Clinical Trials

You are being asked to take part in this research study because you are scheduled to have total hip replacement (arthroplasty) surgery. The goal of this study is to evaluate the effectiveness of the drug, epsilon Aminocaproic Acid (EACA), in decreasing the need for patients to receive blood after surgery. Currently, EACA is approved by the Federal Drug Administration (FDA) to treat a patient who is bleeding. The investigators plan to use EACA to prevent bleeding during and after surgery; use of this drug as a means of preventing bleeding is not currently approved by the FDA.

The proposed study is a prospective multicentre investigation of the retinal findings in children less than 4 years old with acute elevations of intracranial pressure.

The purpose of this study is to assess outcomes of patients with Subarachnoid Hemorrhage (SAH) and establish their relationship to treatments in a prospective fashion.

The purpose of this study is to analyze intracranial bleeds and collections to better understand the mechanical properties and correlation with medical images. Understanding the fluid composition and mechanical behavior may allow the development of novel techniques and technology to drain hematomas and perform collections though minimally invasive approaches, thereby reducing patient discomfort and accelerating recovery.

The purpose of this study is to determine the effects of continuation vs. discontinuation of statins on the risk of Intracerebral Hemorrhage (ICH) recurrence during 24 months of follow-up in patients presenting with a spontaneous lobar Intracerebral Hemorrhage (lCH) while taking a statin drug. And we will also determine the effects of continuation vs. discontinuation of statins on the occurrence of any of the following major adverse cerebro- and cardio-vascular events (MACCE) (symptomatic ischemic stroke, symptomatic myocardial infarction, newly symptomatic arterial occlusive disease (peripheral, retinal, or carotid), revascularization procedures for coronary, carotid, or peripheral arterial disease, and vascular death). 

An ancillary MRI study will be ...

A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).

The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA ...

The purpose of this study is to determine the feasibility of using SSPGB to reduce the self-reported headache pain that patients with aneurysmal SAH experience during their hospital admission.

The purpose of this study is to determine if cytochrome P450 (CYP) enzyme family variants alter the body's metabolism of nimodipine after Aneurysmal Subarachnoid Hemorrhage (aSAH), and if actual levels of nimodipine correlate with clinical events and patient outcomes.

The purpose o fthis study

A total of 8,000 patients presenting to CPSs with acute-onset AIS, ICH or aSAH and no history of dementia will be enrolled within 6 weeks of stroke onset.

All participants will undergo baseline screening for evidence of pre-stroke dementia. Those who pass baseline screening will complete a blood draw and a series of cognitive and functional assessments at baseline.

Participants will undergo in-person (3-6 months, 18 months) and telephone (annual) follow-up visits for the duration of the study to assess for longitudinal cognitive and functional outcomes. In addition to Tier 1 procedures, at each in-person follow-up visit: Tier ...

The purpose of this study is to assess the differences in microvascular anastomosis outcomes between the experiment aneurysmal subarachnoid hemorrhage (aSAH)-like conditions and control animals.

The purpose of this study is to test for the long-term outcomes in function for stroke patients who get an early tracheostomy, versus those who have prolonged orotracheal intubation. 

Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. If they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. This so called tracheostomy might be associated with advantages such as less demand of narcotics and pain killers, less lesions in mouth and ...

The purpose of this study is to determine:  the incidence of hemorrhage in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia, and recurrent or progressive venous thromboembolism in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia.

The study aims to identify predictors of brain outcomes in Hereditary Hemorrhagic Telangiectasia (HHT) patients. The study will use the modified Rankin Score (mRS). Furthermore to define a severe bleeding phenotype in HHT for clinical trial readiness. 

The purpose of this study is to compare the effectiveness and safety of EG-1962 to the standard of care oral nimodipine for the treatment of adult patients who have an aneurysmal subarachnoid hemorrhage.

The purpose of this study is to to take the usual waste material from the removal of hematoma and apply an array of -Omics approaches (including for example genomics, transcriptomics, lipidomics, proteomics, and metabolomics) to identify biomarkers that assess prognosis and identify key therapeutic targets.

The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke.

The primary purpose of this study is to provide a subset of data using protocols of tolerance to lower-body negative pressure for validation of a commercially available wearable device that will be used in predicting hemorrhagic shock in persons suffering civilian and battlefield trauma.

A pivotal, prospective, multi-center, randomized, controlled, double-blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized task oriented rehabilitation will be conducted in patients with post-stroke motor impairment. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.

The purpose of this research study is to examine how certain genes and lifetime and ongoing stress may impact rehabilitation and recovery after stroke.

C3FIT’s overall goal is to assess if patient outcomes are improved when the Comprehensive and Primary Stroke Center (CSC/PSC) system is supplemented with an Integrated Stroke Practice Unit (ISPU) system of care, a patient-centric model of care involving the patient and caregiver/family that coordinates care from the acute management through the rehabilitation and recovery of the patient.

The purpose of this study is to establish a prospective, standardized data collection for the patients who undergo surgical treatment of progressive post-hemorrhagic hydrocephalus in neonates with the focus on comparing neuroendoscopic lavage (NEL) with other standard treatment options such as external ventricular drainage (EVD), ventricular access device (VAD) and ventricular subgaleal shunt (VSGS).

