Factor VII (Seven) is a protein produced by humans that will stop bleeding by making the blood clot. Factor VII is produced by the pharmaceutical industry into ‘recombinant activated factor VII’ which is a much under utilized medication that likely represents a life-saving treatment for those with catastrophic injuries and medical conditions causing uncontrolled bleeding. Shamefully it is under utilized because it is ‘cost prohibitive’ at a cost of $4,500 per dose. This treatment is safe and likely ‘cost effective’ because of the productive lives saved, decreased hospital length of stays, and increased cost of the resulting morbidity and disability associated with uncontrolled bleeding.
An inevitable ‘immediate’ consequence of severe bodily trauma is bleeding and unfortunately an inevitable ‘delayed’ consequence of severe bleeding is more bleeding because of the body’s inability to clot bleeding vessels and capillaries in the face of severe bodily trauma. ‘Recombinant activated factor VII’ has been available for years and appears to be the medical answer for severe bleeding that clinically appears to be safe and effective. Unfortunately, but for the cost of ‘recombinant activated factor VII’, patients with uncontrolled bleeding continue to die and suffer blood loss related morbidity and complications simply because of its cost.
Current medical management for severe bleeding includes blood replacement, platelets, and plasma. Unfortunately severe trauma produces a unique coagulopathy (bleeding disorder) that is poorly understood with little agreement regarding treatment and management. Severe trauma induces a coagulopathy that is related to the normal bodily response to bleeding that consumes all of the functional platelets and clotting factors. It is not uncommon in the case of severe injury that injured tissues simply ooze blood without a distinct arterial laceration because of this coagulopathy. Tremendous blood loss may result. Unfortunately this unique coagulopathy affects approximately 36% of trauma patients and current medical management is insufficient to stop bleeding and potentially avoid complications and death in many circumstances.
Studies have provided evidence that severe bleeding related to postpartum uterine hemorrhage, cardiac surgery, and severe trauma can be effectively treated with ‘recombinant activated factor VII’ with studies indicating that patients who receive this medication require significantly less blood transfusion, platelets, and plasma.
Dr. Greg Vigna, MD, JD, an Academic Physician Life Care Planner states, “the under utilization of recombinant activated factor VII in trauma is related to economics. The studies to date indicate that it is safe and effective, but until payer sources recognize it as the standard of care in the setting of severe bleeding caused by trauma it will be under utilized”.
Dr. Vigna adds, “Recombinant activated factor VII isn’t the standard of care because of the $4,500 per dose is somewhat prohibitive. Until studies are taken to the second level that shows that not only lives are saved but dollars are saved, trauma surgeons will not be free to utilize this medication for severe bleeding caused by the various abdominal injuries, thoracic injuries, and catastrophic pelvic fractures that they treat.”
Acute respiratory distress syndrome (ARDS) may be the diagnosis that produces the cost benefit analysis that supports the use of ‘recombinant activated factor VII’. Studies indicate that patients requiring five units of blood, large volumes of intravenous fluids during the first 24-48 hours, or those with blood loss approximating 2.5 liters are at significant risk of ARDS.
The cost of ARDS simply related to ‘transfusion-associated ARDS’ is nearly six hundred million dollars per year. Every patient with ARDS will require prolonged intensive care management and prolonged ventilator support. Medical and non-medical cost related to ARDS approximates 200 to 300 thousand dollars per patient and carries a mortality between twenty-five and forty percent. Understanding that simply keeping the necessary transfusions below five units of blood by utilizing ‘recombinant activated factor VII’ acutely during the critical first 24-48 hours following trauma may prove that it is cost effective because of the resulting decreased incidence of ‘transfusion-associated ARDS’.
Dr. Vigna states, “Unfortunately trauma patients are a diverse population with an infinite number of variables that makes studies virtually impossible to conclusively prove that an intervention is ‘cost effect’ in trauma. What needs to be done when it comes to potentially life saving medical interventions that are cost prohibitive is for medical studies to be sponsored by the Federal Government. If these studies prove that ‘recombinant activated factor VII’ is a safe and effective we should have ample supplies ready for our military personnel and available at Level I and Level 2 Trauma Centers across the country”.