Identification of Patients
To ensure that the injured patient cohort identified
for entry is at sufficient risk for the development of MOFS, infectious complications, and death,
entry criteria include those describing severe physiologic derangement
due to blunt injury. These criteria include the following:
- Evidence of a significant, physiological impact by blunt trauma, as defined by an episode of hypotension (systolic blood pressure lower than 90 / palpable) either in the field or Emergency Room setting
- Metabolic alterations consistent with significant dysfunctional tissue perfusion and easily obtained through initial blood gases, as defined by acidosis measured by base deficit of greater than 6 on arterial blood gas
- Blood transfusion required to treat severe acute anemia from blunt trauma hemorrhage during the first 12 hours
Enrolled patients must be greater than 16 years old in order to establish a reasonably uniform patient
The absence of devastating head injury must be confirmed with a Glasgow
Coma Score (GCS) greater than 8. Mechanism of blunt trauma must be ascertained
to standardize the contribution of physiologic derangement in concert
with blunt tissue trauma.
Protocols for Standard Patient Care
The extent of initial resuscitation efforts and the
subsequent care of an injured patient have a significant impact on whether
the patient recovers or experiences complications, including the development
of MOFS and death. Such variability in clinical care would also be expected
to impact proteomic and genomic expression patterns. To obviate these
concerns, the Patient-Oriented Research Core Trauma Research Group has developed standardized
protocols for patient care. These SOPs, developed through consensus
among the investigators at the participating centers, are grounded in
evidence-based medicine. As implemented, they are considered the standard
of care for patient management and are mandated for all enrolled
patients as well as for uniform routine care at each of the participating
The Journal of Trauma has accepted the trauma SOPs as a series and each will appear in a separate journal publication.
- Acute ventilatory management
- Treatment of ventilator-associated pneumonia
- Shock resuscitation
- Sedation and analgesia
- Venous thromboembolism
- Cardiac support
Subsequently, it is hoped that the adoption of these evidence-based approaches to patient care will improve the clinical outcome of trauma patients across the nation. In addition, the adoption of SOPs for clinical care will set the stage for later modifications and potential improvements for care in future randomized, controlled trials designed to further enhance trauma-directed resuscitation and care.
Participating Medical Centers
To ensure standardized care and uniformity of clinical
application to all enrolled injured patients, the trauma research group
selected participating centers that have a long-standing interest and
research background in the clinical care of severely injured patients.
Centers were selected based both on their documented research background
and also on the documented volume of patients visiting the center.
There are now eight Level I trauma or burn centers participating in the clinical studies of our collaborative project. The trauma centers include Harborview Medical Center (University of Washington in Seattle), UT Southwestern Medical Center (University of Texas at Southwestern in Dallas), Denver General Health Center (University of Colorado), and Presbyterian Medical Center (University of Pittsburgh).
A data abstraction tool and system has been developed
by the Information Dissemination and Data Coordination (IDDC) core.
This database tool houses coded data on severely injured patients,
further defines the potential identifiers of risk for MOFS and death,
confirms the use of standardized processes of care, and documents pertinent
clinical endpoints such as MOFS and death.
The tool also captures resource consumption such as total length
of stay and ICU length of stay.
Trial/DB, a non-proprietary Web-based platform developed by Yale
University, has been used for the development of clinical data capture to ensure conformity, user
friendliness, and consistency across multiple institutions for the enrollment
of patient data.
To date, program researchers have established SOPs for clinical care involving
resuscitation of the trauma patient, management of acute respiratory failure,
weaning from mechanical ventilation, and the diagnosis and management
of ventilator-associated pneumonia. The remaining SOPs are expected to be refined and published in 2007 and 2008. The trauma research group core has also developed standardized diagnostic criteria for complications.
Doing so ensures consistent reporting and quality assessment of treatment
and outcomes among the participating trauma centers. Utilization of SOPs
along with standardized tracking of complications should pave the way
for consistency in future multicenter trials assessing the impact of outcomes
on interventional therapies in the severely injured patient population
Trauma patient recruitment and enrollment is ongoing to meet the challenges of performing and interpreting serial genomic and proteomic determinations in critically ill trauma patients at high risk for multiple organ failure or death, while generating an epidemiological database containing detailed physiologic, anatomic, and outcomes data that heretofore has not been possible in single-center cohort studies.