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Trauma clinical trials

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NCT ID: NCT01475344 Completed - Trauma Clinical Trials

Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)

Start date: September 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Severe traumatized patients with visible significant bleeding and/or with clinical signs of internal significant bleeding treated by an emergency doctor of the helicopter service or the ground team will be enrolled in the study (inclusion- and exclusion criteria: see above). If a patient meets the inclusion criteria and is recruited for the study, FGTW or placebo administrated over 5 min/vial: Body Weight: < 30 kg / 30-60 kg / 60 - 90 kg / > 90 kg No. of vials: 1 vial (100 ml) / 2 vials (200 ml) / 3 vials (300 ml) / 4 vials (400 ml) Fibrinogen (if applicable): 1.5 g / 3 g / 4.5 g / 6 g

NCT ID: NCT01426711 Completed - Sepsis Clinical Trials

Critical Care Excellence in Sepsis and Trauma

CREST
Start date: September 2009
Phase:
Study type: Observational

The care of patients with sepsis and trauma requires the delivery of appropriate definitive care in the early stages of the illness. Hospitals with limited resources, those in rural and underserved areas of South Carolina, may be unable to consistently provide optimal care to these patients. In addition, the shortage of specialists nationally makes it more difficult for these hospitals to recruit and retain the specialists needed. Patients in these areas continue to pay the rural penalty of poorer outcomes. This study provides specialists' level care through telemedicine consults to rural emergency departments in rural areas of SC to improve outcomes for these patients. The CREST study is a project that specifically addresses the need to bring health care to rural communities in SC, as well as evaluates methods and tests technology to implement this care in rural communities. The CREST study uses telemedicine remotely from MUSC to rural community hospitals to provide rural community physicians care from specialists for trauma and sepsis, which are both high acuity, difficult to treat conditions. CREST is a multi-site trial of telemedicine services to meet rural patients' and providers' need for expert evaluation and management of sepsis and trauma. The specific aims of CREST are: 1. To test the hypothesis that a telemedicine program including education and clinical consultation between a tertiary care academic medical center and rural, local hospitals will significantly improve key treatment decisions and outcome measures in sepsis and trauma. 2. To test the hypothesis that the differences in ISS and time to antibiotics for trauma and sepsis patients exposed to telemedicine intervention and those without the intervention matched on propensity scores are not due to unmeasured confounders. CREST seeks new solutions to rural health disparities, to advance technology, create and retain jobs and address important research opportunities by combining implementation of a novel, trans disciplinary clinical program with rigorous, mixed methods scientific evaluation including clinical, process, and economic outcome measures. The impact on both science and quality healthcare outcomes is broad and CREST has far reaching implications for addressing rural health disparities for acute, life-threatening illnesses.

NCT ID: NCT01413984 Completed - Trauma Clinical Trials

Substance Abuse and Trauma in Incarcerated Women

Start date: November 2010
Phase: N/A
Study type: Interventional

The proposed study will evaluate Covington's Helping Women Recover (HWR) plus Beyond Trauma (BT) curriculum with female offenders at Eddie Warrior Correctional Facility in Taft, Oklahoma. The purpose of the proposed study is to expand previous findings by including a comparison group of women that are not receiving treatment but are otherwise eligible, and by using outside evaluators to conduct the assessments. Furthermore, this study will extend the outcomes measured in previous evaluations by including measures of sleep disturbance, posttraumatic cognitions, and a more extensive assessment of trauma-related symptoms. The hypotheses for this study are listed below: 1. Incarcerated women with substance use disorders and history of trauma enrolled in the integrated treatment program (HWR plus BT) will report significantly fewer symptoms on measures of posttraumatic stress and associated cognitions, substance use, depression, and related symptoms following treatment than those in the comparison group. 2. Those in the treatment group will improve significantly more than those in the comparison group on the symptoms listed above.

NCT ID: NCT01405001 Completed - Trauma Clinical Trials

Registry of Emergency Airways Arriving at Combat Hospitals

REACH
Start date: December 2004
Phase: N/A
Study type: Observational

This represents the first prospective examination of advanced airway management under combat conditions. The findings will have a tremendous impact on both modern prehospital medical practice and on the treatment of our wounded Soldiers during the Global War on Terrorism.

NCT ID: NCT01402856 Completed - Trauma Clinical Trials

Teenage Driving Safety Study: An Emergency Medicine-Trauma Collaborative Study

Start date: November 2007
Phase: N/A
Study type: Observational

Teenage driving safety continues to be a major public health issue. Two factors have been found to contribute to a higher teenage driving accident rate than adults: lack of driving experience, and risky behaviors. Insufficient driving experience puts teenagers at a disadvantage in detecting and responding to hazards while driving. Factors contributing to distracted driving (a diversion in the driver's attention from the road) may include: talking or text messaging on a cell phone, applying makeup, having multiple passengers, listening to loud music, eating/drinking, smoking or reading while driving. This is a prospective study designed to evaluate the effect of an educational program on the risks associated with distracted driving for teenage drivers. The researchers will compare cell phone usage behaviors in Pennsylvania, where no cell phone laws are in place, and New Jersey, where cell phone laws exist, and will educate the beginner driver on the potential dangers associated with driving without a seat belt, substance use, and participating in distracting driving behaviors. Knowledge of state laws will also be assessed. Objectives 1. Educate participants on the potential dangers of distracted driving. 2. Evaluate the impact of the educational program on teenage distracted driving behaviors by obtaining and analyzing information from student surveys, state law quizzes, and anonymous observation, pre, post, and delayed post education. 3. Quantify distracted driving behavior in teenage driver's attending local area high schools by obtaining and analyzing information from student surveys, state law quizzes, and anonymous observation, pre, post, and delayed post education. 4. Qualify distracted driving behavior in teenage driver's attending local area high schools by obtaining and analyzing information from student surveys, anonymous observation, and anonymous voicemails, text messages, and/or emails pre, post, and delayed post education. Qualify distracted driving behavior in adults through anonymous observations near local area high schools. 6. Compare teenage driving behaviors as reported and observed between Pennsylvania and New Jersey. 7. Compare seat belt usage, driving behaviors, and substance use in the study population to the state and national averages pre and post education. 8. Compare averages of student's knowledge of state driving laws pre and post education.

