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97 active trials for Trauma

Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study

The loss of muscle mass post-surgery confounds recovery efforts and leads to a delay in patient's ability to return to activities. Although the use of testosterone in aging and chronic muscle loss has been investigated, this study could prove short-term use of testosterone efficacious in preventing muscle atrophy due to surgery. We hypothesize that by bracketing an indexed knee surgery with testosterone undecanoate injections, post-surgical quadriceps muscle loss may be minimized. Determination of the effect of intra-muscular (IM) testosterone injections in preventing quadriceps muscle loss are measured by serial MRI and manual measurements of quadriceps cross-section.

Start: May 2020

Experiential Training in Eliciting Disclosure & Emotions for Mental Health Trainees

Many people seek psychotherapy to alleviate symptoms related to trauma and stressful conflicts, and many psychotherapy approaches aim to help people process trauma and conflicts through eliciting client disclosure of these experiences and activating related emotions. However, many therapists avoid implementing such approaches because they are emotionally challenging for both the client and the therapist, and because therapists lack direct training in specific skills related to eliciting client disclosure and working with emotions. This suggests that providing therapists with a training experience that is experiential, includes direct supervision and feedback, and addresses therapists' reservations and anxieties may be an important approach to increase therapist skills in disclosure elicitation and emotional activation. This is a randomized trial that will test two methods of training (experiential vs. standard) of master's level psychotherapy students in specific therapeutic skills aimed at increasing trainees' emotional awareness and self-regulation and reducing trainee anxiety and avoidance of eliciting disclosure and working with emotions in psychotherapy. In the standard training condition, the trainee will receive a lecture about the skills including rationale and research background, examples, and opportunities to ask questions. In the experiential training condition, the trainees will receive information about the skills with examples and will have opportunity to practice using short video clips of actors portraying clients. The trainees will be asked to respond to the short clips using the skills they learned, and a trainer will process the trainees' reactions after they respond to each practice video clip and will provide feedback to the trainees about their performance on the practice. Findings from this study will provide information about the feasibility of training in specific disclosure elicitation and emotional activation therapy skills, and will provide information about whether or not live supervision will lead to greater improvement in the targeted skills compared to entirely standard training.

Start: December 2020

Effect of Progressive Early Mobilization in Patients With Trauma

The overall goals of this proposed research are (1) to investigate the feasibility of a structured and interdisciplinary progressive EM protocol for critically ill patients with trauma in a trauma ICU and (2) to determine the effectiveness of the progressive EM protocol, which is designed for implementation with trauma patients.

Start: March 2021

Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

The purpose of the study is to test the efficacy of sleep treatment in human patients following traumatic injury. Specifically, the study will determine if treatment consisting of melatonin and education related to sleep habits are effective in treating sleep disturbance and improving sleep quality in Orthopaedic trauma patients. We hope to learn if melatonin and sleep education effectively improve sleep following traumatic injury, and improve outcomes.

Start: January 2019

Lovenox 30 mg Twice Daily (BID) Versus 40 mg Once Daily (QD)

The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many times enoxaparin (or Lovenox) is given to patients who are at a higher risk of developing clots in their legs or lungs. There are two standard doses of enoxaparin that are recommended by the drug companies. These two doses have never been directly compared in trauma, general, and vascular surgery patients. The purposes of this study are: to compare the development of blood clots in patients receiving 30mg twice daily of enoxaparin compared to patients receiving 40mg once daily of enoxaparin. to determine if there is higher risk of bleeding complications in patients receiving 30mg twice daily of enoxaparin compared to patients receiving 40mg once daily. Patients enrolled into the study will be randomized to receive enoxaparin, 30mg twice daily or enoxaparin, 40mg once daily. Patients will then be monitored for signs and symptoms of blood clots. At the time of discharge (or before, if medically indicated), an ultrasound test will be performed to look for blood clots in the patient's legs. The investigators will compare incidence of blood clots formed between the 2 groups of patients to determine if one dose of enoxaparin relates to a lower rate of blood clots in critically ill patients. The investigators will also compare the incidence of bleeding complications between the 2 groups.

Start: February 2014

Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma

This study evaluates the use of the Human Acellular Vessel (HAV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery. There will be a torso cohort and a limb cohort. All subjects will be implanted with a HAV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.

Start: September 2018

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.

Start: July 2018

PMCF Neo Pedicle Screw and Cage Systems

The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.

Start: October 2019

The Resilient Minds Program in Fire Departments

The purpose of the study is to assess the impact of a mental health training program in volunteer and career firefighters.

Start: January 2018

Role of Active Deresuscitation After Resuscitation-2

RADAR-2 will be a randomised, open-label, allocation concealed, pilot trial of conservative fluid administration and deresuscitation compared with usual care in patients who are critically ill.

Start: April 2018

Magnesium Infusion for Pain Management in Critically Ill Trauma Patients

Magnesium is a naturally occurring mineral that is important for your body and brain. Magnesium sulfate (study drug) is a medication containing magnesium that is commonly used to improve low blood levels of magnesium. Magnesium sulfate has also proven to be successful in managing pain before and after surgery. However, this drug has primarily been used for pain control in patients undergoing surgery. Patients in the ICU with injuries also need good pain control. Using magnesium may assist in decreasing narcotic (pain reliever) requirements and provide another non-narcotic drug for pain control. The purpose of this study is to test the effectiveness of continuous, intravenous (into or within a vein using a needle) administration of magnesium sulfate for pain control in trauma patients admitted to the adult Intensive Care Unit. This will be compared to intravenous normal saline (salt solution).

