An Observational Study of Early Coagulopathy, or Clotting Disorder, in Injured Patients

Trauma continues to be the major killer of young Americans, mainly due to hemorrhage or
brain injury. In trauma centers, up to a quarter of these severely injured patients arrive
with a coagulopathy and thereby experience an increased risk of death, despite the current
standard of medical and surgical management. The PI for this grant proposal is a
fellowship-trained trauma surgeon who works full-time at Grady Memorial Hospital (GMH), the
only Level I Trauma Center in Atlanta. It is only one of four Level 1 trauma centers for the
entire state of Georgia. This research is a direct extension of the retrospective research
the PI has previously published. Her retrospective research discovered a previously
undescribed form of coagulopathy, early trauma induced coagulopathy (ETIC), which cannot be
explained by present paradigms. Two civilian trauma articles as well as military data from
the Iraq war have substantiated the occurrence of ETIC, but no prospective literature has
defined it or its kinetics. More importantly, the results from these studies represent a new
paradigm shift, in which ETIC appears to be a primary dysfunction which is independently
associated with death. Therefore, its early identification and correction is crucial for our
mechanistic understanding, and ultimately, our choice of interventions and improved
survival. GMH is a high-volume trauma center that sees patients with a variety of injury
mechanisms, and, therefore, is the perfect setting to confirm ETIC. First, the project will
confirm the prevalence of ETIC with an observational prospective cohort of injured patients.
Data on the coagulation system and risk factors, both known and suspected, of all patients
will be collected upon patient arrival as well as patient outcome with all identifying
information protected. This is the first prospective research project that will allow
simultaneous control of confounders associated with outcome and thereby scientifically
validate the occurrence of ETIC. One unique component of our data collection is a focus on
the timing of events as they relate to the development and consequences of coagulopathy, to
account for the dynamic process. At the completion of data collection, a matched cohort of
ETIC and non-ETIC blood samples will be tested for coagulation factors to provide insight
into ETIC's pathophysiology. In the short term, our conclusions will assist us in our
approach to resuscitation of the bleeding trauma patient as some trauma centers have already
started to change protocols based on our present incomplete understanding of trauma-induced
coagulopathy. In addition, the coagulation system data collected in this study will lead to
pathophysiological answers and to more refined hypotheses for future research at a
coagulation system level. Ultimately an understanding of ETIC will lead to a more effective,
tailored treatment. Our main study hypothesis is that post-trauma coagulopathy is a primary
dysfunction that occurs early after a traumatic event in up to 25% of all trauma patients
triaged to Trauma Center care.