PI: Osbun

Protocol ID: D00121056

Short study title: MMA Embolization for Chronic and Subacute SDH (EMBOLIZE)

Short description: Multi-center, randomized, open label. MMA embolization can inhibit blood flow to pathologic structures receiving blood through meningeal arteries and can control bleeding from the cSDH membrane and enhance resolution of the SDH and prevent recurrence. This study utilizes Onyx, a liquid embolic, which has advantages over polyvinyl alcohol (PVA) particles in that it is inexpensive, can provide distal penetration, is permanently opacified, and can be injected under direct pressure. Primary endpoint is rate of recurrence/progression requiring surgical drainage within 90 days post treatment. Neurosurgeon determines whether a patient needs surgery (surgery group or observational group) then the patient is randomized to a control arm (surgery or observation only) and experimental arm (+/- MMA embo).

Key eligibility criteria:

  • Any sex, age 18 through 90
  • cSDH or saSDH with > 1mm midline shift or flattening of brain
  • Acute blood < 50%
  • Randomization to be completed within 24 hours of screening
  • All interventions to be completed within 48 hours of randomization
  • Excludes: life expectancy < 1 year, prior treatment of SDH, patients who cannot be off anticoagulation for at least 4 weeks post randomization, INR > 1.4 that cannot be corrected, COVID-19 positive, GFR < 30, patients who cannot be off steroids for at least 90 days post randomization, pregnancy

Contact person: Brigette Vaughn, 314-273-0368, b.vaughn@wustl.edu

Enrollment period: October 27, 2020 – January 2023

For more information: https://clinicaltrials.gov/ct2/show/NCT04402632

PI: Osbun

Short study title: Dural Arteriovenous Fistula Genetics Repository

Short description: The aim of this study is to generate a biospecimen repository for the analysis for the genomic determinants of dural arteriovenous fistula pathophysiology. Consented patients will supply a saliva or blood sample which will be linked with clinical outcomes data. The long-term goal of this study is to provide information to help in future candidate gene studies, genome-wide association studies, and/or rare variant analyses. The information garnered may one day serve as biomarkers for patient risk-stratification into more or less aggressive medical therapy and monitoring groups and elucidate pathways to study and develop targeted therapeutic strategies.

Key eligibility criteria:

  • Diagnosis of dural arteriovenous fistula
  • Any sex, age 18 and up
  • Willingness to provide blood sample (20-30cc) or saliva sample

Contact person: Brigette Vaughn, 314-273-0368, b.vaughn@wustl.edu

Enrollment period: January 30, 2020 – Current

PI: Osbun

Short study title: aSAH Genomics and Biospecimen Repository

Short description: DNA isolated from peripheral blood can be used to evaluate potential genomic polymorphisms associated with disease predisposition or treatment response. This study aims to collect, process, and bank biospecimens (blood and/or saliva) from aSAH patients.

Key eligibility criteria:

  • Any sex, age 18 and up
  • Confirmed aSAH by CT, DSA, or LP
  • Aneurysm secured by coil or clip
  • Excludes: No expectation of meaningful recovery/DNR/GCS < 4

Contact person: Brigette Vaughn, 314-273-0368, b.vaughn@wustl.edu

Enrollment period: October 2019 – Current

PI: Zipfel

Protocol ID: ID-054-304, REACT

Short study title: pRevention and trEament of vAsospasm with CloazosenTan (REACT)

Short description: Multi-center, randomized, double-blinded, placebo-controlled, Phase 3 study in adult patients with aSAH. Clazosentan is a highly specific endothelin receptor antagonist that has vasodilatory properties in the brain and moderate systemic vasodilatory effects. In both nonclinical and clinical settings, clazosentan prevents the occurrence of vasospasm post-aSAH. In a recent exploratory clinical study (REVERSE), clazosentan showed some pharmacological effect on large vasospastic brain vessels as early as 3 hours post-study drug initiation with minimal effect on the systemic circulation, suggesting that clazosentan may be beneficial in early treatment of vasospasm post-aSAH. A total of 1800 clazosentan-treated subjects in 7 double-blind placebo-controlled clinical trials (3 Phase 2, 4 Phase 3, 1 Phase 2 open label study) have shown decreased incidence and severity of cerebral vasospasm. Treatment will be started no later than 96 hours post-aSAH and continue, when possible, for 10-14 days where they will remain in the ICU.

