The Use of Recombinant FVIIa in a Structured Massive Transfusion Protocol: A Novel Approach.
Authors: Refaai Majed A. , Tchorz Kathryn , Forestner John , Morris Raymond , Koch Marty , Hampton Scott , Sarode Ravindra 
Published: April 2020

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