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Hematoma, Subdural, Chronic clinical trials

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NCT ID: NCT05220826 Recruiting - Clinical trials for Chronic Subdural Hematoma

Endovascular Embolization of Chronic Subdural Hematomas After Surgery

ENCLOSURE
Start date: February 11, 2022
Phase: N/A
Study type: Interventional

Chronic subdural hematomas (CSH) are one of the most frequent pathologies in emergency neurosurgical practice. Standard therapy for symptomatic CSH is surgical drainage. However, the recurrence rate after surgery is high (10 to 20% in the most of series, although it has been reported from 2 to 37%). Middle meningeal artery embolization (MMAE) is a promising minimally invasive procedure that has recently been proposed as an alternative or adjunctive treatment to surgery. The investigators hypothesize that early post operative endovascular treatment can reduce the recurrence rate in high-risk patients, improving neurological outcomes by reducing the need for reinterventions, hospitalizations, and post-operative complications. The aim of the investigators is to analyze the efficacy of and safety of early post-surgical embolization of MMA in reducing the risk of CSH recurrence.

NCT ID: NCT05143216 Recruiting - Clinical trials for Chronic Subdural Hematoma

High Concentration Oxygen Therapy for Pneumocephalus in Chronic Subdural Haematoma: A Prospective Observational Study

Start date: May 6, 2021
Phase:
Study type: Observational

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: NCT05079295 Recruiting - Clinical trials for Chronic Subdural Hematoma

Management of Anticoagulants and Antithrombotics in Patients With CSDH

THERCA
Start date: February 20, 2021
Phase:
Study type: Observational

Primary objective of the study will be to compare, up to 6 months after surgery, number of relapses (post operative re-bleeding) or intracerebral hemorrhage (others than subdural hematomas) and thromboembolic or cardiovascular ischemic events, in patients undergoing surgery for chronic subdural hematoma (CSDH). These data will be correlated to the suspension or not of antithrombotics or anticoagulants before surgery or their re-introduction after surgery.

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: NCT04742920 Recruiting - Wounds and Injuries Clinical Trials

The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma (OTEMACS)

OTEMACS
Start date: October 12, 2021
Phase: N/A
Study type: Interventional

Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach might increase the likelihood of resolution and might prevent reaccumulation of Chronic Subdural Hematoma (CSDH). The purpose of the OTEMACS Trial is to assess the safety and effect on recurrence rate and functional outcome of endovascular treatment in patients with CSDH.

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: NCT04573387 Recruiting - Clinical trials for Hematoma, Subdural, Chronic

Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy

ECHO
Start date: December 29, 2020
Phase: N/A
Study type: Interventional

A prospective, multicenter, randomized controlled trial is designed to compare the recurrence rates and clinical outcomes in patients with chronic subdural hematoma using exhaustive drainage or fixed-time drainage after one-burr hole craniostomy.