Key eligibility criteria:

  • Any sex, age 18 through 70
  • Treatment no later than 96 hours post-aSAH
  • Includes: ruptured aneurysm with SAH secured within 72h of rupture, GCS 7 or higher (WFNS grade 1-4) after securing procedure and EVD (if required)
  • Excludes: unresolved pulmonary edema, significant pneumonia, or hypoxia (PaO2/FiO2 < 200), additional unruptured aneurysm with intervention planned within 3 months of SAH, significant bleeding post securing procedure, IVH > 50% of both LVs/3rd/4th, IPH volume > 50cc, vasospasm at admission, pregnancy

Contact person: Brigette Vaughn, 314-273-0368, b.vaughn@wustl.edu

Enrollment period: December 15, 2018 – December 2021

For more information: https://clinicaltrials.gov/ct2/show/NCT03585270

PI: Leuthardt

Protocol ID: 202007034

Short study title: Transauricular Vagus Nerve Stimulation Following Spontaneous SAH

Short description: Single center, double-blinded, randomized trial. Vagus nerve stimulation (VNS) has previously been established to have anti-inflammatory effects. VNS in a mouse model of cerebral aneurysms and SAH reduced the rupture rate of intracranial aneurysms, reduced the grade of hemorrhage if rupture occurred, and improved survival and outcome after SAH. The aim of this study is to prospectively study transauricular VNS in our spontaneous SAH population. Inflammatory markers in the blood and CSF (if an EVD is in place) will be collected. Information regarding development of vasospasm, need for permanent CSF diversion, and mRS will be collected.  

Key eligibility criteria:

  • Any sex, age 18 and up
  • Spontaneous SAH
  • Notify contact person as soon as diagnosis is determined
  • Participants or appropriate representative will have no more than 24 hours to consent
  • Excludes: primarily traumatic SAH, active cancer treatment, sustained bradycardia (HR < 50) on arrival

Contact person: Anna Huguenard, 314-450-6698, ahuguenard@wustl.edu

Enrollment period: December 2020 – October 2022

For more information: https://clinicaltrials.gov/ct2/show/NCT04557618

PI: Chicoine

Protocol ID: NCT02880878

Short study title: Early Minimally-Invasive Removal of ICH (ENRICH)

Short description: Multi-center, randomized, trial comparing medical management to early (<24 hours) surgical hematoma evacuation using minimally invasive parafascicular surgery (MIPS) for acute spontaneous supratentorial ICH. Previous trials (STICH, STICH II, MISTIE II, and MISTIE III) have had their limitations and a clear benefit for hematoma evacuation and for which patient population have not yet been proven. This study utilizes MIPS, which combines the potential benefits of surgical hematoma evacuation while minimizing iatrogenic trauma to adjacent brain tissue. The purpose this study is to provide substantial clinical evidence of functional improvement, safety, and economic benefit when comparing ICH evacuation surgery to medical treatment.

Key eligibility criteria:

  • Any sex, age 18 through 80
  • ICH volume 30-80cc as calculated by ABC/2 method
  • GCS 5-14
  • Intervention can be initiated within 24 hours of onset of symptoms (or LKN)
  • Excludes: ruptured aneurysm, AVM, Moyamoya, VST, mass or tumor, hemorrhagic conversion of ischemic infarct, recurrence of ICH (<1 year prior), intraventricular extension > 50% of either LV, primary thalamic ICH, infratentorial, platelets < 75,000 or INR > 1.4 after correction, no reasonable expectation of recovery prior to randomization

Contact person: Brigette Vaughn, 314-273-0368, b.vaughn@wustl.edu

Enrollment period: December 2016 – November 2022

For more information: https://clinicaltrials.gov/ct2/show/NCT02880878

PI: Ray and Osbun

Short study title: Wearable and Wireless Pressure Sensor for Monitoring Skin Pressure (Mercury Patch)

Short description: Hospital-acquired pressure ulcers are preventable problems that carry significant morbidity despite close monitoring. These complications are more prevalent among patients with neurologic injury or paralysis. Our group and other have developed the Mercury Patch, a noninvasive, low-cost, wireless, flexible patch that contains pressure-sensing and transmitting features that could communicate information about continuous skin pressure. The goal of this study is to use the Mercury Patch to record sacral pressure during prolonged neurosurgical procedures and relate them to patient characteristics and outcomes such as pressure ulcer development and bladder/bowel incontinence.

Key eligibility criteria:

  • Age 18 and up
  • Patients scheduled to undergo any cranial or skull base surgery lasting longer than four hours in duration and is able to follow up for 2-4 weeks after surgery
  • Excludes: patients with existing or prior sacral pressure ulcer, pre-existing impaired skin integrity, history of pilonidal cyst, cellulitis, psoriasis, or eczema, patients who are bedridden or have impaired mobility, BMI > 40, lower back tattoos, allergy to silicone adhesives or Tegaderm

Contact person: Linda Koester, 314-362-7368, koesterl@wustl.edu

Enrollment period: November 2021 – Current