This research study seeks to explore the effects of massage techniques on pain and anxiety relief among patients with subarachnoid hemorrhages in the ICU setting in comparison to subarachnoid hemorrhagic patients using standard medical therapy.

The study is a non-blinded evaluation of the use of cervical spinal cord stimulation (SCS) for treatment of patients with Hunt and Hess grade 1-2 subarachnoid hemorrhage and evidence of cerebral vasospasm.

The purpose of this study is to provide clinical evidence of functional improvement, safety, and economic benefit when comparing intracerebral hemorrhage (ICH) evacuation surgery to medical treatment.

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The purpose of this study is to develop an increased understanding of the role of connective tissue structural abnormalities and impaired function (i.e. wound healing) in the development of intracranial aneurysms.

The purpose of this study is to see how much gabapentin will reduce headaches associated with subarachnoid hemorrhage (SAH) and to reduce the amount of narcotic pain medication prescribed.

The objective of this study is to evaluate the feasibility of detecting blood in the stomach of a patient with suspected Upper Gastrointestinal Bleeding (UGIB).

The purpose of this study is evaluate the reversal of the antiplatelet effects of ticagrelor with bentracimab (PB2452) in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure. Approximately 200 patients will be enrolled from approximately 200 centers in North America, Europe, and Asia-Pacific regions, including mainland China. Patients with reported use of ticagrelor within the prior 3 days who require urgent ticagrelor reversal will be eligible for enrollment. 

The purpose of this study is to develop prognostic and diagnostic blood tests for symptomatic brain hemorrhage in patients diagnosed with cavernous angiomas, a critical clinical challenge in a disease affecting more than a million Americans. We further examine whether blood biomarkers can replace or enhance the accuracy of advanced imaging in association with lesional bleeding. The project tests a novel integrational approach of biomarker development in a mechanistically defined cerebrovascular disease, with a clinically relevant context of use.

The purpose of this study is to evaluate if clazosentan (on top of normal routine medical care) can reduce the risk of developing complications related to cerebral vasospasm and permanent brain damage as compared to normal routine medical care alone.

The specific aims of this study are to:

1. Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset.
2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the subjects' quality of life as measured by EuroQol at 3 months.
3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of hematoma expansion (defined as increase from baseline hematoma volume of > ...

The primary purpose of this study is to determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF).

The purpose of this study is to examine the gait in patients with hemiplegia following a stroke, when wearing an ankle foot orthosis and without wearing an ankle foot orthosis.

The purpose of this study is to set up the infrastructure for future clinical trials for patients with cavernous malformations. To do this we will be assessing the quality of MRI and data collection from patients with cavernous malformations across multiple sites in the country. At Mayo, we will be looking at new MRI "sequences" in addition to the usual sequences to see if that helps determine which cavernous malformations may bleed again.

The purpose of this study is to identify important physiologic trends in bedside ICU data such as cerebral perfusion pressure (CPP), intracranial pressure (ICP) using a bedside “Multimodal monitoring” (MMM) computer which utilizes ICM+ Cambridge software.

Study summary:

The overall plan for this study is to conduct qualitative interviews among 40 family members of patients who have been hospitalized in a coma. Subjects for this study will be recruited by local site P.I.s from intensive care units at the following 18 U.S. centers:

All interviews will be conducted virtually via video conferencing by study staff at the Yale School of Medicine and Massachusetts General Hospital. All study activities following the interviews, including data analysis and manuscript writing, will take place at the Yale School of Medicine and Massachusetts General Hospital. We expect ...

The purpose of this study is to detect and characterizer electrophysiologic disturbances (such as local field potentials) in patients with underrecognized cause of coma, focal deficits and prolonged encephalopathy following subdural hematoma (SDH) evacuation.

The purpose is to study the effects of intraventricular nicardipine, a vasodilatory agent, on VP and secondary outcomes of stroke and functional outcome at 30 and 90 days compared to those not treated with this agent.

Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause acute and dramatic vision loss for patients with diabetes, there is no current, evidence-based clinical guidance as to what treatment method is most likely to provide the best visual outcomes once intervention is desired. Intravitreous anti-vascular endothelial growth factor (anti-VEGF) therapy alone or vitrectomy combined with intraoperative PRP each provide the opportunity to stabilize or regress retinal neovascularization. However, clinical trials are lacking to elucidate the relative time frame of visual recovery or final visual outcome in prompt vitrectomy compared with initial anti-VEGF treatment. The Diabetic Retinopathy Clinical Research ...

The aim of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in Florida. The Center will collect and store detailed phenotypic information, DNA, and other biofluids on affected subjects with diverse cerebrovascular conditions, including, but not limited to, ischemic stroke, transient ischemic attack (TIA), intracerebral hemorrhage (ICH), aneurysmal subarachnoid hemorrhage (aSAH), vascular dementia (VAD), anoxic brain injury, unruptured intracranial aneurysm (UIA), cavernous malformation, arteriovenous malformations (AVM), carotid and vertebral arterial dissections, symptomatic and asymptomatic cervical carotid artery atherosclerotic stenosis, non-aneurysmal perimesencephalic subarachnoid hemorrhage (naSAH), cerebral venous thrombosis (CVT), moyamoya disease, fibrosmuscular dysplasia (FMD), non-traumatic, angiography-negative subarachnoid ...