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Completed Studies
PI: Jeremy Cannon, MD
Division of Traumatology, Surgical Critical Care and Emergency Surgery, Department of Surgery
Linking Investigations in Trauma and Emergency Services (LITES) Task Order 2: Shock, Whole Blood and Assessment of TBI (SWAT)
A multicenter, prospective observational study designed to determine the impact of whole blood resuscitation in trauma patients with hemorrhagic shock at risk of large volume resuscitation with and without TBI.
PI: Jeremy Cannon, MD
Division of Traumatology, Surgical Critical Care and Emergency Surgery, Department of Surgery
Percutaneous Catheter Thoracostomy with Irrigation for Traumatic Hemothorax Management and Mechanical Characterization of the Hemothorax Clot
This study collects biochemical and clinical data from patients with TBI in an effort to improve classification of TBI, permit appropriate selection and stratification of patients for clinical trials, and contribute to the development of a new taxonomy for TBI.
PI: Jeremy Cannon, MD
Division of Traumatology, Surgical Critical Care and Emergency Surgery, Department of Surgery
Decision Support for Damage Control Resuscitation (DCR)
A small-scale pilot study to evaluate the feasibility of the Damage Control Resuscitation (DCR) device in guiding resuscitative measures in patients with traumatic injury and significant acute hemorrhage.
PI: Niels Martin, MD
Division of Traumatology, Surgical Critical Care and Emergency Surgery, Department of Surgery
AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections (ACCUTE)
A phase III, randomized, double-blind, placebo-controlled, parallel-group, study of AB103 as compared to placebo in patients with necrotizing soft tissue infections (NSTI).
PI: Niels Martin, MD
Division of Traumatology, Surgical Critical Care, and Emergency Surgery
Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Require Urgent Surgery (ANNEXA-S)
A Phase 2 multicenter, prospective, open-label, proof-of-concept study of the reversal agent andexanet alfa. This study will assess the efficacy and safety of andexanet alfa in patients who require urgent surgery and received some oral anticoagulant within 15 hours prior to surgery.
PI: Niels Martin, MD
Division of Traumatology, Surgical Critical Care and Emergency Surgery, Department of Surgery
ATB-203
A phase II, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of Reltecimod as compared to placebo in addition to standard of care in patients with sepsis-associated acute kidney injury (SA-AKI).
PI: Joseph J DuBose, MD, Megan L Brenner, MD, MSD, Jeremy Cannon, MD
Division of Traumatology, Surgical Critical Care and Emergency Surgery, Department of Surgery
The AURORA Study- Longitudinal Assessment of Post-traumatic Syndromes
A prospective multi-center observational study designed to improve the understanding, prevention and treatment of posttraumatic neuropsychiatric sequelae.
PI: Carrie Sims, MD, PhD
Division of Traumatology, Surgical Critical Care and Emergency Surgery, Department of Surgery
Basis: Evaluating Sirtuin Supplements to Benefit Elderly Trauma Patients (BES2T-BET)
A phase I, randomized, double-blind, placebo-controlled, single institutional pilot trial investigating the impact of nicotinamide riboside/ pterostilbene (BasisTM) on functional recovery after traumatic fall in elderly patients.
PI: Carrie Sims, MD, PhD
Division of Traumatology, Surgical Critical Care and Emergency Surgery, Department of Surgery
Evaluation of Hemostatic Thrombus Formation
A prospective descriptive study investigating the morphological features of platelets and hemostatic plugs using a small vascular injury model in humans undergoing elective bowel resection surgery.
PI: Mark Seamon, MD
Department of Traumatology, Surgical Critical Care and Emergency Surgery
A Phase 2 Study for the Evaluation of Safety and Efficacy of Humacyte’s Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients with Life or Limb-threatening Vascular Trauma
This is a prospective, multicenter, multi cohort, non-randomized Phase 2 study evaluating the efficacy of the Humacyte Human Acellular Vessel (HAV) in adult patients with life or limb threatening vascular trauma which requires surgical repair.
