SC2i’s concept is to develop an Integrative approach that focuses care around individual patient biology, rather than on the traditional critical care model, in which care is typically guided by a population-based paradigm.
Tissue and Data Acquisition Protocol (TDAP):
This tissue and data acquisition protocol (TDAP) project serves as a standardized method for collecting clinical data and biological specimens from properly identified patients and healthy volunteers in support of the SC2i-approved initiatives. General procedures covered under this protocol will include clinical sample acquisition, processing and storage, clinical data capture and storage, and the sharing or data and samples amongst SC2i partners. It is an observational study meant to collect data and samples relevant to the care of critically injured individuals. It is not intended to alter the care of participants, but could be used in tandem with approved interventional or other observational studies to facilitate standardized collection processes across all SC2i activities.
The TDAP will involve cross-sectional and longitudinal evaluation of individuals with established injury or illness requiring surgical management and/or management within a surgical critical care setting. These will include operating rooms, surgical wards, emergency rooms, wound care clinics, outpatient surgery clinics and rehabilitation settings. Non-injured healthy control subjects encountered in these settings will also be studied. Scientific assays performed using samples or data obtained under this protocol will not be used clinically or influence clinical care.
The SC2i Tissue and Data Acquisition Protocol will reduce associated time and costs for repeating the protocol/IRB procedures with each SC2i project, it will maximize specimen retrieval, and it will standardize sampling and analysis procedures across the entire SC2i. The critical care tissue acquisition protocol is the corner stone for the success of SC2i. Through the use of a standardized TDAP, the SC2i leverages resources in the most efficient use to maximize productivity for all critical care focus projects the program will model.
Timing of debridement and closure (WounDX):
The appropriate timing and frequency of wound debridements for traumatic wounds (including burns) are currently controversial and based largely on historical expert opinions derived from civilian orthopaedic trauma experience. We need objective criteria to guide the timing of debridement and identify wounds that require either less frequent debridement procedures or are amenable to early closure. We will leverage SC2I resources and collaborations to process data obtained from wound effluent and tissue biomarker analysis in an FDA IDE trial. This validated CDS tool is designed to guide the timing of wound closure in traumatic wounds as well as to establish criteria for both the number and frequency of wound debridement, on a wound-specific basis.
Invasive Fungal Infections (IFI):
Invasive fungal infections (IFI) represent an emerging devastating complication of combat wounds. We previously determined that distinct cytokine and clinical profiles are associated with IFI’s and will develop predictive models using SC2I technology to diagnose these devastating infections early and institute treatment at an accelerated pace. This will be accomplished using a combination of existing data and patients currently enrolled in studies in the National Capital Area (NCA) and Emory.
Massive Transfusion Protocol:
Determining whether a massive transfusion is required, is often difficult for the bedside clinician. Doing so requires him or her to codify and at times, synthesize many complex data points that vary over time. Because massive transfusions are resource intensive and expensive, it requires quick and accurate decision-making. As such, this clinical scenario is uniquely suited for a CDS application, since accuracy and efficiency can result in improved patient outcomes and cost savings to the institution. Based on our experience with massive transfusion and the predictive value of admission base deficit measurements, we created a Smartphone Application that allows for the accurate prediction of massive transfusion based on a sophisticated statistical model created using admission variables readily available to the clinician at the bedside. SC2i will prospectively study the accuracy and usefulness of this application in real-time prediction of massive transfusion in critically injured patients.
Damage Control Laparotomy - Open Abdomen:
Damage control laparotomy (DCL) followed by temporary abdominal closure (TAC), resuscitation in the ICU and planned re-laparotomy is often used to manage critically injured patients who cannot be closed primarily at the initial operation. In fact, up to 25 percent of all trauma laparotomies require management with open abdomens. The appropriate timing of abdominal closure or coverage has yet to be determined, making this scenario ideally suited for a relevant CDS tool. Moreover, no studies to date have evaluated objective criteria for predicting successful closure of the open abdomen after DCL. Therefore, the SC2i will conduct a prospective observational trial to define biomarkers as objective criteria that will be used to develop a CDS tool, for this purpose.
Traumatic Brain Injury (TBI):
Severe TBI (sTBI, GCS 3-8) caused by direct penetration or blunt force is often accompanied by secondary injury due to anatomic and biochemical processes, treated with hemicraniectomy and CSF drainage. Key decisions regarding diagnosis of vasospasm, antibiotic therapy, removal of CSF access, and bony reconstruction are made based upon examination, monitoring, lab and imaging studies, and clinical judgment. Understanding immunologic implications with a mechanistic focus directed towards clinically translatable therapeutic manipulation, and their consequences, calls for the development of accurate CDS tools. Developing one within the SC2i will allow us to better tailor therapies and interventions to these very complicated patients.
The Physiologic Decompensation project will provide real-time analytics to create situation awareness to enhance care. These analytics will be used to inform caregivers about the states of individual patients as well as collections of patients. “Collection of patients” will be scalable, to include a physical ICU, a collection of physical ICUs or even a virtual ICU encompassing a cross section of patients from multiple locations. Thus “collection” could include a cohort of brain-injured patients across several continents and even airborne during transport among facilities. The general intent of this project is to accelerate individualized treatments and provide rapid decision support based on the early detection of physiologic decompensation with the overall tripartite goal of better health, better care and lower costs for both military and civilian populations.