Clinical Trials

Neurotrauma Clinical Trials

The Neurotrauma Clinical Trials Center, under the direction of David O. Okonkwo, MD, PhD, is comprised of a team of clinicians who assume responsibilities over the screening and enrollment of patients with mild, moderate, and severe traumatic brain injury (TBI). Clinical brain injury research is wide spanning and includes clinical trials funded by federal agencies and industry to study new therapies, novel brain monitoring, advanced neuroimaging, and biomarkers.

The center also houses the National TBI Biospecimens Repository. This repository, under the direction of Ava Puccio, RN, PhD, supports the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study, a multi-center initiative funded by the National Institutes of Health (NIH), and is the largest centralized collection of biological samples from TBI patients in the United States.

The Department of Neurological Surgery has pioneered efforts using hypothermia and cerebral blood flow monitoring in the treatment of severe head injury and has conducted landmark investigations into the mechanisms of induction and recovery of head trauma and secondary injury. Current clinical neurotrauma studies include:

Current Trials

A Double-Blind, Controlled Phase 2 Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Traumatic Brain Injury (TBI)

Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury (TEAM TBI)

In Vivo Neuroimaging Biomarker Panel for Traumatic Brain Injury (CTE Neuroimaging)

TBI Biological Diagnosis via High Definition Tractography Asymmetry Screening (HDFT)

Transforming Traumatic Brain Injury Research and Clinical Care: TRACK-TBI

The HOPES Trial: HypOthermia for Patients requiring Evacuation of Subdural Hematoma: A Multicenter, Randomized Clinical Trial

Spreading Depressions as Secondary Insults after Traumatic Brain Injury to the Human Brain

Biochemical Analysis of Cerebrospinal Fluid and Brain Tissue Following Moderate/Severe Head Injury (BTRC)

Cerebrovascular Clinical Studies

As one of the country’s leading referral centers for cerebrovascular disease, UPMC participates in a wide range of clinical trials. Many of these studies are coordinated through the UPMC Stroke Institute in the Department of Neurology, which actively participates in trials of both ischemic and hemorrhagic stroke. This is a multi-disciplinary effort involving investigators and teams from the departments of neurology, neurological surgery, critical care medicine, and emergency medicine. Current clinical trials run through the UPMC Stroke Institute include (more detailed info on these trials will be included here soon):

Ischemic Stroke Studies

Carotid Revascularization for Primary Prevention of Stroke (CREST 2) Trial

Platelet-Oriented inhibition in New TIA and minor ischemic stroke (POINT) Trial

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

A Study of the Efficacy and Safety of Activase (Alteplase) in Patients with Mild Stroke (PRISMS)

Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) Trial

Safety Evaluation of 3K3A-APC in Ischemic Stroke (NN104 RHAPSODY)

SolitaireTM FR as Primary Treatment for Acute Ischemic Stroke (SWIFT PRIME)

GORE HELEX Septal Occluder / GORE Septal Occluder for Patent Foramen Ovale (PFO) Closure in Stroke Patients- The Gore REDUCE Clinical Study

A Study of Modified Stem Cells in Stable Ischemic Stroke

Study to Examine the Effects of MultiStem in Ischemic Stroke

Computed Tomography Perfusion (CTP) to Predict Response to Recanalization in Ischemic Stroke Project (CRISP)

Trevo and Medical Management versus Medical Management Alone in Wakeup and Late Presenting Strokes (DAWN)

Patient-centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) Trial

Glyburide Advantage in Malignant Edema and Stroke (GAMES) Trial

Hemorrhagic Stroke/Aneurysm Studies

Intra-arterial Vasospasm Trial (IVT)

Ultra 3 Registry

Low Profile Visualized Intraluminal Support Device (LVIS) Study

BARREL Vascular Reconstruction Device Study

Clot Lysis: CLEAR III Trial

STOP-IT (Using Spot-sign to predict hematoma growth)

Anti-hypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II) Trial

Minimally Invasive Surgery Plus rt-PA for Intracerebral Hemorrhage Evacuation (MISTIE-III) Trial