View clinical trials related to Brain Edema.
Filter by:Literature reports the development of brain oedema following the use of certain drugs. Therefore, this study aims to present a comprehensive disproportionality analysis of brain oedema cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS).
The DEXCON-TBI trial is a multicenter, pragmatic, randomized, triple-blind, placebo controlled trial to quantify the effects of the administration of dexamethasone on the prognosis of TBI patients with brain contusions and pericontusional edema. Adult patients who fulfil the elegibility criteria will be randomized to receive dexamethasone or placebo. Patients who have suffered a head injury and have one or more cerebral contusions with visible pericontusional edema in the CT scan can be included in the study. The doses of dexamethasone will be a short and descending course: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days). The primary outcome is the Glasgow Scale Outcome Extended (GOSE) performed one month and 6 months after trauma. Other secondary outcomes are: compare the number of episodes of neurological deterioration; compare the symptoms associated with TBI; compare the presence of adverse events during treatment; compare the volume of pericontusional edema before and after 12 days of treatment in both groups of patients; and compare the results of the neuropsychological tests between the two groups of patients one month and 6 months after the TBI. The main analysis will be on an ''intention-to-treat´´ basis. A descriptive analysis of the baseline variables will be made for each treatment group. Logistic regression will be used to estimate the effect of dexamethasone and placebo on GOSE at one month and at 6 months, dichotomized in unfavorable outcome (GOSE 1-6) and favorable outcome (GOSE 7-8). Since the severity of the initial injury will determine significantly the final outcome of the patient, to assess the effect of dexamethasone, efficacy will also be analyzed using the 'sliding dichotomy'. A subgroup analysis will be carried out by stratifying the patients as they present more or less than 10mL of pericontusional edema in the preinclusion CT. We will perform an interim analysis with the patients included during the first year to calculate the conditional power. An independent statistician will blindly perform this analysis. At the same time a safety analysis will be also perfomed. A study with 600 patients would have about 80% power (two sided alpha=5%) to detect a 12% absolute increased (from 50% to 62%) in good outcome.
Susceptibility weighted imaging (SWI) technology has developed in the decade which is being a kind of cerebrovascular disease diagnostic tools in the clinical application, especially for paramagnetic material (such as DNA hemoglobin and hemosiderin) has a high sensitivity. The change of the signal on SWI bases on the change of local oxygenated hemoglobin content in the blood and deaeration hemoglobin content ratio, which can be used to indirectly reflect the hypoxia group oxygen intake fraction (OEF) and cerebral metabolic rate. When the intracranial vascular occlusion, corresponding responsibility vascular blood flow area of brain tissue will occur hypoperfusion, brain tissue will improve the compensation in accordance with its own OEF, causing ischemia area inside the venous drainage of deaeration hemoglobin content ratio increases and the hypointensity on SWI ,which display the asymmetric cortical vessel sign (ACVS). Studies have suggested that ACVS is more prone to early neurological deterioration and has a poor long-term outcome. After recanalization of ischemic stroke, the presence of equal CVS(return to normal) on SWI is associated with a good clinical outcome. In addition, the relationship between ACVS grade and collateral circulation in patients with acute ischemic stroke has been studied. For patients with massive cerebral infarction, the relationship between ACVS on SWI and the clinical prognosis of cerebral edema and cerebral hemodynamics is not completely clear. In this study, the clinical data of patients with massive cerebral infarction will be analyzed to explore the relationship between ACVS, cerebral edema , cerebral hemodynamic and clinical prognosis. Sodium aescinate is widely used in cerebral edema caused by cerebral hemorrhage or cerebral infarction.The main mechanism of sodium aescinate is anti - inflammatory, anti - exudate, anti - oxygen free radical, anti - edema, increase vein tension, improve blood circulation and nerve protection. In this study, investigators will investigate whether the application of sodium aescinate had an effect on ACVS on SWI in patients with massive cerebral infarction. Plasma s100-β, procalcitonin, neutrophil count, serum fibronectin, and endothelin-1 could predict cerebral edema in patients with cerebral infarction, this study will analyze the relationship between these markers and ACVS on SWI in patients with massive cerebral infarction.
This is a non-randomised, open-label, single center-centre, Phase I-II study in patients with newly diagnosed glioblastoma. 5 patients with newly diagnosed glioblastoma are enrolled in the study and will receive an egg powder enriched for antisecretory factor (AF), Salovum, daily from 2 days before concomitant radio-chemo therapy until 14 days after finalisation.The primary aim of the study is to asses safety and feasibility of this regimen.
The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using invasive measurement SPV/PPV (Aisys GE) and noninvasive haemodynamic measurement (ClarSight, Edwards).
The purpose of this study is to test the safety and effectiveness of a single dose of fingolimod in patients with primary spontaneous intracerebral hemorrhage (ICH).
To use machine learning for early detection of malignant brain edema in patients with MCA ischemia
Patient undergoing laparoscopic radical prostatectomy in steep trendelenburg position are at risk to develop complication from brain edema. Ultrasound assessment of optical nerve sheath diameter is a simply, non-invasive method to estimate the increase of intracranial pressure. It is unknown how optical nerve sheath diameter changes after prolonged head down position.
This study aims to investigate the inner mechanism during different dehydration therapies such as mannitol injection and hypertonic saline. The investigators used a self-made near infrared spectroscopy (NIRS) instrument to monitor the physiological changes noninvasively including oxyhemoglobin ([HbO2]), deoxy-hemoglobin ([Hb]), the derived change in blood volume ([tHb]) and water concentration on the forehead of brain edema patients.
The study is to explore the molecular mechanisms underlying the occurrence of malignant cerebral edema (cerebral hernia) after large hemispheric infarction. Acute LHI (<=48h) patients that develop cerebral hernia or not within 5 days post-stroke onset, as well as the healthy controls will be studied. The participants will be followed for up to 6 months post stroke-onset, and their modified Rankin Scale (mRS) will be recorded. A mRS score of 0-4 is considered as a favorable outcome while a score of 5-6 as an unfavorable one.