View clinical trials related to Hematoma, Subdural, Chronic.
Filter by:Chronic subdural hematomas are frequent neurosurgical issues that are most often treated with burr hole craniectomies to drain the subdural fluid. At the chronic stage, a subdural hematoma is more liquified and easily washed out through burr hole openings. However, it often requires frequent imaging and monitoring to ensure that fluid does not reaccumulate in the subdural space, that the washout was adequate, and that further intervention/repeat intervention is not required, particularly if the patient develops acute changes in neurologic status or lacks improvement in initial symptomatology. Therefore, these patients require multiple repeated CT head images during their inpatient and post-operative follow-up course. This leads to high radiation doses to patients and high-cost burden. The Longeviti ClearFit Cover was developed to allow for ultrasound imaging through the implanted cover. The skull's acoustic properties prevent ultrasound from being used through the bone, therefore limiting its use in post-operative neurosurgical patients. Using ultrasound would remove the need for high radiation doses with CT, could be done very quickly and easily at bedside or in the clinic to check subdural space or ventricle size, and is much lower cost. This ClearFit implant would be utilized in place of a burr hole cover, typically titanium, that is implanted in most other cases. The aim of this study is to prospectively assess patients with surgically treated chronic subdural hematomas via craniectomy that have the craniectomy site covered with the Longeviti ClearFit, compared retrospectively to a matched cohort of patients that had their craniectomy site for the same procedure covered with the typically used titanium/metal. This will allow us to determine if this new implant results in reduced need for repeated CT imaging by utilizing bedside clinician-performed ultrasound and reduces overall cost for patients.
A prospective multicenter cohort study was designed to compare the differences in complications with YL-1 Needle Puncture versus Bulr-hole Craniotomy (BHC) with postoperative Exhaustive Drainage strategy for patients with Chronic Subdural Hematoma.
Chronic subdural hematoma (cSDH) is one of the most common problems treated by neurosurgeons, particularly as the population ages. While often dismissed as a benign problem, it has become clear that cSDH is associated with worse long term functional and cognitive outcomes compared to matched controls. Though surgical techniques for treatment of cSDH are becoming more effective and safe, a persisting problem of fluctuating, stroke-like neurological deficits has re-emerged. Such deficits are not always directly related to hematoma mass effect and not always relieved with surgical decompression, but can result in prolonged hospital course, additional workup, and sometimes even additional invasive treatments. While the cause of such events is unknown, we recently documented for the first time that massive waves of spreading depolarization can occur in these patients and were closely linked to such neurologic deficits in some patients. In the current study, we plan to expand on these preliminary findings with rigorous, standardized application of post operative subdural electrocorticography monitoring, pioneered at our institution to detect SD. We also plan to build on our large retrospective analysis estimating the overall incidence of such deficits in cSDH patients by assessing multiple proposed risk factors for SD. In addition, for the first time, we will assess the short- and long-term consequences of cSDH and SD with detailed functional, cognitive, and headache related outcome measurement. These assessments are based on several remarkable cases we have observed with time-locked neurologic deterioration associated with recurrent SD. This study qualifies as a mechanistic clinical trial in that we will be prospectively assigning patients to the intervention of SD monitoring and assessing outcomes related to the occurrence of SD. This constitutes the application of a novel measure of brain signaling and assessing biomarkers of these physiologic processes of SD. These studies will provide critically needed information on this novel mechanism for neurologic deficits and worse outcomes after cSDH evacuation. Upon successful completion, we would identify a targetable mechanism for poor outcomes that occur commonly in patients with cSDH. This overall strategy offers the opportunity to radically improve the care of patients with cSDH by focusing on clinical trials of pharmacologic therapies for neurologic deficits in patients with cSDH.
A prospective, multicenter, randomized controlled trial is designed to evaluate the safety of nerve block anesthesia combined with sedative anesthesia versus general anesthesia during burr hole craniostomy with drainage for chronic subdural hematoma.
A prospective, multicenter, case control trial is designed to compare difference in dietary and nutritional factors in patients with and without chronic subdural hematoma.
To determine the utility of tissue plasminogen activator (tPA) in the clearance of chronic subdural hematomas (CSDH). Intra-catheter tPA will be administered during surgical procedure and allowed to break down blood clot to assist with removal/drainage during twist drill craniostomy procedure.
Subdural hematoma (SDH) is a common disorder that typically results from head trauma and has increased in prevalence in recent decades. Acute subdural hematomas (aSDH) are found in up to one-third of patients with severe traumatic brain injury and are associated with an unfavorable outcome in the majority of cases. Chronic subdural hematomas (cSDH) commonly occur in the elderly population which has highest risk for developing cSDH with or without minor head injuries. The combination of the aging population, higher incidence of disease in progressively older patients, and high morbidity and mortality renders SDH a growing problem within Canada with significant health-systems burden. SDH commonly recurs even after successful surgical drainage. Atrial fibrillation (AF) is one of the most common medical comorbidities in patients with cSDH, especially in the elderly, with an expected doubling of its prevalence by the year 2030. Patients with AF are at recognized risk for stroke, so anticoagulation is indicated for almost all patients. Anticoagulation is held prior to SDH drainage to minimize the risk of intraoperative and early postoperative bleeding. After surgery, the risk of SDH recurrence must be balanced against the risk of thromboembolic events such as stroke when deciding the timing of resuming anticoagulation. Currently the decision on when to restart anticoagulation after SDH is made by clinicians on an individual patient basis without any high-quality evidence to guide this decision. The two most common approaches are: 1) early resumption of anticoagulation after 30 days of diagnosis or surgery; and 2) delayed resumption of anticoagulation after 90 days of diagnosis or surgery. However, which of these approaches leads to the best functional outcomes for patients is unclear. Our pilot RCT will test the feasibility of comparing these 2 approaches in a larger multicenter RCT.
