"Formula-Driven" Versus "Lab-Driven" Massive Transfusion Protocols: At a State of Clinical Equipoise

Unfortunately, we are likely years away from having the answer to settle this debate. The necessary RCTs will be difficult to complete. We would be smart to perform some small pilot studies to identify all of the challenges to a multicenter trial in this difficult patient population. The trials will not be able to be performed without a "waived" consent because of the inclusion of only massively injured patients. The patients will have to be randomized almost immediately upon arrival to the trauma room because of the need to commence formula-driven care along with the first RBC. The blood banks will have to be actively involved to ensure rapid preparation of blood components. In addition, we also have to ensure that the "standard" arm is given appropriate laboratory-driven component support, with prompt turnaround times for coagulation testing. The studies on formula-driven care do not show unequivocal benefit or unequivocal harm. We should not jump toward adopting formula-driven care without considering the potential risks and benefits for trauma patients, and our other patients who require FFP. We thus will need to keep the doors open for such a much needed clinical trial. If formula-driven care is adopted and accepted as standard of care in most trauma hospitals, where will such a trial be done? © 2009.