PI: Michael Shashaty, MD, MSCE
Department of Medicine
Necroptosis and Cell-Free DNA in the Pathogenesis of Organ Dysfunction After Trauma
A prospective observational study to determine if necroptosis and consequent plasma damage-associated molecular pattern (DAMP) release plays an early pathophysiologic role in the development of AKI and ARDS in trauma patients.
PI: Daniel N Holena, MD
Division of Traumatology, Surgical Critical Care and Emergency Surgery, Department of Surgery
The Normative Emergency Department Thoracotomy: Use of Video Review for Procedural Benchmarking
A retrospective observational study conducting methods-comparison to determine if data collected from abstraction of audiovisual recordings is superior to established methods of data collection currently in use for emergency thoracotomy procedures.
PI: Sunil Singai, MD
Surgery, Department of Thoracic Surgery
Precision Surgery – Solid Tumor Cancer Surgery Registry, Sub Study with ICG
The purpose of the cancer surgery register is to monitor the rate of reoccurrence in patients who undergo cancer surgery. The purpose of the optional sub-study is to estimate the sensitivity of ICG uptake and expression in identifying solid tumors/masses, margins, lymph nodes and satellite tumors when excited by an imaging probe in the operating room.
PI: Niels Martin, MD
Division of Traumatology, Surgical Critical Care and Emergency Surgery, Department of Surgery
Asahi Kasei SCARLET Sepsis Study
A randomized, double-blind, placebo-controlled, phase III study to assess the safety and efficacy of ART-123 in subjects with severe sepsis and coagulopathy.
PI: Carrie Sims, MD, PhD
Trauma Surgery - Division of Traumatology, Surgical Critical Care and Emergency Surgery, Department of Surgery
Trauma Induced Coagulopathy and Inflammation (TrICI) Trial
A prospective observational study designed to evaluate the factors that contribute to the development of trauma induced coagulopathy (TIC), post injury inflammation and organ dysfunction in adult trauma patients in order to develop a multi scale computational algorithm and ex vivo models capable of clinical prediction.
PI: Benjamin S. Abella, MD MPhil
Department of Emergency Medicine
Exosomal Markers of Brain Injury After Cardiac Arrest
A prospective cohort study to quantify neurologic injury and characterize neuronal injury patterns among out-of-hospital cardiac arrest patients at 4 acute time points following return of spontaneous circulation (ROSC)
PI: David Jang, MD, MSc; John Greenwood, MD
Department of Emergency Medicine
Alterations in Mitochondrial Bioenergetics and Dynamics in Blood Cells Obtained from Emergency Department Patients with Sepsis
A prospective observational study aims to explore the logistics of measuring mitochondrial respiration that fits in an analytical timeframe to identify clinical abnormalities or to help guide therapy as well as evaluate changes in mitochondrial bioenergetic function (respiration and ROS) and dynamics (movement, localization, and rates of fission/fusion events).
PI: Benjamin Abella, MD, MPhil
Department of Emergency Medicine
Observational Convenience Sample Study of Mechanical CPR in the Medical Intensive Care Unit
A pilot study testing the feasibility and utility of mechanical CPR in cardiac arrest patients using the LUCAS device in the Medical Intensive Care Unit (MICU).
PI: Jill Baren, MD
Department of Emergency Medicine
Established Status Epilepticus Treatment Trial (ESETT)
A multicenter, randomized, double-blind, comparative effectiveness study of fos-phenytoin(FOS), levetiracetam (LEV) and valproic acid (VPA) in subjects with benzodiazepine-refractory status epilepticus (SE).
PI: Danielle Sandsmark, MD, PhD
Department of Neurology
The Natural History of Endothelial Progenitor Cell Mobilization and Cerebral Microvascular Injury
A prospective observational study to examine the natural history of EPC mobilization and neuroimaging markers of traumatic vascular injury in the acute, subacute and chronic stages after TBI.
