Clinical Research Directory

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.

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.

Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures

An open reduction and internal fixation is a painful procedure requiring intensive postoperative pain management. Traditionally, opioid analgesia has been the gold standard for postoperative pain control. However, given the harmful side effect profile and opioid epidemic in the United States, it is advantageous to use alternate forms of analgesia. Multimodal pain control captures the effectiveness of different analgesic modalities and maximizes analgesia while minimizing side effects. The theory behind their use is that agents with different mechanisms of action work synergistically in preventing acute pain. Objective: To measure postoperative pain control in patients in two treatment arms of ORIF of the clavicle: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen. Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All adult patients scheduled for an ORIF following a traumatic fracture by fellowship trained Trauma surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to Motrin, Lyrica, Tylenol, Zanaflex, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. On the day of surgery, patients will be randomized to receive a nonopioid pain control regimen or an opioid regimen using a computer-generated sequence. If pain is uncontrolled, patients will also be sent home with a prescription with 10 pills of 5 mg of Oxycodone for breakthrough pain. The amount of oxycodone taken will be recorded. Patients can call the resident on call, available 24-hours per day, if additional pain control is needed. Treatment: All patients will undergo previously scheduled ORIF of the clavicle in standard fashion and be randomized to the non-narcotic pain regimen vs the narcotic pain regimen.

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.

Evaluation of Transthoracic Echocardiography Parameters and Their Changes in Blood Donor Volunteers

This study investigates the impact of blood donation on transthoracic echocardiography (TTE) parameters in healthy volunteers, aiming to enhance the understanding of hemodynamic changes associated with mild blood loss and assess non-invasive monitoring techniques for early hemorrhage detection. Conducted as a prospective, interventional study with minimal risk, this research is designed to simulate a controlled hemorrhage in a civilian setting, using voluntary blood donation as a model to study the physiological effects of blood loss of approximately 6 mL/kg. Rationale and Background Hemorrhagic shock is a leading cause of preventable death in trauma patients, particularly among younger populations. The ability to rapidly detect and quantify blood loss is crucial in trauma management, as delayed or excessive resuscitation can lead to adverse outcomes, including multi-organ failure and coagulopathy. Traditional methods of monitoring blood volume and cardiac output, such as invasive catheterization or imaging techniques like CT scans, may not be feasible or practical in prehospital settings. TTE, particularly the measurement of the aortic time-velocity integral (TVI) using Doppler echocardiography, presents a non-invasive and potentially valuable tool for assessing cardiac output and detecting early hemodynamic changes due to blood loss. Primary Objective The primary objective of this study is to evaluate whether the aortic TVI decreases by at least 10% following a controlled blood volume reduction during blood donation. This decrease in TVI could serve as a reliable marker of reduced cardiac output and might allow clinicians to detect mild to moderate blood loss in trauma patients non-invasively. Secondary Objectives The study also aims to examine additional echocardiographic parameters that may indicate changes in hemodynamic status following blood loss. Secondary objectives include measuring changes in: Shock index (SI), calculated as the ratio of heart rate to systolic blood pressure, a parameter often associated with hypovolemia. E-wave and e'-wave velocities, which reflect left ventricular filling pressures and diastolic function. Ratios of E/e' and E/A, which are indicative of left ventricular diastolic function and filling pressures. Global longitudinal strain of the left ventricle (GLS), which represents myocardial contractility. Methods Healthy adult volunteers meeting eligibility criteria for blood donation are recruited from local blood donation centers. Participants undergo baseline TTE to measure the aortic TVI, E-wave, e'-wave, and other relevant parameters before donation. Following a blood donation procedure of approximately 450 mL (representing a 6 mL/kg blood loss for the average volunteer), TTE is repeated immediately after donation and then 15 minutes post-donation to capture any transient changes in cardiac output and ventricular function. Volunteers receive structured hydration and are observed for any adverse events. Outcome Measures The primary outcome measure is a decrease of at least 10% in aortic TVI from baseline immediately following blood donation, which would confirm the sensitivity of TTE to detect mild hypovolemia. Secondary outcome measures include changes in the shock index, variations in Doppler-derived E and e' waves, and the E/e' and E/A ratios, assessed immediately and 15 minutes post-donation. The study will also monitor the global longitudinal strain (GLS) as an additional measure of left ventricular performance. Statistical Analysis The required sample size was calculated to detect a 10% decrease in TVI with 90% power at a 5% significance level, resulting in a target enrollment of 66 participants. Descriptive statistics will be used for continuous variables, expressed as mean ± standard deviation or median and interquartile range as appropriate. Paired t-tests or Wilcoxon signed-rank tests will assess changes in parameters before and after blood donation. Each participant's response will be classified as positive if a decrease of at least 10% in TVI is observed, or negative if the decrease is below this threshold. Potential Impact If successful, this study could validate the use of TTE-derived parameters, such as aortic TVI and shock index, as non-invasive markers for early detection of blood loss in trauma patients. By providing real-time insight into hemodynamic changes, this approach could improve decision-making in prehospital and emergency settings, allowing clinicians to tailor resuscitation strategies based on the actual volume of blood loss. This could reduce the risks associated with both under-resuscitation and over-resuscitation, ultimately improving patient outcomes.

