David Dornbos, III, MD

ANNEXa-I: A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients receiving an Oral Factor Xa Inhibitor

Status: Upcoming

Sponsor: Portola Pharmaceuticals, Inc.

Principal Investigator at UK: David Dornbos III, MD

Purpose: This is a randomized, multicenter clinical trial designed to determine the efficacy and safety of andexanet compared to usual care in patients presenting with acute intracerebral hemorrhage within 6 hours of symptom onset (from the baseline scan) and within 15 hours of taking an oral FXa inhibitor (from randomization). The primary efficacy outcome will be adjudicated by a blinded Endpoint Adjudication Committee (EAC). To support the adjudication of hemostatic efficacy, a blinded Imaging Core Laboratory will review all available scans. Approximately 900 patients are planned to be enrolled in the study. Primary Efficacy Objective: To evaluate the effect of andexanet versus usual care on the rate of effective hemostasis. Secondary Efficacy Objective: To evaluate the effect of andexanet versus usual care on anti-fXa activity and to evaluate the effect of andexanet versus usual care on neurologic function.

Condition: Intracranial hemorrhage

Study type: Randomized clinical trial, Phase IV

Other info: https://clinicaltrials.gov/ct2/show/NCT03661528

EXPECTANT: Evaluation of X-ray Penetration Concerning Teratogenicity And NeuroinTervention

Status: Upcoming

Sponsor: Semmes-Murphey Clinic

Principal Investigator at UK: David Dornbos III, MD

Purpose: This study is a multicenter trial assessing potential radiation dose to a fetus in pregnant neurointerventionalists. The radiation dose to a fetus will be estimated based on dosimetry readings during routine endovascular procedures. Case information for a span of 90 days, including location, procedure type, radiation and fluoroscopy dose details will be assessed and their potential impact on interventionalists while pregnant.

Condition: Neurointervention

Acute Alterations in CT Perfusion Imaging following Thrombectomy for Acute Ischemic Stroke

Status: This is a clinical study that is currently enrolling subjects

Principal Investigator-Initiated Study / Principal Investigator: David Dornbos III, MD

Sponsor: Siemens Healthineers

Purpose: This is a prospective trial assessing CT perfusion imaging immediately pre- and post-thrombectomy utilizing a new state of the art software platform to obtain perfusion imaging on the angiography table, to validate its efficacy, and to compare the acute alterations in penumbra and ischemic core induced by reperfusion.

Condition: Acute ischemic stroke

Intervention: CT perfusion before and immediately after thrombectomy

Contact: Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator

Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial

Status: This is a clinical study that is currently enrolling subjects

Sponsor: University of Minnesota/Hennepin County Medical Center

Funding: NIH National Institutes of Neurological Disorders and Stroke

Principal Investigator at UK: David Dornbos III, MD

Purpose: There continues to be high mortality and poor outcome for victims of severe traumatic brain injury (TBI). Preclinical and clinical investigations indicate that hyperbaric oxygen (HBO) has a positive impact on reducing brain injury and improving outcomes in severe TBI. By markedly increasing oxygen (O2) delivery to the traumatized brain, HBO can reverse the lack of O2 that precipitates cellular energy failure and subsequent brain cell death. However, prior to a formal phase III definitive efficacy study, important information is required regarding optimizing the HBO treatment schedule to be instituted in terms of pressure, frequency and other parameters. The lungs in severe TBI subjects have frequently been compromised by direct lung injury and/or acquired ventilator pneumonia and are susceptible to O2 toxicity. It is essential to determine the most effective HBO dose schedule without producing O2 toxicity and clinical complications. This proposed adaptive clinical trial is designed to answer these questions and to provide important data to plan a definitive phase III efficacy trial.

Condition: Traumatic brain injury

Study type: Randomized clinical trial, Phase II

Other info: https://clinicaltrials.gov/ct2/show/NCT02407028

MASTER (Moyamoya and Stroke Tissue Evaluation and Repository)

Status: Recruiting

Principal Investigator at UK: Jill Roberts, PhD Department of Neurosurgery, University of Kentucky

Sub Investigator at UK: Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky    Jessica Lee, MD, Department of Neurology, University of Kentucky    David Dornbos, III, MD, Department of Neurosurgery

Sponsor: NIH National Center for Advancing Translational Sciences and UK Center for Clinical and Translational Science

Purpose: This is an un-blinded clinical and biological registry to evaluate specific questions to aid in the understanding of moyamoya syndrome.  Blood samples and clinical data are evaluated for specific inflammatory proteins and their correltion to moyamoya severity and presence of comorbidities.

Condition: Moyamoya

Intervention: There is no therapeutic intervention involved in this study.

