Clinical Research Directory

Onyx™ Liquid Embolic IDE Clinical Study

The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.

Animal Assisted Therapy

This study looks at whether walking with a therapy dog helps adult and pediatric trauma patients move more during their hospital stay. Early movement after an injury or surgery can prevent problems such as blood clots, pressure sores, and muscle loss, but pain and anxiety often make it hard for patients to get out of bed. Each patient in this study takes part in two walking sessions-one with a certified therapy dog and one without a dog. The order is randomized, so some patients walk with the dog first and others walk without the dog first. Before and after each walk, patients fill out short surveys about their pain, anxiety, and motivation to move. The research team measures how far and how long each patient walks in both sessions. The goal of this project is to see if therapy dog visits can safely and effectively improve mobility, reduce pain and anxiety, and make walking more enjoyable for trauma patients. Findings from this study may help hospitals design better rehabilitation programs that use animal-assisted therapy to support physical and emotional recovery.

Neuroendocrine Risk for PTSD in Women

This study will test for effects of estradiol (E2) on PTSD symptoms and functional magnetic resonance imaging (fMRI) indicators of stress vulnerability, in naturally-cycling women who are not using hormonal birth control. Enrollment will be targeted to create three groups within two cohorts (early follicular phase and luteal phase): 1. PTSD: Women who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for PTSD 2. Trauma-Exposed (TC): Women matched for age and trauma exposure severity but without PTSD 3. Healthy Control (HC): Women matched for age, but without trauma history or psychiatric disorder (self-reported) Women will be recruited through Grady Trauma Project (GTP), a large longstanding study of civilian trauma and PTSD conducted at Grady Memorial Hospital in Atlanta, Georgia.

OCT in Open Fracture and Infected Fracture

This is a pilot prospective, observational study of patients with open or infected fracture evaluating the feasibility and acceptability of OCT, a light-based imaging modality that requires no drug or contrast agent.

Multicentre Study: Adherence to the Severe Trauma Patients Pathway in PACA Region

Trauma patient management concerns more than 140,000 patients per year in France. PACA Regional Emergency Observatory (ORU) has issued recommendations to optimize the management of these trauma patients from pre-hospital phase to hospitalization first hours. Ideally, pre-hospital care should not exceed 60 minutes, from accident (first call to the SAMU) to trauma center arrival: the "golden hour" concept. Patients presenting at least one of the Vittel criteria are considered as severely traumatized and are classified according to 3 states of seriousness: unstable, critical and potentially serious. They are referred to trauma centers whose classification is based on their technical facilities, ranging from level 1 (maximum technical facilities) to level 3 (minimum technical facilities). Patients are referred according to their severity, distance from accident site, referral center and availability of each site. Initial hospital management recommends a whole body CT scan within 45 minutes for patients categorized as unstable or critical by pre-hospital doctor and 90 minutes for patients deemed potentially serious. FILTRAUMA PACA study will analyze the impact of the different management sequences of severe trauma patients based on reliable temporal data because it is automatically incremented in databases and will seek to find a correlation with patient outcome (survival at 24 hours and 28 days). The main hypothesis tested is that PACA ORU recommended delay respect during trauma patient initial management is correlated with vital prognosis in short (24 hours) and medium terms (28 days).

Hospital Based Continuous Patient Monitoring System

In Ghana, and many other low and middle income countries in Africa, manual vital signs monitoring is the prevalent mode of vital signs monitoring because continuous bedside monitors are non-functional. This lack of continuous vital signs monitoring may result in missed opportunities to catch physiologic deterioration. The investigators propose to develop a dashboard that is based on the Garmin Venu 3, a consumer wearable device that reliably measures heart rate, SPO2, and respiratory rate, as an alternative to bedside monitors in hospitals in Ghana.

PRIORITI-MTF Study- Testing Patient Response to the IDEO

The goal of the PRIORITI-MTF study is to help determine whether a new type of custom designed brace, called the IDEO ™ along with a physical therapy program, called Return to Run, improves physical function. This brace was developed for wounded warriors who wanted to return to an active lifestyle. The primary objective of this study is to examine the benefits (and cost-benefits) of an integrated orthotic and rehabilitation program that incorporates the Intrepid Dynamic Exoskeletal Orthosis (IDEO) and the Return to Run (RTR) physical therapy regimen, but designed for scalability in the broader military environment (i.e. beyond San Antonio Military Medical Center where the program was developed)

A Pilot Participatory Program Evaluation of a Virtual Trauma Support Program for Autistic Adults