CytOSorb TreatMent Of Critically Ill PatientS Registry

Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care

Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System

The purpose of the study is to assess screw deviation from pre-planned trajectory using the Mazor X robotic system in patients undergoing posterior thoracolumbar arthrodesis procedures between T2-S1.

Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen

The purpose of the study is to find out the incidence of trauma induced coagulopathy in patients with severe trauma who received fibrinogen prior admission to emergency department during prehospital care.

Mobile and Web-Based Healing Program on University Students Affected by Earthquakes

This research is a randomized controlled study that will be conducted in an online environment. The study comprises five stages. The first stage, PREPARATION, involves obtaining ethical approval and permissions from universities, preparing data collection tools, and identifying scholarship recipients. The second stage is the development of the MOBILE AND WEB-BASED application. The third stage is the SITUATION ASSESSMENT stage. In this stage, the post-earthquake trauma level, coping skill level, emotional eating levels, and the status of healthy lifestyle behavior of students enrolled in the Nursing Departments of firat University, Osmaniye Korkut Ata University, and Ankara University will be determined using one of the quantitative data collection tools, PETLDS (Objectives 1, 2, 3, and 4). The fourth stage is the INTERVENTION stage, where the prepared training and applications will be implemented within the program (Objectives 5, 6, 7, and 8). The fifth stage is the EVALUATION stage, involving the collection of final test data and analysis.

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.

Comparative Outcomes of PCC and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion

This study aims to compare the incidence of thromboembolic complications among trauma patients receiving PCC, rFVIIa, both agents, or neither during massive transfusion. Secondary objectives include comparing mortality, transfusion requirements, intensive care unit (ICU) and hospital length of stay, ventilator-free days, and the incidence of transfusion-associated adverse events such as transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO). Subgroup analyses will evaluate outcomes in patients with and without laboratory-confirmed TIC (INR \>1.2).

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.

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.

A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients

Hypotheses 1a and 1b: Compared to Supportive Conversation arm, the EMPOWER intervention will significantly decrease surrogate decision makers' symptoms of grief and Post Traumatic Stress Disorder (PTSD) (primary outcomes); and H1b. experiential avoidance, depression, regrets, and increases in patients' value-concordant care (secondary outcomes) at T1-T4. Hypothesis 2. Qualitative data will provide insights not captured by quantitative data. Hypothesis 3. Reductions in experiential avoidance will mediate reductions in grief and Post Traumatic Stress Disorder (PTSD) symptoms, highlighting it as important to target in future implementation.

Splenic Embolisation Decisions

The spleen is often injured when the body sustains trauma. This leads to bleeding. The bleeding can be stopped by a big operation cutting open the belly or a small hole in your groin where a blood vessel can be accessed and through which the bleeding can be stopped. We do not know what types of injuries it is best to use this procedure. We do not know why we do not use the smaller technique in some instances. We also do not know exactly which of a number of ways to stop the bleeding could be better. We have a big data set in the trauma and audit research network (TARN) which we would like to use to help answer these questions and design further studies to better answer the questions. Adding a few other pieces of data, we are able to answer key questions into how the spleen will best be treated in trauma.