NCT ID: NCT01378013 Completed - Breast Cancer Clinical Trials

SurgicAl Metabolic Phenotyping Longitudinal Evaluation Study

SaMPLE
Start date: August 2011
Phase: N/A
Study type: Observational

This work will use a new approach to measure how surgery effects human biochemistry and metabolism. It will create a metabolic signature or 'phenotype' for surgical injury that will help clinicians choose the right surgical treatments for an individual. This is because metabolism is based on an individual's genes, disease burden and environmental influences such as gut microbiota. This study will use a scientific method based on computational analysis of spectra taken from techniques known as Mass Spectrometry (MS) and Nuclear Magnetic Resonance (NMR) spectroscopy. This science is called 'metabonomics' and it has many advantages. Firstly, it provides a measure of thousands of metabolites at a single moment in time that are unique to the individual and it therefore gives a 'systems' overview of a persons metabolism. Secondly it is able to process many hundreds of samples quickly. The investigators are aiming to integrate the investigators metabolic data with genetic information about patients or bacteria wherever possible. This will be the first time that a 'systems biology' approach has been used in surgery, with potentially significant gains to me made in pre operative risk stratification and optimisation. By performing this analysis at all stages of the surgical journey (preoperatively, during the operation and after the surgery) it will ensure the right treatments are given to the right patient at the right time. By creating longitudinal models of the biochemical responses to surgery, predict at a much earlier stage those patients at risk of developing complications. This will improve outcome after surgery. This work will use a metabonomic approach to create new tools for surgeons to use during operations based on tissue biology. For example the investigators will be able to measure the metabolic content of tumours in real time by measuring the biological content of diathermy smoke. This has the potential to change intra-operative decision making and further improve outcome.

NCT ID: NCT01363180 Completed - Trauma Clinical Trials

Stress-induced Drinking in Emerging Adults: the Role of Trauma History

ARC5
Start date: January 1, 2011
Phase:
Study type: Observational

This project is the first to use a clinical laboratory method in emerging adults to test the hypothesis that a trauma history with or without concommitant posttraumatic stress disorder (PTSD) alters response to a stressor and promotes drinking compared to normal controls. The study will be the first to explore whether trauma-exposed (TE) and PTSD groups differ on these outcomes. It will also examine the relationship between stress reactivity and subsequent stress-induced drinking in these samples. The goal of this program is to better understand the relationship between stress and factors related to the development and maintenance of alcohol problems in early adults, so that ultimately, better treatments may be developed that reduce the incidence and severity of alcohol related problems.

NCT ID: NCT01355042 Completed - Sepsis Clinical Trials

Studies of Blood DNA in Patients With Severe Infection DYNAMICS

DYNAMICS
Start date: November 2010
Phase: N/A
Study type: Observational

Severe sepsis (ie. life-threatening infections) is triggered by harmful microorganisms or their toxins in the blood or tissues. These harmful agents damage the lining of blood vessels which can lead to inflammation, blood clot formation, and vessel obstruction. In Canada, there are approximately 90,000 patients with severe sepsis each year. Of these, 30% to 50% will die. The identification of highly reliable outcome predictors in severe sepsis patients is important for several reasons including: to help describe the severity of sepsis, to classify patients for enrollment in clinical studies, and to monitor a patient's response to treatment and procedures. In the investigators lab, the investigators examined the incremental usefulness of adding multiple biomarkers to clinical scoring systems for predicting ICU mortality in patients with severe sepsis. In a preliminary study of 80 patients with sepsis, the investigators found that high levels of plasma DNA predicted ICU death better than any other clinical or biological factor. In this grant, the investigators propose to confirm these findings in an external group of 400 patients in a blinded fashion. The investigators also plan to study how plasma DNA levels change over time and whether high plasma DNA levels can be used to distinguish sepsis from other critically ill conditions. For this the investigators will compare the investigators septic patients to a cohort of 600 patients in the ICU with other conditions. The investigators believe this research has the potential to significantly improve the management and treatment of septic patients.

NCT ID: NCT01339546 Completed - Trauma Clinical Trials

National Trends in Otitis Media in Children Under 5 Years of Age

Start date: June 9, 2010
Phase:
Study type: Observational

The rationale for this study is to assess the change in ambulatory care visit rates for acute otitis media between the period before (2001-2009) and after the introduction of the 13-valent pneumococcal conjugate vaccine (13vPnC) (2011-2013) among children less than 5 years old in the United States.

NCT ID: NCT01338480 Completed - Surgery Clinical Trials

Improving Informed Consent Process for Trauma Patients in the Emergency Department

Start date: November 9, 2009
Phase: N/A
Study type: Interventional

This study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing trauma patients in emergency department (ED) about risks, benefits, and alternatives to receiving surgery.