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Chronic Subdural Hematoma clinical trials

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NCT ID: NCT04759196 Recruiting - Clinical trials for Chronic Subdural Hematoma

Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas

GENESIS
Start date: March 1, 2021
Phase: Phase 4
Study type: Interventional

Some patients with chronic subdural hematomas and transient neurological symptoms do not respond to standard antiepileptic drugs. The investigators think that some of them could have cortical depression rather than epileptic discharges. After an intensive literature review, the investigators found out that some antiepileptic dugs (Lamotrigine, Topiramate) were found to be efficient to treat cortical depression in other conditions (migraine, subarachnoid hemorrhage). In contrast, some other drugs (Levetiracetam) were not proved to be efficient. Knowing that, the investigators want to compare the efficacy of Topiramate against Levetiracetam in two different groups, the NESIS group (based on a NESIS score of 4 or more - increased risk of cortical depression) versus a non-NESIS group (score of 3 or less - increased risk of epileptic discharges).

NCT ID: NCT04750200 Recruiting - Clinical trials for Chronic Subdural Hematoma

Management of CSDH With or Without EMMA- a Randomized Control Trial

EMMA-Can
Start date: August 1, 2021
Phase: N/A
Study type: Interventional

EMMA-Can is an open-label randomized control trial comparing the recurrence risk in patients with chronic subdural hematoma (CSDH) undergoing standard of care treatment (surgical drainage and/or medical management) with or without embolization of the middle meningeal (EMMA).

NCT ID: NCT04725851 Recruiting - Recurrence Clinical Trials

High Concentration Oxygen for Pneumocephalus After Evacuation of Chronic Subdural Haematoma

HOPE
Start date: July 26, 2022
Phase: N/A
Study type: Interventional

Normobaric oxygen therapy was shown to be effective in reducing post craniotomy pneumocephalus. Theoretical assessment of normobaric oxygen therapy in treating pneumocephalus has shown that a higher level of oxygen concentration will significantly decrease the time for absorption of pneumocephalus. The therapeutic efficacy is not fully established in patients with chronic subdural hematoma after burr hole drainage. Both radiological outcomes and clinical outcomes would be evaluated.

NCT ID: NCT04607447 Recruiting - Clinical trials for Chronic Subdural Hematoma

Low Intracranial Pressure Treatment Strategies for Chronic Subdural Hematoma Patients

CSDH-LP
Start date: August 4, 2020
Phase: N/A
Study type: Interventional

The proportion of the elderly population is increasing rapidly. Chronic subdural hematoma has become the most common cause of surgery in neurosurgery for elderly patients. The standard treatment for cSDH is mostly surgery. Clinically, we often encounter elderly patients with certain underlying diseases or organ dysfunction, especially preexisting cardiovascular disease or medication history like anticoagulant or antiplatelet drugs, resulting in poor surgical tolerance, high risk during anesthesia and hematoma recurrence. At present, the mechanism of cSDH is not completely clear. Our previous observational studies had shown significant correlation between cSDH and intracranial hypotension. So we would like to conduct a randomized, controlled, multi-center clinical study to explore the effectiveness and safety of low intracranial pressure treatment strategies for patients with chronic subdural hematoma.

NCT ID: NCT04574843 Recruiting - Clinical trials for Chronic Subdural Hematoma

Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

The study evaluates the clinical and imaging outcome of middle meningeal artery (MMA) embolization with liquid embolic agent for treatment of chronic subdural hematoma (CSDH)

NCT ID: NCT04372147 Recruiting - Clinical trials for Chronic Subdural Hematoma

Embolization of the Middle Meningeal Artery for the Prevention of Chronic Subdural Hematoma Recurrence in High Risk Patients (EMPROTECT)

EMPROTECT
Start date: June 22, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04095819 Recruiting - Clinical trials for Chronic Subdural Hematoma

Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)

Start date: June 19, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04065113 Recruiting - Clinical trials for Chronic Subdural Hematoma

Middle Meningeal Artery Embolization for Chronic Subdural Hematoma

Start date: September 19, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04060186 Recruiting - Clinical trials for Chronic Subdural Hematoma

Postoperative Balloninflation After Evacuation of cSDH

BANISH
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03956368 Recruiting - Clinical trials for Chronic Subdural Hematoma

Efficacy of Atorvastatin in Chronic Subdural Haematoma

REACH
Start date: January 9, 2020
Phase: Phase 3
Study type: Interventional

This prospective, double-blind, randomized, placebo-controlled study aims to evaluate the efficacy and safety of atorvastatin in patients with chronic subdural haematoma. The degree of disability or dependence in daily activities, as well as surgical intervention or recurrence, of the treatment and control groups will be compared.