Research Studies

Ongoing Investigator-Initiated Studies

  • PI: Edward Michelson, MD.

Study Purpose:  Characterize changes in stored whole blood over time, using the Quantra instrument with its sonic estimation of elasticity via resonance (SEER) technology to study stored whole blood preserved with CPDA and extending testing to 35 days. Serum potassium levels will also be assessed at each timepoint as an indicator of red blood cell hemolysis, along with a reproduceable estimate of per cent hemolysis reported on the same instrument.   

Inclusion Exclusion

Age >18 years

Not meeting one or more of the inclusion criteria

Non-pregnant, not taking blood thinners, not taking oral contraceptives

  

In good health at time of consent and blood donation

  

No history of anemia, thrombocytopenia, or coagulopathy

  

No blood bank donation within last 30 days

  

Within the last 7 days, have not taken an anti-platelet medication, aspirin or any other non-steroidal anti-inflammatory drug (NSAID)  

  

  • PI: Edward Michelson, MD
  • Co-PI’s: Kara Samsel, MD

Study Purpose: The Accuro XV is a cart-based ultrasound imaging system that has been designed to acquire images of bone and soft tissue anatomies. The primary clinical application for the Accuro XV is screening of upper and lower distal extremity injuries.  The scope of this study is to evaluate the feasibility of the Accuro XV components to render a quality ultrasound image, to test its workflow in an Emergency Room (ER) setting, and to gather image data for algorithm development and testing.

Inclusion Exclusion

Age >18 years (including pregnant patients)

 An open fracture, grossly open wound, or severe angulation of the limb is present

Patient presenting for distal limb injury of the wrist, forearm, ankle, or lower leg

 Patients for whom the site investigator feels that study participation could prohibit or impair ongoing medical care.

Patient is scheduled to receive an X-ray (ordered or obtained as SOC) that includes a view of the ankle, lower leg, wrist, and/or forearm or any patient that received an X-ray accessible by the study team for the studied anatomy in the past 48 hours

 Known allergy to ultrasound couplants

  • PI: Edward Michelson, MD
  • Co-PIs: Nicholas Krejchi, MD & Edoardo Mena, MD

Study Purpose: Determine if the addition of a single dose of 8mg of dexamethasone after a head nerve block is associated with decreased recurrence of headache within 72 hours.

Inclusion Exclusion

Age >18 years (including pregnant patients)

 Head trauma

Meet ICHD-3 Migraine Headache Criteria

 Suspicion of secondary headache (i.e. stroke, known tumor, glaucoma)

Had a minimum 5-point reduction in headache intensity after nerve block(s) or with a post-block score of 0 to 2

 Headache in the setting of viral syndrome
Nerve block performed with bupivacaine 0.5% Chronically on steroids
  Known allergy to dexamethasone
  Unable to reach the patient by phone or text
  Gestational diabetes or other uncontrolled diabetes
  Known to be immunocompromised

  • PI: Edward Michelson, MD
  • Co-PIs: Nils Nickel, MD & Gregory Patek, MD

Study Purpose: To determine changes in an individual’s hemostatic phenotype based on Quantra QStat measurements immediately before and during thrombolysis with tPA.

Inclusion Exclusion

Age >18 years

 Pregnancy

Diagnosis of acute, moderate pulmonary embolism referred to the PE Response Team

 Does not meet one or more of the inclusion criteria

Candidate for an IV bolus and infusion of tPA based upon clinical status

  
Has no contraindications to thrombolysis  
Sufficiently stable to complete informed consent  

Completed Sponsored Clinical Trials

  • PI: Edward Michelson, MD
  • Co-PIs: Erik Nordquist, MD & Sarah Watkins, DO

Study Purpose: To evaluate if repurposed medications can make participants feel better faster and reduce death and hospitalization of COVID-19.

  • PI: Sarah Watkins, DO
  • Co-PI: Edward Michelson, MD

Study Purpose: Evaluate the efficay of IV varespladib in addition to SOC in subjects bitten by venomous snakes.

  • P.I. Edward Michelson, MD

Study Purpose: This study will evaluate the performance of TriVerity to diagnose bacterial and viral infections.

  • P.I. Edward Michelson, MD

Study Purpose: We are using a device known as BrainScope, a portable EEG device, to determine if the likelihood of a structural brain injury being present and potentially visible on CT scan. This is done to add confidence to the treating physician's decision.

  • PI: Leo Mercer, MD
  • Co-PI: Edward Michelson, MD

Study Purpose: Investigate the efficacy and safety of a single IV infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and or predicted to receive a large volume blood product transfusion.

Completed Investigator-Initiated Studies

  • PI: Edward Michelson, MD

Study Purpose:  Use ROTEM and SEER to characterize changes in stored whole blood over time, if any exist. We will record ROTEM parameters (EXTEM, INTEM, and FIBTEM) and similar SEER parameters (clot time (CT), fibrinolysis Index (FI), clot stiffness (CS), fibrinogen contribution (FCS)) at several timepoints over  21 days.

Inclusion Exclusion

Age >18 years <40 years

 Not meeting one or more of the inclusion criteria

Non-pregnant, not taking blood thinners, not taking oral contraceptives

  

In good health at time of consent and blood donation

  
No history of anemia  
No blood bank donation within last 30 days  
Within the last 7 days, have not taken an anti-platelet medication, aspirin or any other non-steroidal anti-inflammatory drug (NSAID)     

  • PI: Edward Michelson, MD

Study Purpose: Since the neurologic symptoms of some COVID patients resemble those of patients with concussion, the aim of this study is to identify EEG and cognitive function (brain fog) changes in long COVID patients.

  • PI: Edward Michelson, MD
  • Co-PI: Erik Nordquist, MD, Sarah Watkins, DO, Susan Watts, PhD & John Miller, PharmD

Study Purpose: We seek to use Cromolyn, traditionally described as a mast cell stabilizer, with standard COVID-19 treatment to improve symptoms and reduce the number of days to improved quality of life.

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