View clinical trials related to Hematoma.
Filter by:Standard of care for the management of symptomatic chronic subdural hematomas (SDHs) is neurosurgical burr-hole evacuation followed by drainage. Post-operative recurrence rates may be as high as 10 to 20 %. In particular, recurrence rate increases with antiplatelet and anticoagulant therapy. Middle meningeal artery (MMA) embolization has been proposed as a novel treatment of chronic SDH. The aim of this study is to assess the efficacy of MMA embolization in reducing the risk of chronic SDH recurrence at 6 months after burr-hole surgery as compared with standard medical post-operative treatment in patients at high risk of post-operative recurrence.
This study is designed to evaluate the effectiveness of endovascular embolization of middle meningeal artery following evacuation of subdural hematomas (SDHs) to assess rate of recurrence. The historical standard for treatment of subdural hematomas has been surgical evacuation through burr holes or craniotomies. Many of these patients are elderly patients who are high risk surgical candidates. A major concern is SDH recurrence. Recurrences require frequent imaging, and will lead to increased length of hospital stay, increased morbidity,and re-operations. There are increasing number of reports that suggest that a less invasive approach such as endovascular embolization of the middle meningeal artery using standard endovascular materials and techniques may reduce the risk of recurrence. The reported outcomes in the current literature have been very positive when endovascular embolization has been used without surgery or as an adjuvant to surgery. However, there have been no studies directly comparing endovascular embolization following surgical evacuation to assess if this technique can actually reduce the complications of SDHs listed above. The investigators propose to study this treatment process by randomly assigning patients who have undergone surgical evacuation of SDHs into a control and treatment group. The control group will receive standard surgical evacuation of the hematoma. The study group will receive surgical evacuation followed by endovascular embolization.
Although craniotomy provides a more complete evacuation of the acute epidural hematoma, there are insufficient data to support specific surgical treatment method. We aim to perform a multi-center, parallel-group randomized clinical trial to compare the outcome and cost-effectiveness of decompressive craniectomy versus craniotomy for the treatment of traumatic brain injury patients with cerebral herniation undergoing evacuation of an acute epidural hematoma.
This is a multicenter, prospective, and observational real-world study aimed at investigating the current situation of surgical treatments and prognosis for acute epidural hematoma in China, and analyzing the optimization of therapy.
Epileptic seizures are one of the frequent complications in patients with traumatic brain injury; the incidence lies approximately at 20%. Particularly, acute subdural hematoma (aSDH) is one of the most important predictors for epileptic seizures, which is besides other parameters like age, preoperative Glasgow coma scale, cerebral herniation, hematoma volume and time to operation, associated with worse neurological outcome. In a recent systematic review, the mean incidence of epileptic seizures in aSDH was 28%, whereas one retrospective study focusing on EEG-diagnostic reported very high incidence of epileptiform abnormalities on surface EEG in 87% of patients with aSDH, wherefore the question rises, if the incidence of epileptic seizures is underestimated. Despite successful evacuation of subdural hematoma, approximately one third of patients show no clinical improvement without medical explanation. Routinely, surface spot EEG is performed to detect epileptic seizures; however the sensitivity is limited due to the skin-bone barrier and the short duration of recording. Furthermore, surface EEG is not always available, for example during the night or at weekends, which is an additional limitation for the loss of treatment timing as well. Spot surface EEG will record for only 20 to 30 minutes in contrast to continuous EEG recordings that are performed for hours or days. Due to the clinical relevance of epileptic seizures, several studies investigated the benefit of prophylactic antiepileptic treatment. To date, there is only one recommendation from the Brain Trauma Foundation at evidence class II to treat patients with severe traumatic brain injury with prophylactic antiepileptic treatment during the first week. Beyond the interval; there was no clinical benefit for patients selected. Still, there are some limitations´wherefore the clinical use of prophylactic antiepileptic treatment varies between clinicians and countries. At that time, the standard medication was phenytoin which has several side effects, but to date, there are several new intravenous antiepileptic drugs with comparable effect but better safety profile. On the other hand, there was no sifferentiation made between high-risked seizure prone patients, like patients with aSDH, and low-risked patients which is one of the limiting factors to support a general recommendation. Therefore the role of prophylactic antiepileptic treatment is still questionable. In the clinical routine, invasive EEG-electrodes are commonly used to detect epileptic focus. The benefit of those electrodes is the real time analysis in case of seizure occurrence compared to surface EEG. Moreover, therapeutic effect is directly visible through the monitoring. Therefore the idea of this study was to make a real time analysis possible for patient with TBI, particularly aSDH, to have diagnostic and therapeutic real time monitoring detecting subclinical seizures.
All admitted patients diagnosed with unilateral or bilateral chronic subdural hematoma are included into this registry after consent. Clinical condition, radiological details, therapy (intervention/medication treatment/conservative) and outcome are documented. Patient follow-up is documented over at least 24 month with focus on neurological condition (NIHSS), cognitive impairment (MoCA) and quality of life (SF-12 ver. 2).
Chronic Subdural Hematoma (cSDH) is a common hematologic problem particularly in older patients. The purpose of this study is to evaluate the safety and efficacy of middle meningeal artery (MMA) embolization compared to traditional surgical strategies for patients presenting with chronic subdural hematoma (cSDH). Although MMA embolization is minimally-invasive procedure that is routinely used for the treatment of tumors or vascular formations (1), this study investigates the use of an established procedure for a new disease state.
A study to examine the safety and potential effectiveness of human umbilical cord mesenchymal stem cells (hUMSCs) in adults who have suffered spontaneous cerebral hemorrhage in basal ganglia. The hypothesis is that hUMSCs will be safe and can improve neurological function after intracerebral hemorrhage so that improve the prognosis of patients.
Endovascular middle meningeal artery (MMA) embolization is an emerging treatment for chronic subdural hematoma (cSDH). There is preliminary data to suggest that this minimally invasive therapy may be more efficacious and equally as safe compared to conventional, more invasive surgery. This study seeks to assess the safety and efficacy of middle meningeal artery embolization for chronic subdural hematoma as an adjunct to standard treatments, which include medical management and surgical evacuation.
In this prospective, randomized, multicenter trial shall patients with chronic subdural hematoma (cSDH) recruited, who were surgically treated. Initially, we would divide the patients randomized into two groups: Patients with supervised blow-maneuver and without. After surgical treatment of cSDH with insertion of a subdural drain, one group would perform a supervised blow maneuver ("Valsalva maneuver") every hour for five minutes from 10:00 to 20:00. In the other group, the standard care would be performed. The subdural drain would be explanted 2days after operation and a postoperative CT scan would routinely be performed. After hospital discharge, the patient would be rechecked in an ambulant setting and would receive CT scan as clinical standard. Recurrence of hematoma is defined as recurrent hematoma which should be reoperated. After 3 and 6 months we would evaluate the outcome of patients.