View clinical trials related to Trauma.
Filter by: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.
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
The aim of the study is to describe the feasibility, cultural appropriateness, and acceptability of Trauma-informed Cognitive Behaviour Therapy (TiCBT) to promote community healing and encourage the reintegration of repentant terrorists and their families to avoid reoffending.
Traumatic injury and inadequate follow-up care are a significant cause of morbidity and 10% of all deaths in sub-Saharan Africa (SSA). In Cameroon, ~50% of all emergency department (ED) visits are due to traumatic injury, which is likely only ~60% of all traumatic injuries. In the subset of patients who seek care, follow-up after discharge can save lives, yet is uncommon due to both supply-side (e.g., under-resourced health systems, poor data) and demand-side (e.g., poverty) barriers, resulting in preventable complications after discharge (e.g., sepsis, osteomyelitis). Consequently, better follow-up care of trauma patients is a neglected, but high-yield opportunity to improve injury outcomes, especially when coupled with mobile health technologies (mHealth) to better predict and implement post-discharge care, preventing disability and death. Thus, in this study, the investigators will scale up an existing trauma registry and expand use of a mHealth screening tool (triage tool). At 10 hospitals, the investigators will implement a trauma registry and mHealth tool and evaluate success in a mixed-methods study; a quantitative prospective cohort of all eligible injured patients will be followed for 6 months after discharge and an inductive qualitative study.
Purpose of the Research: The primary aim of the proposed study is to conduct a randomized parallel-group 3-arm clinical trial comparing two mechanistically distinct interventions for pathological anxiety - (1) Interoceptive Exposure (IE) utilizing graduated exposure to somatic cues (respiratory, cardiac, vestibular) with the primary aim of reducing fear responding to the presence of interoceptive perturbations; (2) Capnometry-Guided Respiratory Intervention (CGRI) aimed at raising end-tidal CO2 levels thereby lowering hyperventilation-induced respiratory alkalosis and its associated fear-eliciting somatic reactions; and (3) Psycho-education about anxiety and its effects (PsyEd), which will serve as a credible control comparator.
This is a study to validate myStrength's macropersonalization algorithm. Specifically, the study seeks to answer: Does myStrength's macropersonalization algorithm match what a clinician would offer as a diagnosis following an expert assessment? Participants will be treatment-seeking adults, ages 18 to 65, recruited from an evidence-based group psychotherapy practice. Participants will be asked to complete myStrength onboarding and a clinician-conducted initial assessment. Inter-rater reliability will be assessed to determine the consistency between myStrength and clinician in primary focus area of digital program.
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).
Continuous renal replacement therapy is widely used in intensive care medicine, which is known as an alternative therapy to save injured kidney . Anticoagulation is an important part of this therapy. An insufficient anticoagulation would cause a poor curative effect of CRRT. Hemorrhageļ¼heparin-induced thrombocytopenia (HIT), citrate accumulation, acidosis ad filter extra-cost usually happened on anticoagulation during CRRT. Therefore a new effective anticoagulation of CRRT needs to be carried out. Nafamostat Mesylate (NM) is a new anticoagulant. This serine protease inhibitor with broad spectrum can inhibit kinds of enzymes on the process of coagulation. NM is mainly rapidly decomposed in the liver and also removed by dialysis or filtration. The elimination half life of is only 8 minutes. If NM is applied as a regional anticoagulant, approximate 40% NM is removed by dialysis and / or convection in cardiopulmonary bypass circuit, and then rapidly degraded by esterase in liver and blood, which ensures security in patients with bleeding tendency. Based on the information above, the investigators designed an observational clinical study aimed to testify that NM would have equivalent anticoagulant results compared with those traditional ways and might even have a better effect than traditional anticoagulant therapy.The study team has investigated the current situation of CRRT in Shaanxi province in China through a cross-sectional survey last year. The survey involved 74 hospitals in Shaanxi province and the results basically illustrated a real status of CRRT. These scientific results helped investigators to design this multi-center, parallel, controlled, non intervention study and real world study.
This is a prospective, single-center, controlled, open label, trial randomized in two parallel groups designed to assess the Quantra QStat System in trauma patients.
Disaster medical teams are formed by hospitals in response to the manpower needs of a large number of injured and sick patients. The current planning of hospitals for a large number of disaster medical manpower is too superficial. The application of today's inspection methods in the treatment of a large number of injured patients is not as good as it is. Therefore, understanding the scene situation has become the key point of manpower deployment. Today's internet transmission speed and computer artificial intelligence technology are very different from 9 years ago. The investigators adopt one more simple and easy-to-operate inspection method and use artificial intelligence technology to assist.