Chronic subdural hematoma (CSDH) is a very common hemorrhagic disease of the nervous system, accounting for about 10% of hemorrhagic strokes. The incidence rate of elderly people over 65 years old is 58.1/100,000, and the incidence rate is increasing year by year, and it may reach 121/100,000 by 2030. At present, the specific pathogenesis of CSDH is still unclear. Although it has been clinically confirmed that a part of CSDH can be absorbed by itself, and some drugs such as atorvastatin can speed up the process, surgical treatments such as cranial craniotomy or cranial drilling hematoma removal are still the only options for patients with CSDH. Lymphatic circulation spreads throughout most tissues of the human body, assists in removing metabolic wastes in the interstitium, maintains body fluid homeostasis, and plays a role in immune response and immune surveillance. For a long time, the central nervous system has been considered as an immune-privileged organ, that is, the central nervous system does not have the presence of the lymphatic system. Until 2015, Louveau et al. used immunofluorescence staining and other techniques to find functional lymphatic ducts adjacent to the dural venous sinuses in the mouse brain when looking for the channels for T cells to enter and leave the meninges, confirming the first intracranial meningeal lymphatic vessels. (mLVs), and found that mLVs express the classic markers of lymphatic endothelial cells (LECs), namely VEGFR3, prostate homeobox 1 (PROX 1), podoplanin, lymphatic endothelial markers transparent Ronidase receptor-1 (LYVE-1), etc. Relevant studies have confirmed that meningeal lymphatic vessels can drain interstitial fluid (ISF), macromolecular substances and immune cells out of the skull, providing a new drainage pathway for the excretion of metabolic waste from the central nervous system. Subsequent studies have confirmed that mLV is involved in the pathophysiological process of a series of neurological diseases such as Alzheimer's disease (AD), traumatic brain injury (TBI), and subarachnoid hemorrhage (SAH). This phenomenon suggests that mLVs play an important role in central nervous system diseases.
Chronic subdural hematomas (CSH) are collections of blood in the subdural space. CSH are becoming the most common cranial neurosurgical condition among adults, and a significant public health problem, due to an increasing use of anticoagulant and antiplatelet medication in an ageing population. Symptomatic CSH, or CSH with a significant mass effect, are treated surgically. However, recurrences are common (10 to 20%). Conservative management (medical) is used in patients who are asymptomatic or have minor symptoms. However, therapeutic failures, requiring surgical treatment, are common. The pathophysiology of CSH involves inflammation, angiogenesis, and clotting dysfunction. Self-perpetuation and rebleeding is thought to be caused by neo-membranes from the inflammatory remodeling of the dura-mater mainly fed by the distal branches of the middle meningeal artery (MMA). There are 13 ongoing registered RCTs in CSH, with the most common covering application of steroids, surgical techniques and tranexamic acid. Further to this, there are trials running on other pharmacological agents, and peri-operative management. Some industrial or academic trials are or will enroll in France in the next year in France. But to our best knowledge, none of these trials will the eventual benefits of the MMA embolization in both cases of medical and/or surgical management, and none will focus on the use of cyanoacrylates (CYA) for this purpose. Preliminary case series and nonrandomized retrospective studies have suggested that MMA embolization alone or as adjuvant therapy to surgery can decrease recurrences. The investigators hypothesize that in both conditions of conservative or surgical managements, endovascular embolization of patients with CSH significantly reduces the risk of recurrence of CSH. The investigators choose the CYA as liquid embolic agent because of the pain and cost of the use of Ethylen Vinyl alcohol copolymer (EVOH) agents and its simplicity to be used.
Patients with a chronic subdural hematoma (cSDH), that is, a blood accumulation between two meninges developing over a long period of time, often have recurrent bleedings after an initial operation. The study aims to show that additional surgery reduces the risk of recurrent bleeding. The additional procedure aims to block small blood vessels in the skull with tiny plastic particles. The small blood vessels are embolized using X-rays and a contrast medium and a fine tube that is inserted into the diseased vessels of the head via the groin. Patients of full age who have undergone burr hole trepanation as a first operation, i.e. a blood drain through a hole in the cranial cavity, can participate in the study. Participating patients are randomly assigned to a control group with treatment according to clinical routine or a treatment group with an additional occlusion of the blood vessels in the skull. In addition, patients can consent to a genetic test to determine the relationship between a coagulation factor and the risk of recurrence of the hematoma. In order to record the test results, check-up examinations are carried out after one and three months.