Multi-institutional Phase 2/3 Trial of Fresh Frozen Plasma (FFP) in Patients with Moderate to Severe Traumatic Brain Injury (TBI)

LAY ABSTRACT Injury to the brain, also called traumatic brain injury (TBI) afflicts nearly 2 million people in the United States of America, and 50 Million worldwide, every year. It is especially relevant for our military, where TBI can been labelled as the “signature injury” during the recent/current conflicts. Not only is it a major cause of death, those that survive suffer from prolonged disability, pain, chronic mental and physical issues such as depression, memory loss and post-traumatic stress disorder (PTSD). Currently, we lack any effective treatments that can protect the brain after such injury, and to speed up its healing process. There is emerging new information that a plasma (liquid component of blood), if injected into the blood stream early after injury can protect the brain. In addition to appropriate animal studies, there are some exciting findings from studies that were designed to monitor the benefits of plasma administration in severely injured patients that were bleeding. Some of these patients also had brain injuries, and analysis of this sub-group seems to suggest that administration of plasma improved outcomes. Our goal now is to obtain information about the benefits of early plasma administration in a study that is specifically designed to monitor its effects on the brain. We will allocate patients suffering from moderate to severe brain injury to receive either standard supportive care, or to get standard supportive care and about 16 ounces of plasma infusion into a vein within 3 hours from the time of injury. We will then closely monitor the patients to determine the ability of the plasma treatment to decrease the extent of brain damage, and to speed up the healing process. If successful, this can provide a new treatment for civilian and military personnel suffering from brain injuries, which can potentially improve the lives and minimize the suffering of countless individuals.