Start: December 2019

Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

The objective of this study is to conduct an observational pre/post study to evaluate the clinical impact oxygen guideline implementation on oxygen utilization and oxygenation in critically ill trauma patients.

Start: January 2019

Beta Blocker Use In Traumatic Brain Injury Based On The High-Sensitive Troponin T Status

Beta blockers (BB) play an important role in protection of end organs that are susceptible for secondary injury by the Traumatic brain injury (TBI)-induced catecholamine surge. However, use of BBs in trauma patients is not yet the standard of care which necessitates clear scientific evidence and justification to be used especially in TBI patients. The BBTBBT study aims to determine whether early administration of propranolol based on the HSTnT status will improve the outcome of mild-to-severe TBI patients. Our primary hypothesis is that BBs are effective in reducing 10 and 30-day mortality in TBI patients.BBs are effective in reducing 10 and 30-day mortality in TBI patients. Methods/Design: The BBTBBT study is a prospective, randomized, double-blinded, placebo-controlled trial, three-arm trial of BB use in mild-to-severe TBI patients based on the HsTnT status.

Start: December 2020

SMART-DAPPER: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research Project

Despite carrying the vast majority of the global mental disorder burden, 75% of adults with mental disorders in Low and Middle Income Countries have no access to services. This study will test strategies for integrating first and second line evidence-based depression and trauma-related disorder treatments with primary care services at a large public sector hospital and conduct robust cost and cost-benefit analyses of each treatment to produce a "menu" of cost-benefit options for personalized, integrated mental health care with corresponding effectiveness and implementation values.

Start: August 2020

Evaluation of a Transfusion Therapy Using Whole Blood in the Management of Coagulopathy in Patients With Acute Traumatic Hemorrhage

The prognosis of traumatized hemorrhages is correlated with the nature of transfusion therapy: a 50% reduction in mortality for an early and massive supply of plasma, and 20% for an early and massive supply of platelets. However, this strategy encounters logistical difficulties, particularly in a context of collective emergency (attacks). The use of whole blood, widely documented by the Armed Forces, improves the availability of plasma and platelets, and simplifies handling by the various actors in the chain. T-STORHM is a randomized, controlled, parallel clinical trial.This study tests non-inferiority of whole blood transfusion therapy in the management of coagulopathy in patients with acute traumatic hemorrhage.

Start: June 2021

PREVENTion of Clot in Orthopaedic Trauma

The purpose of this study is to compare aspirin versus low-molecular weight heparin (LMWH) (Enoxaparin) as a thromboprophylaxis in patients who sustain a fracture.

Start: April 2017

Remote Delivery of a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories of Trauma

This single case series feasibility study is designed to investigate the feasibility of remote recruitment and delivery of a brief visuospatial interference intervention for decreasing the number of intrusive memories of trauma among trauma-exposed women in Iceland. The current study is an extension on two studies already preregistered (NCT04209283 and NCT04342416) that included some aspects of in-person recruitment and/or intervention delivery (rather than fully remote as we aim for here). The intervention is a simple cognitive task (a memory cue followed by playing the computer game "Tetris") with accompanying information. A within-subjects multiple baseline AB design is used, in that the length of baseline ('A'; no intervention) and intervention ('B') phases vary within-subjects across individual intrusive trauma memories. Participants will aim to complete at least one week of the baseline ('A') phase followed by at least two intervention sessions with a researcher remotely (via telephone or secure video platform). Intervention sessions comprise the simple cognitive task alongside accompanying information presented in the form of brief animated videos (e.g., explaining the target symptom). Participants are instructed that they may continue using the technique self-guided in subsequent weeks, and they may opt for additional intervention sessions with remote researcher support (maximum 6 intervention sessions). Participants will be asked to monitor the occurrence of intrusive memories of trauma in a daily diary. It is predicted that participants will report fewer total intrusive memories in the fifth week after the second intervention session (primary outcome) compared to in the first baseline week. The investigators will also explore whether the frequency of targeted intrusive memories is going to decrease relative to non-targeted intrusive memories. Furthermore, the investigators will explore whether having fewer intrusive memories is related to functioning and/or PTSD, depressive or anxiety symptoms.

Start: January 2021

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): PTSD: Women who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for PTSD Trauma-Exposed (TC): Women matched for age and trauma exposure severity but without PTSD 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.

Start: November 2019

Comparison of Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients

In trauma patients with high shock index, the investigators compare the effects on hemodynamics between ketamine and etomidate.

Start: October 2019

Pregabalin vs. Gabapentin on Reducing Opioid Usage

This is a single-center, randomized, open-label, Phase 4 clinical trial investigating the efficacy of multiple-dose administrations of Pregabalin or Gabapentin in combination with traditional opioid pain medications to decrease the amount of opioid pain medication usage in single-system orthopedic trauma patients.

Start: February 2021