Clinical Research Directory

One-Stop manaGemEnT For A Swift Initiation of Endovascular Therapy

Stroke, especially acute ischemic stroke (AIS) caused by a blocked blood vessel in the brain, is a leading cause of death and long-term disability. When the blockage is in a large blood vessel, a procedure called endovascular therapy (EVT)-where the clot is removed using a catheter-is highly effective. However, the sooner EVT is done, the better the outcome for the patient. Research has shown that delays between arriving at the hospital and starting EVT (called door-to-groin time) significantly reduce the chances of recovery. For example, reducing this time by just 15 minutes can mean 20 more patients (out of 1,000 treated) going home instead of to a care facility. Even a 10-minute improvement can result in over 100 extra days of independent living for patients and save more than $10,000 in healthcare costs per patient. To reduce these delays, hospitals have improved stroke workflows. In the current standard approach, patients suspected of having a stroke are taken first to a CT scan room to confirm the diagnosis, and then, if a treatable occlusion is found, to a separate room for EVT. This usually takes around 60-70 minutes. However, moving patients between rooms takes time. A new approach called "One-Stop management" could solve this. In this method, both the brain scan and the EVT procedure are done in one room-the angiography suite-using special imaging tools called flat panel CT (FDCT) and FDCT angiography (FDCT-A). A previous study with 230 patients showed that One-Stop management is possible and saves time. But there's a challenge: the decision to follow the One-Stop pathway is made before a clear diagnosis is available. That's important because not all strokes benefit from EVT. Severe stroke symptoms (measured by a score called NIHSS ≥10) can come from: * A large or medium vessel blockage (which EVT can treat), * A small vessel blockage, or * A bleed in the brain (hemorrhage). Only the first group benefits from EVT. About 85% of patients with severe symptoms fall into this category. The rest-about 15%-would not benefit, and there are concerns that FDCT might be slightly less accurate than regular CT in diagnosing these types of strokes. So, we need to test whether One-Stop management is safe and effective for all patients, not just those with treatable blockages. To do this, the GET-FAST trial will compare the One-Stop approach to the standard two-room process. Patients will be randomly assigned to one of the two strategies. Importantly, this randomization won't affect their actual treatment-everyone will still receive the best care according to current medical guidelines. The main endpoint for the evaluation of the One-Stop approach will be long-term (at 90 days) disability and dependency in daily life as measured with the modified Rankin Scale (mRS). This study will include all patients as they were assigned, regardless of what type of stroke they actually had. This is called an "intention-to-treat" analysis, and it provides the most reliable measure of the overall impact of One-Stop management. Another key aspect of the trial is that any CE-certified imaging system already used in hospitals can be used for the One-Stop process-no specific brand or model is required. This makes the results more applicable to real-world hospital settings. If GET-FAST proves that One-Stop management leads to better patient outcomes, this could transform how stroke care is delivered. More patients could return to independent living, and fewer would require long-term care -leading to major reductions in healthcare costs. For example, even a one-point improvement on a common stroke disability scale (mRS) can triple the savings in lifetime care costs.

Feasibility of a Digital Goals-of-Care Decision Aid for Clinicians and Families of Patients With SABI

The goal is to pilot test a highly accessible, web-based, pragmatic, scalable intervention to overcome ongoing problems with high stakes decision-making by surrogate decision-makers of patients in ICUs with severe acute brain injury (SABI), including those with moderate-severe traumatic brain injury, large hemispheric acute ischemic stroke and intracerebral hemorrhage.

Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures

This research is studying a device already approved by the Food and Drug Administration (FDA) to treat wound closures. Researchers are studying a large group of people to continue to learn information about the safety of the STRATAFIX suture and how people's bodies react to using it over a long period of time. This research will provide additional information about using STRATAFIX sutures to close surgical wounds.

Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage - a Prospective Randomized Open Blinded End-point Trial

This study is designed to determine the safety and feasibility of using Cerebrolysin in treating primary intracerebral hemorrhage (ICH). This is a multicenter, prospective, randomized, open-label, blinded end-point, phase IV parallel group study done in specialized stroke treatment centers in Poland. The study objective is to evaluate if a 14-day cerebrolysin treatment initiated within 6 hours of onset of primary lobar hemorrhage in addition to the standard of care that includes early intensive rehabilitation is safe and feasible, affects hematoma growth and improves the outcome. This study is designed to assess the early effect of using Cerebrolysin in patients after ICH, therefore 3 months of follow-up has been chosen. Patients will receive 50 ml of Cerebrolysin once daily until day 14. Subjects will be evaluated on Day 1 (baseline), Day 2, Day 7, Day 30 and Day 90. Enrollment to the study is expected to reach 30 subjects in 12 months. The study should be completed within 15 months (the end of study). The primary outcome measure will be change from baseline in functional independence (mRS 0-2) at Day 90 following stroke onset. The safety outcome will be the number of serious adverse events until Day 30.