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Hematoma, Subdural, Chronic clinical trials

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NCT ID: NCT06323434 Not yet recruiting - Clinical trials for Chronic Subdural Hematoma

Spinal CSF Leaks in Chronic Subdural Hematoma

SPICE
Start date: April 2024
Phase:
Study type: Observational

Background: Chronic subdural hematoma (cSDH) is a type of intracranial bleeding, predominantly affecting the elderly and males, with an estimated incidence of 8/100.000. The collection of subdural fluid expands slowly, leading eventually to brain tissue compression that results in neurological impairment such as seizures, cognitive decline, and paresis. Most patients need neurosurgical evacuation of the blood to improve and to prevent further, possibly permanent deterioration. Evidently, the cause of such a bleeding must be investigated and if possible treated, or preventive strategies need to be installed if possible. Spinal cerebrospinal fluid (CSF) leaks are a known cause of cSDH but are widely underdiagnosed in this population. The spinal CSF leak causes CSF loss that leads to intracranial hypotension, expansion of intracerebral veins, and traction to the brain and the surrounding tissues. A cSDH is a severe complication of such a leak and occurs in about 30% of all cases with a predominance among the elderly. It is crucial to identify these patients with a spinal leak as treatment pathways differ essentially from patients without a leak. Some smaller studies indicated a prevalence of spinal CSF leaks among cSDH patients of 30% to 80% depending on selection criteria (age, extend of cSDH). Notably, the entity of the CSF-venous fistula, that has been discovered as recent as 9 years ago, and that by now is accounting for 20-25% of all spinal leaks, has not been considered in previous research on cSDH and spinal CSF leaks. Currently, there is no prospective data on spinal CSF leaks in patients with cSDH. Establishment of such data is crucial to improve diagnostic and therapeutic algorithms for spinal CSF leaks in patients with cSDH. Objective: To prospectively assess the prevalence of spinal CSF leaks in patients with cSDH Methods: This is a prospective observational, monocentric study on patients admitted due to cSDH to the Department of Neurosurgery at the Medical Center of the University of Freiburg. Treatment and diagnostic procedures will follow standard protocols. The number of spinal CSF leaks will be assessed to generate the prevalence of spinal CSF leaks in this patient cohort. Furthermore, clinical data, the specific type of the CSF leak, and imaging parameters are assessed systematically to estimate the diagnostic value of these measures.

NCT ID: NCT06274580 Not yet recruiting - Clinical trials for Subdural Hematoma, Chronic

Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Embotrial-1 is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE) to assess the superiority of MMA embolization compared to conservative treatment. The intervention group is MMA embolization and comparator control group is the conservative management with best medical treatment. Patients are randomized 1:1.

NCT ID: NCT06181994 Recruiting - Clinical trials for Chronic Subdural Hematoma

Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)

MESH
Start date: December 5, 2023
Phase:
Study type: Observational

This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile.

NCT ID: NCT06163547 Not yet recruiting - Clinical trials for Chronic Subdural Hematomas

Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

STORMM
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Chronic Subdural Hematomas (cSHD) are common, and due to cerebral compression, often result in neurological impairment and reduced consciousness. Surgery is typically performed once neurological symptoms develop. Recent studies suggest that arteries nourished by the middle meningeal artery (MMA) may be responsible for hematoma progression and that MMA embolization is clinically useful. There is less evidence, that embolization of MMA also may be a treatment option for individuals without surgical treatment. The investigators propose a multicentre study to investigate both potentials: (1) Assessment of efficacy of embolization after surgery to reduce recurrence and improve outcomes by conducting a randomized trial (randomization arms; Arms 1 and 2), (2) Assessment of embolization-alone efficacy when surgery is contraindicated or refused (embolization-only arm, Arms 3 and 4).

NCT ID: NCT06134206 Completed - Clinical trials for Chronic Subdural Hematoma

Burr Hole Ultrasound Study

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Chronic subdural hematoma (CSDH) is commonly managed through burr hole evacuation. This study evaluates the feasibility of trans burr hole sonography as an alternative postoperative imaging modality. A pilot study on 20 patients who underwent burr hole surgery for CSDH was therefore planned. Postoperative imaging included both CT and sonographic examinations through the burr hole. We assessed the ability to measure residual subdural fluid thickness sonographically compared to CT.

NCT ID: NCT06127615 Not yet recruiting - Clinical trials for Chronic Subdural Hematoma

The Efficacy of the Longeviti ClearFit Implant in Craniectomies for Post-Operative Monitoring in Chronic Subdural Hematomas

Start date: November 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06072053 Recruiting - Clinical trials for Chronic Subdural Hematoma

YL-1 Needle Puncture vs BHC With Postoperative Exhaustive Drainage for CSDH

NEBULA
Start date: December 22, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT05900557 Not yet recruiting - Clinical trials for Chronic Subdural Hematoma

Neurologic Deficits and Recovery in Chronic Subdural Hematoma

Start date: March 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05888389 Not yet recruiting - Anesthesia Clinical Trials

Nerve Block Anesthesia Combined With Sedative Anesthesia Versus General Anesthesia in Surgery for CSDH

Start date: March 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05599217 Recruiting - Clinical trials for Chronic Subdural Hematoma

Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)

DISH
Start date: March 13, 2023
Phase:
Study type: Observational

A prospective, multicenter, case control trial is designed to compare difference in dietary and nutritional factors in patients with and without chronic subdural hematoma.