyword(s):  
Massive Transfusion ◽  
Trauma Patients ◽  
Massive Transfusion Protocol ◽  
Transfusion Protocol

scholarly journals Effects of a hospital-wide introduction of a massive transfusion protocol on blood product ratio and blood product waste

2015 ◽  
Vol 8 (4) ◽  
pp. 199 ◽  
Author(s):  
Kirsten Balvers ◽  
Michiel Coppens ◽  
Susan van Dieren ◽  
IngeborgH.M. van Rooyen-Schreurs ◽  
HenriëtteJ Klinkspoor ◽  
...  
Keyword(s):  
Blood Product ◽  
Massive Transfusion ◽  
Product Ratio ◽  
Massive Transfusion Protocol ◽  
Transfusion Protocol

scholarly journals Comparison of the impact of applications of Targeted Transfusion Protocol and Massive Transfusion Protocol in trauma patients

2017 ◽  
Vol 70 (6) ◽  
pp. 626 ◽  
Author(s):  
Shahram Paydar ◽  
Hosseinali Khalili ◽  
Golnar Sabetian ◽  
Behnam Dalfardi ◽  
Shahram Bolandparvaz ◽  
...  
Keyword(s):  
Massive Transfusion ◽  
Trauma Patients ◽  
Massive Transfusion Protocol ◽  
The Impact ◽  
Transfusion Protocol

The Use of Recombinant FVIIa in a Structured Massive Transfusion Protocol: A Novel Approach.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4142-4142
Author(s):  
Majed A. Refaai ◽  
Kathryn Tchorz ◽  
John Forestner ◽  
Raymond Morris ◽  
Marty Koch ◽  
...  
Keyword(s):  
Massive Transfusion ◽  
Blood Type ◽  
Blood Component ◽  
P Value ◽  
Trauma Patients ◽  
Blood Products ◽  
Packed Red Blood Cells ◽  
Massive Transfusion Protocol ◽  
Novel Approach ◽  
Transfusion Protocol

Abstract Background: Trauma has become the second leading cause of death worldwide, despite advances in modern trauma resuscitation practices. Appropriate and timely blood component therapy in the severely injured trauma patient could prevent adverse outcome due to coagulopathy. Recombinant FVIIa has been used to achieve adequate hemostasis in trauma patients in the field. Materials and Methods: In June 2004, a massive transfusion protocol (MTP) was established in Parkland Memorial Hospital in Dallas, TX for patients presenting with trauma. Major goals of the MTP were 1) to achieve faster turn around times for these products, 2) to provide an appropriate ratio of blood components in order to prevent coagulopathy of massive transfusion and use of rFVIIa to achieve better hemostasis, and 3) to reduce wastage of blood products. At all times, the Blood Bank keeps ready for emergency release 4 units each of type A and O thawed plasma (TP) and 2 units of AB TP (5 days expiration). The MTP consists of three shipments that may be repeated, if necessary. Each shipment consists of 5 packed red blood cells (PRBCs) and 2 TP. One dose of platelets is added to the second shipment, and one dose of cryoprecipitate (10 units) and rFVIIa (4.8 mg) is added to the third shipment. If the MTP goes to the 6th shipment, 2.4 mg rFVIIa is given. Once initiated, the first MTP shipment is ready for pick up in 15 minutes. If blood type can not be determined, type O RBCs with type AB TP are sent in the first shipment (Rh matching depends upon inventory and the patient’s gender). We compared MTP blood component usage in 173 trauma patients during a 24-months period with pre-MTP historical data in 67 trauma patients from the previous 12 months. Results: The average TAT of the first shipment in MTP was 9 ± 0.4 minutes. No TAT assessments of the first shipment were possible in the pre-MTP cases because there was no initiation time available. When comparing the average TATs of second and third shipments of MTP versus pre-MTP cases, however, significant reductions were achieved (18 ± 1.8 vs. 42 ± 30 and 30 ± 2.5 vs. 44 ± 31 minutes, respectively). There was a significant reduction in blood component usage with MTP as compared to pre-MTP (Table) though the mortality had not changed. The blood component wastage (especially cryoprecipitate) had decreased significantly. Conclusions: There was a significant reduction in TAT and blood products used in following establishment of MTP; this was most likely due to prevention and/or early treatment of dilutional coagulopathy and achievement of adequate hemostasis with use of rFVIIa. Table Group PRBCs Thawed Plasma Platelets CRYO rFVIIa TAT (2nd Shipment) TAT (3rd Shipment) *Pre-MTP (n = 20), CRYO = cryoprecipitate, TAT = turn-around time, N/P = not performed Pre-MTP (n = 67) 24.2 ± 16.3 11.2 ± 8.3 3.1 ± 3.5 1.6 ± 1.7 0.2 ± 0.4 42 ± 30* 44 ± 31* MTP (n = 173) 17.5 ± 12.4 6.7 ± 5.6 1.2 ± 1.4 0.7 ± 0.8 0.4 ± 0.6 18 ± 1.8 33 ± 2.5 P value 0.0055 &lt;0.001 &lt;0.001 &lt;0.001 00.0032 N/P N/P