The goal of this single-group clinical trial is to learn about the initial efficacy and feasibility of telehealth-delivered Written Exposure Therapy (WET) for autistic adults with traumatic stress symptoms. The main questions the investigators aim to answer are: * Do symptoms of posttraumatic stress disorder (PTSD) and co-occurring mental health concerns decrease after receiving WET? * Do biobehavioral health outcomes, including objective (Fitbit indicators of activity, sleep, and heart rate) and subjectively-reported health variables (e.g., sleep, pain, health-related quality of life), improve after receiving WET? * How do autistic adults experience WET, and how can this program be modified and enhance in the future in collaboration with autistic adults? Participants will complete the following as part of the study, which is completed entirely over telehealth. * Participants will first complete an initial assessment, involving brief measures of cognition and autistic traits, as well as interviews and questionnaires about PTSD, mental health, and physical health. If eligible, participants will proceed to the following steps: * Eligible participants will then start wearing a Fitbit, to be used for the duration of the study. * Participants will then participate in 5 weekly virtual visits involving the WET protocol, including weekly brief assessment of PTSD and mental and physical health. * Then, participants will complete a sixth virtual visit the following week where PTSD, mental and physical health, and treatment feedback are assessed. * Lastly, participants will complete virtual visits 1 and 6 months later involving re-assessment of PTSD and mental and physical health. Therefore, this is a pre-post single group design, where all participants will receive WET to establish initial efficacy and feasibility. Investigators will also consult with an autistic advisory board throughout the project, and make adaptations as recommended in consultation with autistic adults. The goal is to better understand the initial efficacy and feasibility of WET for supporting autistic adults who have experienced trauma.

Preventing Harmful Alcohol Use Among Trauma Patients in Cameroon

\*\*Brief Summary\*\* Alcohol use is a major contributor to injury burden in Cameroon, particularly among trauma patients presenting to emergency departments. Despite the strong association between alcohol use and injury, structured alcohol screening and intervention programs are not routinely integrated into trauma care in Cameroon. This study aims to evaluate a Cameroon-adapted Screening, Brief Intervention, and Referral to Treatment (SBIRT) program for trauma patients at the Limbe Regional Hospital. The study will be conducted in three phases: (1) training emergency department healthcare providers on a culturally adapted SBIRT program; (2) evaluating the feasibility, acceptability, and fidelity of SBIRT implementation in routine emergency care; and (3) assessing the effectiveness of SBIRT in reducing harmful alcohol use among trauma patients. Healthcare workers will be trained to deliver SBIRT, and eligible trauma patients screening positive for risky alcohol use will be enrolled in a randomized waitlist-controlled trial. Participants will undergo alcohol screening using validated tools and will be followed for six months. Outcomes will include alcohol use measured by the Alcohol Use Disorders Identification Test (AUDIT), phosphatidylethanol (PEth) biomarker levels, referral uptake, implementation outcomes, and patient well-being measures. The study is expected to generate evidence on the feasibility and effectiveness of integrating alcohol interventions into trauma care in a low-resource setting and inform future scale-up of SBIRT programs in Cameroon and similar settings.

The Effectiveness of RAPID-Based Psychological First Aid Training

This study uses a single-group pre-test-post-test follow-up design. The aim is to evaluate participants' interpersonal communication competencies and active-empathetic listening skills before and after psychological first aid training.

Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness

The purpose of this study is to investigate justice-involved Black/African American female adolescents' (JI BAFAs; N=35) self-reported outcomes: stress, posttraumatic stress disorder (PTSD), recidivism, etc., as well as their parents/caregivers' (P/Cs; N=35) stress and pre- and post- intervention results along with their views of an adapted intervention.

Litter Packaging in the Lateral Position: Effects of Position and Vacuum Mattress Packaging on Pulmonary Function

This is a study to look at the effect on breathing of various ways to package a person in a rescue litter. We will measure lung function in a litter, lying down, lying down in a vacuum mattress, one the side in a vaccum mattress, and vertical in a vacuum mattress.

Enteric Anastomoses

This retrospective data repository will serve as a means to aggregate and analyze best practices as relative to traumatic colon injury outcomes.

Comprehensive Segmental Revision System

Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.

Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

This is a prospective, randomized, controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 1:1 to either enhanced nutrition or control arm. Subjects randomized to the enhanced nutrition arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.

CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

The CAlcium and VAsopressin following Injury Early Resuscitation (CAVALIER) Trial is a proposed 4 year, double-blind, mutli-center, prehospital and early in hospital phase randomized trial designed to determine the efficacy and safety of prehospital calcium and early in hospital vasopressin in patients at risk of hemorrhagic shock.

Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients

This is a Pilot study designed to set up for an randomized clinical trial (RCT) comparing the SeND Home pathway to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 3:1 to either SeND Home precision nutrition pathway or control arm. Subjects randomized to the SeND Home arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.

Trauma-Informed Yoga Intervention in Young Women

The aim of this study is to evaluate the effects of a trauma-informed yoga intervention on psychological trauma symptoms, difficulties in emotion regulation, and interoceptive awareness in young adult women.

Prenatal Yoga Intervention in Pregnant Women

The aim of this study is to determine the effects of a prenatal yoga intervention on traumatic childbirth perception, self-perception, and delivery preferences in pregnant women.

Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction

Although other methods (e.g., autologous fat transfer, dermal-/collagen-based fillers) for soft tissue reconstruction exist, each has distinct disadvantages leaving room for improvement in this treatment area. Investigators in the Elisseeff Laboratory (Johns Hopkins University Department of Biomedical Engineering) have recently generated a novel tissue-derived material to create instructive matrices for soft tissue reconstruction called Acellular Adipose Tissue (AAT). This material takes advantage of the inherent bioactivity and unique mechanical properties of subcutaneous adipose tissue. Investigators' preclinical data suggest that AAT is safe for use in small and large animals; investigators' clinical (Phase I) data suggest that AAT is safe for use in humans. These data indicate that a Phase II, dose-escalation study of AAT's safety and efficacy in human subjects is warranted.

Data-Driven Lay First Responder Program in Cameroon

Cameroon experiences a high burden of injury-related morbidity and mortality and currently lacks a formal pre-hospital care system. Lay First Responder (LFR) programs have been implemented in several low-and middle-income countries to improve early injury care by training non-medical community members with high exposure to injury, such as commercial drivers, in basic first aid and safe transport of injured patients. The study aims to implement and evaluate a data-driven, context-adapted LFR program in Cameroon using an implementation science approach. Quantitative trauma registry data and qualitative stakeholder interviews will be used to adapt the LFR curriculum to local injury patterns and care gaps. LFR program implementation will be associated with increased chances of survival on presentation and improved trauma outcomes. The study is an interrupted time series evaluation of an LFR intervention where prehospital care rates and clinical patterns in the Cameroon Trauma Registry (CTR) patients at Limbe Regional hospital will be compared between historical pre-implementation controls and post-implementation of a data-driven lay first responder training program (the intervention).

PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.

In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety. The VERTICALE® Cervical System is intended for immobilization and stabilization of spinal segments of the craniocervical junction (occipital-C2), subaxial cervical spine (C3-C7) and upper thoracic spine (T1-T3). Primary Objective: To assess the functional outcome and clinical benefit of the VERTICALE® Cervical System for the patient using the NDI (Neck Disability Index) questionnaire. Primary endpoint hypothesis: The investigators hypothesize that NDI improves by at least 10% or 5 points at 12 months FU (Follow-Up) compared with preoperatively.

Trauma-Informed Obstetric Care: Development and Implementation of a Toolkit for Obstetrics (OBTIC)

Many pregnant women have experienced trauma, which can make perinatal care stressful and increase the risk of pregnancy-related health conditions. However, obstetric providers can modify procedures to reduce distress and enhance patients' sense of control and safety. Although obstetric providers frequently care for trauma survivors, most are not trained in trauma-informed care (TIC). Additionally, there are no data on feasibility, appropriateness, or acceptability of TIC tools and interventions in the context of obstetrics. The goal of this project is to develop the first, stakeholder-informed obstetric TIC toolkit composed of treatment protocols, clinician training, trauma and violence screening tools, and other resources to help obstetric providers apply TIC practices to all clinical interactions in addition to identifying and providing support for trauma survivors. The obstetric TIC intervention toolkit (OB-TIC) will be developed in collaboration with key stakeholders (pregnant and postpartum patients, nurses, physicians, and administrators) to ensure that it is feasible, acceptable, appropriate, cost-effective, and clinically useful. Current practices and preferences will be characterized in qualitative interviews with stakeholders which will inform the development of OBTIC in collaboration with a community working group of stakeholders. A pilot implementation trial of OB-TIC will be conducted in outpatient obstetrics clinics to gather real-world data that will inform the final intervention toolkit, which will be tested on a larger scale in future studies.

SWiFT Canada (Study of Whole Blood in Frontline Trauma)

Traumatic injuries affect people of all ages, races, and socioeconomic backgrounds. The Global Burden of Disease study showed that globally in 2019, there were more than 4.4 million deaths due to injury. Furthermore, unintentional injuries are the leading cause of death for people aged 5-29 years worldwide. Uncontrolled bleeding accounts for a significant proportion of these deaths, with approximately 20% occurring in the first 24 hours and 40% occurring within the first 30 days. Blood transfusion is a life-saving treatment in the management of bleeding patients until bleeding is controlled in hospital, typically delivered through different blood components (red blood cells, plasma and platelets). These components are derived from a whole blood donation and are stored in separate bags (units). There are challenges in carrying separate blood products, such as additional weight in kit bags, and transfusing multiple blood products at the scene can delay transport to hospital. In Ontario, Ornge Air Ambulance carries red blood cells and plasma to transfuse prehospital. However, a prehospital transfusion strategy has not been established and practice varies across the Canadian setting, and more broadly across the world. This trial aims to investigate if carrying and transfusing two units of whole blood instead of four units (two red blood cells and two plasma) is feasible and leads to better outcomes for patients.