Pain as Indication for Operative Treatment of Traumatic Rib Fractures

The purpose of this prospective randomized controlled study is to determine whether acute and chronic pain in patients who suffer multiple traumatic rib fractures is decreased after surgical management as compared to conservative management.

Comparative Effectiveness of SPARCS and Unified Protocol for Youth With Chronic Medical Conditions and Trauma-Related Distress

The goal of this clinical trial is to compare the effectiveness of trauma-focused therapies for improving mental health symptoms and daily functioning in youth with chronic medical conditions who have experienced psychological trauma and trauma-related distress. The study evaluates two evidence-based cognitive-behavioral therapies - Structured Psychotherapy for Adolescents Responding to Chronic Stress (SPARCS) and the Unified Protocol (UP) - delivered in group and individual formats to determine which approach, or combination of approaches, best reduces trauma symptoms and supports coping and adjustment. The study will also help researchers understand how to best support youth who continue to experience distress after an initial round of therapy. The main questions it aims to answer are: * Does SPARCS group therapy or UP group therapy lead to greater improvements in trauma symptoms and functional impairment? * For youth who do not show enough improvement after group therapy, does adding SPARCS or UP individual therapy lead to better outcomes? * Which sequence of group and individual therapies leads to the greatest improvements in trauma symptoms and functioning? Researchers will compare two evidence-based therapies currently offered at Ann \& Robert H. Lurie Children's Hospital of Chicago. Youth will first be randomly assigned to receive either SPARCS or UP in a group format. After completing group therapy, youth who still need additional support will be randomly assigned again to receive individual or family therapy using SPARCS or UP. This stepwise approach will help identify which sequence of therapies leads to the best overall outcomes for youth. Participants will: * Take part in group therapy sessions using either SPARCS or UP * For those needing additional support after group therapy, participate in individual SPARCS or UP therapy * Complete brief assessments of mental health and daily functioning at enrollment, and every 12 weeks thereafter for 48 weeks, as part of their regular care through Ann \& Robert H. Lurie Children's Supporting Purposeful Interventions \& Resilience in Trauma (SPIRIT) program

Inferior Vena Cava Versus Subclavian Vein Collapsibility for Predicting Fluid Responsiveness in Trauma Hemorrhagic Shock

Hemorrhagic shock from severe bleeding is a leading cause of preventable death in trauma patients. Intravenous (IV) fluid resuscitation is essential for stabilizing blood pressure and organ perfusion, but administering too much or too little fluid can cause severe complications. Only about half of hemodynamically unstable patients show an increase in cardiac output after receiving fluids. Emergency physicians often use bedside ultrasound to measure respiratory changes in the inferior vena cava (IVC), known as the IVC collapsibility index (IVC-CI), to predict whether a patient will benefit from fluids. However, obtaining clear IVC views can be difficult or impossible in trauma patients due to abdominal pain, obesity, or abdominal injuries. Evaluating the subclavian vein (SCV) under the collarbone provides a potential alternative window. The main purpose of this study is to compare the diagnostic accuracy of the subclavian vein collapsibility index (SCV-CI) against the inferior vena cava collapsibility index (IVC-CI) for predicting fluid responsiveness in adult trauma patients presenting with hemorrhagic shock. Eligible adult trauma patients with hemorrhagic shock will undergo rapid bedside point-of-care ultrasound upon presentation to the emergency department. Physicians will measure respiratory diameter variations in both the subclavian vein and inferior vena cava. Patients will then receive a standardized fluid challenge of 10 mL/kg intravenous balanced crystalloid solution over 10 to 15 minutes as part of resuscitation. Fluid responsiveness will be assessed by measuring changes in blood flow through the neck using carotid artery Doppler ultrasound before and 5 to 10 minutes after the fluid challenge. The study will determine whether subclavian vein ultrasound offers comparable diagnostic performance and greater feasibility compared to inferior vena cava ultrasound in emergency trauma resuscitation.

Accuracy and External Validation of mREMS in Road Traffic Injuries

The goal of this prospective observational study is to assess the accuracy and external validation of the Modified Rapid Emergency Medicine Score (mREMS) in predicting outcomes for patients with road traffic injuries (RTIs) admitted to the emergency department of a hospital in Baghdad. The main questions it aims to answer are: How accurate is the mREMS in predicting the prognosis of road traffic injury patients? Does the mREMS provide reliable predictive value in a local context, specifically in Baghdad? Participants will: Be assessed using the mREMS upon admission to the emergency department. Have their clinical outcomes, including mortality, need for surgery, and length of stay, monitored throughout their hospital stay.