scholarly journals Fluid Resuscitation and Massive Transfusion Protocol in Pediatric Trauma

2016 ◽  
Vol 33 (2) ◽  
pp. 91-99
Author(s):  
Vesna Marjanović ◽  
Ivana Budić
Keyword(s):  
Hemorrhagic Shock ◽  
Fluid Resuscitation ◽  
Early Identification ◽  
Massive Transfusion ◽  
Pediatric Trauma ◽  
Current Data ◽  
Trauma Patients ◽  
Volume Resuscitation ◽  
Massive Transfusion Protocol ◽  
Transfusion Protocol

Summary Trauma is the leading cause of morbidity and mortality in children due to the occurrence of hemorrhagic shock. Hemorrhagic shock and its consequences, anemia and hypovolemia, decrease oxygen delivery, due to which appropriate transfusion and volume resuscitation are critical. Guidelines for massive transfusion, in the pediatric trauma, have not been defined yet. Current data indicate that early identification of coagulopathy and its treatment with RBSs, plasma and platelets in a 1:1:1 unit ratio, and limited use of crystalloids may improve survival in pediatric trauma patients.

scholarly journals Tranexamic Acid (TXA) in Trauma Patients: Barriers to Use among Trauma Surgeons and Emergency Physicians

2017 ◽  
Vol 2017 ◽  
pp. 1-5 ◽  
Author(s):  
Abdulaziz Alburaih
Keyword(s):  
Tranexamic Acid ◽  
Massive Transfusion ◽  
Positive Impact ◽  
National Level ◽  
Trauma Patients ◽  
Emergency Physicians ◽  
Major Barrier ◽  
Massive Transfusion Protocol ◽  
Trauma Surgeons ◽  
Transfusion Protocol

Objective.Tranexamic Acid (TXA) is currently the only drug with prospective clinical evidence supporting its use in bleeding trauma patients. We sought to better understand the barriers preventing its use and elicit suggestions to further its use in trauma patients in the state of Maryland.Methods. This is a cross-sectional study.Results. The overall response rate was 38%. Half of all participants reported being familiar with the CRASH-2 trial and MATTERs study. Half reported being aware of TXA as part of their institution’s massive transfusion protocol. The majority of participants felt that TXA would have a significant positive impact on the survival of trauma patients. A majority also felt that the use of TXA would increase if its administration was the responsibility of both trauma surgeons and emergency physicians.Conclusion. Only half of responders reported being aware of TXA as being part of their institution’s massive transfusion protocol. Lack of awareness of the clinical data supporting its use is a major barrier. However, most trauma providers and emergency physicians do have a favorable view of TXA and support its incorporation into massive transfusion protocols. We believe that more studies of this kind on both state and national level are needed.

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