PI: Josh Levine, MD
Department of Neurology
SAGE-547
A randomized, double-blind, placebo-controlled study to evaluate the efficacy of SAGE-547 Injection in the treatment of subjects with Super-Refractory Status Epilepticus.
PI: Ramon Diaz-Arrastia, MD, PhD
Salivary Biomarkers in Traumatic Brain Injury
A prospective, observational study aimed at collected biological fluids from TBI and healthy subjects to elucidate biomarkers for TBI.
PI: Ramon Diaz-Arrastia, MD, PhD
Department of Neurology
Head Injury Serum Markers and Multi-Modalities for Assessing Response To Trauma (HeadSMART II)
The goal of this study is to develop an In-Vitro Diagnostic, the BRAINBox TBI Test, to aid in the diagnosis and prognosis of patients with mild Traumatic Brain Injury (TBI) by incorporating blood biomarkers, clinical assessments, and tools to measure associated neurocognitive impairments.
PI: Ramon Diaz-Arrastia, MD, PhD
Department of Neurology
Clinical Evaluation of the i-STAT Traumatic Brain Injury Test
This study evaluates the ability of the i-STAT blood test to detect acute biomarkers of traumatic brain injury (TBI).
PI: Ramon Diaz-Arrastia, MD, PhD
Department of Neurology
Penn Acute Research Collaborative – Traumatic Brain Injury
This study collects biochemical and clinical data from patients with TBI in an effort to improve classification of TBI, permit appropriate selection and stratification of patients for clinical trials, and contribute to the development of a new taxonomy for TBI.
PI: Adam Cuker, MD
Department of Medicine
Phase 2, Randomized Study of the Tolerability and Safety of the OsciPulse Device for the Prevention of Venous Thromboembolism (VTE)
This study aims to assess the tolerability and hemodynamic impact of the OsciPulse device on venous blood flow in an inpatient setting.
PI: Ravi Amaravadi, MD; Benjamin Abella, MD; Ian Frank, MD
COVID-19 Prevention and Treatment with HCQ: A 3-arm randomized trial of hydroxychloroquine in the prevention and treatment of COVID-19
A randomized controlled study of the efficacy of hydroxychloroquine in treating home quarantined COVID-19 patients and the prevention of COVID-19 infection in Penn Medicine fulltime health care workers.
PI: Cynthia Otto, DVM, PhD
School of Veterinary Medicine
Can Detection Dogs Serve as a Tool to Screen Outpatients for COVID-19?
This study evaluates whether dogs can be trained to detect COVID-19 from sweat and bodily odors. T-shirts collected from both infected and uninfected individuals allow dogs to discriminate between the sources.
PI: Benjamin Abella, MD, MPhil
Department of Emergency Medicine
Feasibility Testing of a New COVID-19 Testing Platform
This study assesses the feasibility of a novel COVID-19 testing platform which utilizes electrochemistry technology to quickly and reliably determine the presence of COVID-19 infection.
PI: Benjamin Abella, MD, MPhil
Department of Emergency Medicine
A Multicenter Study Conducted to Evaluate the Performance of the Homodeus COVID DETECT at Point of Care Testing Sites
A multi-site study to evaluate the performance of a novel COVID19 PCR assay system in detecting SARS-CoV-2 in anterior nares swab specimens from patients with signs and symptoms of Covid-19 illness.
PI: Peyman Zamani, MD, MTR
Department of Medicine
Peripheral Determinants of Exercise Capacity in HFpEF: Focus on Skeletal Muscle Mitochondria and Capillaries
A prospective study analyzing impaired mechanisms which regulate vascular resistance, redistribution of blood flow toward exercising tissue, diffusion of oxygen from the capillary bed to the mitochondria, and skeletal muscle mitochondrial function and contribute to exercise intolerance in HF patients.
PI: Mark Kahn, MD
Venous Valve Endothelium and DVT
An investigation of the mechanisms regulating endothelial expression of thrombosis-related proteins and how this regulation impacts deep vein thrombosis.
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