Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma
Multiple TraumaRespiratory Distress Syndrome1 moreSevere hypoxemia following trauma may happen in many circumstances (aspiration, ventilation-associated pneumonia, lung contusion...), most of which are not exclusively associated with a direct injury to the lungs. Severe trauma and associated musculoskeletal injuries result in the acute release of Damage-Associated Molecular Patterns (DAMPs) in plasma, many of which are made of nucleic acids. DAMPs then bind leukocytes and trigger NETosis (Neutrophil Extracellular Traps), the release of nuclear material coated with proteolytic enzymes, which ultimately promotes remote lung injury and acute respiratory distress syndrome (ARDS). Considering that many DAMPs and all NETs are made of nucleic acids, we hypothesize that dornase alfa, a commercially available recombinant desoxyribonuclease (DNAse) could reduce DAMPs and NETs-induced lung injury in severe trauma patients under mechanical ventilation in the intensive care unit (ICU). The primary objective is to demonstrate a reduction in the incidence of moderate to severe ARDS in severe trauma patients during the first seven ICU days from 45% to 30% by providing aerosolized dornase alfa once during the first two consecutive ICU days and compared to equivalent provision of placebo (NaCl 0,9%). The secondary objectives are to demonstrate, by using aerosolized dornase alfa compared to placebo: an improvement in static lung compliance a reduction in mechanical ventilation duration / an increase in ventilation-free ICU days a reduction in the length of ICU stay a reduction in the hospital length of stay a reduction in multi-organ failure a reduction in ventilator-associated pneumonia (VAP) a reduction in mortality at day 28
DSUVIA Early Evaluation of Pain Trial
Traumatic InjuryRandomized, interventional trial of Emergency Department (ED) administration of DSUVIA (sufentanil) versus standard care pain management comparing pain treatment outcomes in injured patients with moderate to severe pain
MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response...
TraumaAdult Stem CellsSingle center, prospective, randomized, double-blind, pragmatic Phase 2 clinical study in severely injured trauma patients within hours of hospitalization who have survived initial resuscitation.
Blood Flow Restriction Training After Patellar INStability
Patellar DislocationKnee Injuries2 moreThis research study is designed to allow health care professionals and researchers to answer many questions about whether a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery for those with patellar instability.
Direct Resuscitation of the Open Peritoneum
Wound; AbdomenAbdomen2 moreThe DROP trial evaluates two ways of treating patients whose abdomens are left open after their abdominal surgery. The current standard of care at Sanford is for patients to have their wound covered with a sterile dressing connected to a vacuum with suction, which removes fluid from the abdomen. In this trial, we are evaluating the benefits of adding dialysis fluid to the abdomen periodically, prior to suctioning it out with the vacuum system. This trial will show if the addition of this fluid lowers the risk of complications and death, and allows the surgeon to close the abdomen sooner
Efficacy of SynEx Wound Rinse in Civilian Surrogates of Combat Injury Wounds
Wound HealThe purpose of this interventional study is to compare SynEx Wound Cleanser with the current routine care (Saline) in traumatic wounds. Participants with gunshot, penetrating or burn wounds who participate will be asked to attend up to four study visits, use the assigned wound cleanser and complete brief surveys about their healing and well-being related to the wound healing.
High Intensity Step Training After Traumatic Brain Injury
Traumatic Brain InjuryThis study will explore whether the types and intensity of the interventions being delivered will yield measurable cognitive benefits in addition to improved mobility and balance. The study evaluates three therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI): Conventional Gait and Balance Training, high intensity step training, and high intensity step training with virtual reality.
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical...
Acute Kidney InjuryThis randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT) when compared to CKRT alone (standard of care). This study is further intended to determine whether SCD therapy will reduce the duration of maintenance dialysis secondary to AKI. This study will enroll approximately 200 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.
Erector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal...
SepsisAcute Gastrointestinal Injury1 moreThis study is a prospective, multicenter, parallel-group, open-label, randomized controlled clinical trial. Sepsis is defined as organ dysfunction induced by infections. And sepsis and gastrointestinal injury can be the leading cause for each other. Our previous study showed erector spinae plane block improved the organ dysfunctions in patients with AGI. The aim of the clinical trial is to investigate erector pinae plane block improves the organ dysfunction in septic patients with acute gastrointestinal injury.
Treating Civilian Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation...
Traumatic Brain InjuryWord Finding Difficulty2 moreThe purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., pre-supplementary motor area) thought to aid in memory will improve verbal retrieval in civilian (non-military, non-veteran) participants with histories of traumatic brain injuries. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition, concussion history, structural brain imaging, and EEG predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.