Study of Cannabidiol and Neuroimaging on Stress

Dysregulation in stress responsivity is a growing psychiatry-transdiagnostic fundamental phenomenon, with limited therapeutic strategies. With the legalization of medical and recreational cannabis, many people consume cannabidiol (CBD; a nonintoxicating cannabinoid) to alleviate stress response, without the benefit of scientific guidance. To address this gap, the investigators propose a rigorous translational neuroscience study in a clinical high-risk population to define the roles of CBD in stress response with mechanisms of mesocorticolimbic-network function and hierarchy, neurometabolic, endocrine, and behavior, building upon convergent evidence from animal models and human evidence from our laboratories.

Comparing NISS and ISS for Mortality Prediction in Trauma Patients

The goal of this prospective cohort study is to compare the predictive utility of the New Injury Severity Score (NISS) and the Injury Severity Score (ISS) in determining mortality outcomes among trauma patients admitted to emergency rooms (ER) in Iraq. The main questions it aims to answer are: * Does the NISS provide a more accurate prediction of mortality than the ISS? * Are there specific subgroups of trauma patients where one scoring system outperforms the other? Participants will: Be assessed using both the NISS and the ISS upon their ER admission. Have their clinical outcomes, including mortality, monitored throughout their hospital stay.

Fluid Resuscitation Optimization in Surgical Trauma Patients (FROST)

The aim of this study is to determine if the incidence of post-operative complications can be decreased by the implementation of intra-operative, minimally invasive hemodynamic monitoring (MIHM) via FloTrac™ and EV1000™ in trauma patients.

Fibrinogen Early In Severe Trauma StudY II

Annually over 7000 Australians are treated for severe trauma. Haemorrhage secondary to severe trauma is a major cause of potentially preventable death and poor outcomes in Australian adults. Severe trauma may trigger changes in blood clotting mechanisms and factor levels leading to inhibition of clot formation and reduced clot strength. This results in the inability of the severely injured trauma patient to form adequate clots to help stop bleeding. There is good evidence to suggest the loss of clotting factors during haemorrhage is associated with worse outcomes and it is thought the early replacement of these factors may reduce bleeding and improve patient outcomes. Fibrinogen is a key clotting factor that helps bind clots together and early fibrinogen replacement may improve outcomes. Currently fibrinogen is replaced using cryoprecipitate, a blood product made from blood donated by healthy donors which is a precious resource. It can take a significant amount of time to administer as it is frozen and stored in the blood bank. Timely administration of cryoprecipitate is difficult as it requires thawing prior to transfusion. The large doses of cryoprecipitate used in traumatic haemorrhage can put strain on local blood banks in supplying requested units in a timely manner. Additionally, the widely dispersed population of Australia introduces logistic challenges to the maintenance of adequate cryoprecipitate stocks to individual hospital blood banks, especially in remote regions. However, cryoprecipitate contains a number of other coagulation factors (not just fibrinogen) that may be instrumental in clot formation and resistance to fibrinolysis. Fibrinogen concentrate is an alternative product used to assist in blood clotting. It is a dry powder form of fibrinogen and can be reconstituted at the bedside and given quickly. The use of a fibrinogen factor concentrate with a long shelf life that is easy to use has significant implications for both large urban metropolitan areas and remote isolated communities. The timing and mode of fibrinogen replacement in traumatic haemorrhage has implications for patient outcomes, blood product availability, costs and the national blood supply. Despite the importance of fibrinogen replacement in traumatic haemorrhage, there have been no clinical trials powered for clinical outcomes directly comparing fibrinogen concentrate and cryoprecipitate. FEISTY II will evaluate the efficacy, safety and cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate in trauma patients with major haemorrhage. FEISTY II is a phase III randomised trial which will enrol 850 patients from Australian and New Zealand major trauma centres, with a primary patient outcome of days alive out of hospital at day 90 after injury. Severely injured trauma patients who require blood transfusion and have evidence of low fibrinogen levels will be randomised to receive either fibrinogen concentrate or standard care with cryoprecipitate