Contact: Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator 

Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

EMBOLISE (Embolization of the Middle Meningeal Artery with ONYXTM Liquid Embolic System in the Treatment of Subacute and Chronic Subdural Hematoma)

Status: Recruiting

Principal Investigator at UK: Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Sub Investigator at UK: David Dornbos, III, MD, Department of Neurosurgery, University of Kentucky

Sponsor: Medtronic Neurovascular

Design: A multi-center, prospective, randomized, interventional, controlled, open label, adaptive design

Purpose: To evaluate the safety and effectiveness of Onyx™ LES embolization of the MMA as an adjunct to conventional treatment (surgery or observation) for symptomatic subacute or chronic subdural hematoma.

Condition: Subdural Hematoma

Study Cohorts: Surgery Cohort and Observation Cohort, with control and experimental arms within each cohort.

Other information: ClinicalTrials.gov Identifier: NCT04402632

https://clinicaltrials.gov/ct2/show/NCT04402632?term=embolise&draw=2&rank=1

Contact: Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator 

Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

ELEVATE (EvaLuate EndoVascular treatment of Acutely reputured shallow intradural aneurysms with the Pipeline™ Flex Embolization Device with Shield TEchnology™)

Status: Upcoming/not yet recruiting

Principal Investigator at UK: Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Sub Investigator at UK: David Dornbos, III, MD, Department of Neurosurgery, University of Kentucky

Sponsor: Medtronic Neurovascular

Design: Multicenter, prospective, single-arm, adaptive IDE study

Purpose: To assess the safety and effectiveness of constructive treatment with the Pipeline, Shield Device in adults with acutely ruptured intradural aneurysms that are shallow (dome to neck ratio 1) and are deemed unfavorable for both, clipping and coiling.

Condition: Ruptured intradural aneurysms

Other information: ClinicalTrials.gov Identifier: NCT04391803

https://clinicaltrials.gov/ct2/show/NCT04391803?term=elevate&cond=aneurysm&draw=2&rank=1

Contact: Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator 

Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

CITADEL (The Citadel Embolization Study)

Status: Upcoming/not yet recruiting

Principal Investigator-Initiated Study / Principal Investigator: Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Sub Investigator at UK: David Dornbos, III, MD, Department of Neurosurgery, University of Kentucky

Internal Financial Sponsor: Stryker Neurovascular 

Purpose: The purpose of this study is to gather preliminary safety and effectiveness data on Stryker Neurovascular’s Next Generation Target Detachable Coil (Citadel Embolization Device), when used with Target Detachable Coils, in the treatment of wide-neck intracranial aneurysms. 

Condition: Intracranial aneurysms

Study Design: Prospective, multicenter, single-arm, non-randomized clinical study

Other information: ClinicalTrials.gov Identifier: NCT04057352

https://clinicaltrials.gov/ct2/show/NCT04057352?term=citadel&cond=aneurysm&draw=2&rank=1

Contact: Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator

Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

MIND (A Prospective, Multicenter Study of Artemi a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage)

Status: Recruiting

Principal Investigator at UK: Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Sub Investigator at UK: David Dornbos, III, MD, Department of Neurosurgery, University of Kentucky

Sponsor: Penumbra, Inc.

Design:

• Allocation: Randomized

• Intervention Model: Parallel Assignment

• Intervention Model Description: Subjects will be randomized to either minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management (MIS group) or best medical management alone (2:1) (MM).

• Masking: Single (Outcomes Assessor)

• Masking Description: 180 day mRS is blinded

• Primary Purpose: Treatment

Purpose: The primary objective of this multicenter randomized controlled study is to compare the safety and efficacy of minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device to best medical management for the treatment of intracerebral hemorrhage (ICH).

Condition: Intracerebral hemorrhage (ICH), Cerebral Hemorrhage, Brain Hemorrhage, Cerebral Parenchymal Hemorrhage.

Participants: The target population are patients ≥ 18 and ≤ 80 years of age who have a diagnosis of spontaneous, non-traumatic, intracerebral hemorrhage (ICH) ranging ≥ 20 and < 80 cc, with an associated significant neurological deficit (NIHSS ≥ 6) who do not require emergent open surgical decompression related to uncontrolled intracranial pressure or mass effect.

Intervention:

• Device: Artemis + Medical Management

Subject will receive best MM in addition to the MIS procedure with Artemis.

• Other: Best Medical Management Alone (MM)

Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.

Study Arms:

• Experimental: Artemis + Medical Management (MIS):

  • Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
    
    Intervention: Device: Artemis + Medical Management

• Active Comparator: Best Medical Management Alone (MM)

  • Best medical management alone per standard of care at treating institution
    
    Intervention: Other: Best Medical Management Alone (MM)

Other information: ClinicalTrials.gov ID # NCT03342664

https://clinicaltrials.gov/ct2/show/record/NCT03342664?term=MIND+Intracerebral+Hemorrhage&draw=2&rank=1

Contact: 

• Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator 
  
  Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

Team Members:

• David Dornbos, III, MD
• Jennifer Isaacs
• Jacque Frank
• Stephanie Morris
• Travis Sexton
• Lindsey Parker
• Hilary McCord
• Rachel Norris