Active clinical trials for "Subarachnoid Hemorrhage"

This is a single-site, single-arm, open-label pilot study assessing the safety, feasibility, and efficacy of non-invasive vagus nerve stimulation (nVNS), gammaCore, for the acute treatment of aneurysmal subarachnoid hemorrhage (SAH) subjects in a neurocritical care setting. 25 patients will be enrolled, all treated with an active device. The primary efficacy outcomes are reduced aneurysm rupture rate, reduced seizure and seizure-spectrum activity, minimized hemorrhage grades, and increased survival.

Hyponatremia is defined as a plasma sodium concentration below 135 mmol / L. This is a common occurrence (20-50%) during subarachnoid hemorrhage (SAH). Its appearance is often associated with vasospasm. It is associated with an increase in morbidity and mortality linked to induced neurological disorders. Hyponatremia is caused by two etiologies: the syndrome of inappropriate secretion of anti-diuretic hormone (SIADH), and the cerebral salt wasting syndrome, CSWS. Theoretically, these two entities are differentiated by the patient's volemia; in practice, this parameter is difficult to measure. In addition, the correction of hyponatremia is diametrically opposed according to its mechanism: water restriction in the case of SIADH, sodium intake in the event of CSWS. Urea is offered as a second-line treatment in the event of treatment failure to correct hyponatremia. However, the efficacy of this treatment is based on small, observational, retrospective studies. Moreover, the mechanism of action of urea remains poorly understood: it could be a hyperosmolar effect or passive renal reabsorption of sodium.

Subarachnoid hemorrhage (SAH) is a frequent and severe disease. Mortality can reach 40%. The most frequent complication of SAH is arterial vasospasm, with estimated incidence as high as 70%. Vasospasm is responsible for cerebral ischemia leading to severe morbidity, poorer quality of life and increased mortality. Intravenous Milrinone, because of vasodilatory properties could be a therapeutic option. We hypothesize that intravenous infusion of Milrinone will improve the neurological recovery of patients with vasospasm following aneurysmal SAH at 3 months. This is a Phase III, multi-center, randomized, double-blinded, placebo-controlled study. The primary outcome will be the proportion of patients with a good outcome 3 months (defined as a modified rankin score ≤2).

The present study is a randomized, multi-center, double-blind, prospective study that tests the efficacy of intravenous milrinone to optimize cerebral hemodynamic and prevent delayed cerebral ischemia (DCI) during the high-risk period (day 4- day 14) in patients with severe subarachnoid hemorrhage due to intracranial aneurysm rupture (SAHa) (WFNS IV-V). The main objective is to evaluate, in comatose patients and / or sedated on D3 following a severe SAHa (WFNS IV -V), the effect of 10 days of milrinone versus placebo, in addition to the usual management, on the volume of DCI lesions measured on CT scan at 1 month.

The DRAIN trial is an international multi-centre, 1:1 randomised, parallel-group, superiority clinical trial investigating gradual weaning vs. prompt closure of external ventricular drainage in patients with hydrocephalus following aSAH. The primary objective is to investigate the beneficial and harmful effects of gradual weaning versus prompt closure of EVD treatment in patients with aSAH.

Intracerebral hemorrhage (ICH) is one of the common fatal types of cerebral apoplexy with high mortality and disability rates. Hematoma volume and complications of intracerebral hemorrhage are major predictors of early death and poor prognosis. The hematoma and its metabolites are key therapeutic targets. At present, in order to improve the prognosis of patients, cerebrospinal fluid(CSF) replacement with normal saline(NS) is commonly used in clinical practice to clear the bloody components, which shows a good clinical effect. However, due to the large difference between NS and CSF composition, it is easy to cause secondary injury of brain tissue. Therefore, the replacement of artificial CSF with similar CSF composition will be more effective in reducing the incidence of complications and improve the prognosis of neurological function. The Magnesium-rich Artificial Cerebrospinal Fluid(MACSF) was designed and developed in the early stage of this project which has similar physical and chemical properties to physiological CSF, such as ion species, concentration, the potential of hydrogen (pH) value, and osmotic pressure. Animal experiments had confirmed its safety and effectiveness. In this study, patients with basal ganglia intracerebral hemorrhage ruptured into the ventricle or subarachnoid hemorrhage were stratified randomly divided into MACSF group and NS group. MACSF and NS were used as replacement fluid for lumbar puncture CSF replacement, respectively. By observing and comparing two groups of patients of the Modified Rankin Scale (mRS) on the days14, 30, 60 and 90 after onset; hematoma absorption rate, hemorrhagic CSF removal rate; changes of cerebral autoregulation； incidence of complications, such as acute obstructive hydrocephalus (AOH) and cerebral vasospasm (CVS); the changes of scores and scales about imaging; assessment of neurological function recovery, such as the National Institutes of Health Stroke Scale (NIHSS) and the Glasgow Coma Score (GCS) during hospitalization, headache duration and the Visual Analogue Scale (VAS), vomiting duration, duration of meningeal irritant, ICU hospitalization duration, total hospitalization duration; change of CSF and peripheral blood biochemical indicators. The objective is to evaluate MACSF replacement therapy in patients with basal ganglia cerebral hemorrhage broken into ventricles and nonaneurysmal subarachnoid hemorrhage of the influence of absorption rate and prognosis.

Cortical spreading depolarisations are pathological depolarisation waves that occur frequently after severe acute brain injury and has been associated with poor outcome. S-ketamine has been shown to inhibit cortical spreading depolarisations. The aim of the present study is to examine the efficacy and safety of using S-ketamine for treatment of patients with severe acute brain injury, as well as the feasibility of the trial design.

Aneurysmal subarachnoid hemorrhage (aSAH) has a high incidence of mortality and significant morbidity, with mortality exceeding 30% in the first two days.The initial injury is related to increasing intracranial pressure, cerebral edema, and neuronal injuries associated with the release of iron. Iron has been shown to increase the incidence of cerebral edema, ischemia, and formation of hydrocephalus. Deferoxamine mesylate (DFO), a hydrophilic chelator, creates a stable complex with free iron thus preventing the formation of iron related free radicals. This trial will evaluate the safety and efficacy of clinical deferoxamine for the treatment of aSAH for patients that are admitted to the hospital at the University of Michigan or Peking University Health Science Center. Eligible participants will be enrolled and randomized to 1 of 2 doses of Deferoxamine or placebo (saline). Information regarding the patients will be collected and followed for up to 6 months post discharge.

This is a monocentric randomized prospective trial comparing 2 different endovascular strategies of intracranial arterial angioplasty in case of refractory intracranial arterial vasospastic stenosis : chemical angioplasty chemical and mechanical angioplasty

In recent years, many developments have been made to the tools and techniques used to treat IAs via endovascular intervention. Specifically, to the detachable coils themselves. In March 2018, the US Food and Drug administration granted Balt USA 510(k) clearance for the Optima Coil System™. Earlier this year, the list of devices included within the system has expanded to include OptiMAX Complex Super Soft and Complex Soft coils. It consists of coils that come in Standard, Soft and Super Soft profiles and allows for instant detachment from the pusher. The APPLY study is a prospective, single-center investigator-initiated study meant to assess the use of the Balt Optima™ Coil System. The site is looking to enroll approximately 30 subjects over the course of two years. The Optima Coil System™ is commercially available in the United States as such this study is looking for real-world data.