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Hematoma, Subdural, Chronic clinical trials

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NCT ID: NCT05472766 Terminated - Atrial Fibrillation Clinical Trials

Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma

ATTAACH
Start date: November 24, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04502745 Terminated - Clinical trials for Chronic Subdural Hematoma

A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation

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

The purpose of this study is to evaluate a less-invasive alternative to the currently available method of removing aging blood in the subdural space.

NCT ID: NCT03353259 Terminated - Clinical trials for Chronic Subdural Hematoma

Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery

Start date: November 28, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Primary objectives of the study are to investigate whether adjuvant treatment in the form of Tranexamic acid (Cyklokapron) and Tocilizumab (RoAcmera) to surgery in patients with chronic subdural hematomaina can: 1. effectively decrease the rate of lesion recurrence requiring re-operation, 2. effectively shorten the time of lesion resolution. Secondary objectives of the study are:1) assess the postoperative functional outcome and quality of life of participants, 2) assess the postoperative mortality of participants, 3) assess the treatment safety data, 4) assess the cure rate of participants.

NCT ID: NCT02362321 Terminated - Clinical trials for Hematoma, Subdural, Chronic

Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma

Start date: January 2007
Phase: Phase 4
Study type: Interventional

Current opinion regarding the use of steroids in the treatment of chronic subdural hematomas are mostly based on observational studies. Here we present data from a prospective randomized pilot study of twenty chronic subdural hematoma (CSDH) patients treated with dexamethasone or placebo for 30 days. Twenty patients with computed tomography (CT)- or magnetic resonance imaging (MRI)-confirmed CSDH were recruited from a single center and randomized in order to receive dexamethasone or placebo as a conservative treatment. Patients affected to the treatment group received oral dexamethasone 12mg/day for three weeks followed by tapering. These patients were followed for 6 months and the rate of success of conservative treatment versus placebo was measured. Parameters such as hematoma thickness and global impression of change were also compared before and after treatment with chi-square tests. Adverse events and complications were documented.

NCT ID: NCT02111785 Terminated - Clinical trials for Chronic Subdural Hematoma

Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma

DECS
Start date: March 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Chronic subdural hematoma (cSDH) is condition where blood has slowly leaked out of small blood vessels surrounding the brain. Over time, the blood may cause a variety of symptoms including headache, confusion, limb weakness, and difficulty speaking. There is currently no agreement among physicians as to the best way to treat this condition. The study hypothesis to be tested was: For patients with unilateral, symptomatic chronic subdural hematoma, there is no difference in clinical outcomes, as measured by achievement of modified Rankin Score of 0-2 at 6 months, between those treated with a 2 week course of oral dexamethasone, compared with those treated with burr hole surgical drainage.

NCT ID: NCT01380028 Terminated - Clinical trials for Chronic Intracranial Subdural Hematoma

Interest of Oral Corticosteroids in the Treatment of Chronic Subdural Hematomas

hemacort
Start date: July 22, 2011
Phase: Phase 3
Study type: Interventional

The chronic subdural hematoma is a common disease in the population over 60 years. For example, in patients over 70 years, it occurs every year 7 new cases per 100,000 people. A chronic subdural hematoma is an accumulation of blood in the intracranial space between brain membrane (dura mater) and the brain. The origin of blood in this area follows a minor brain injury, which causes the rupture of small vessels in the area. During its evolution, the volume of the hematoma increases. After a few weeks, the amount of fluid build-up can compress the brain. That's when clinical symptoms occur: persistent headaches, neurological deficits, seizures, impaired consciousness, cognitive functions (memory loss, impaired intellectual function, or hallucinations, etc.). The compression of the brain may cause impairment of consciousness resulting in more severe cases coma and death. At this stage, a neurosurgical intervention is necessary. Recurrences are numerous (15 to 25% recurrence over six months after neurosurgery). That is why in France, about 20% of medical teams administer a postoperative treatment with corticosteroids to reduce the risk of recurrence. Until now, the potential benefit of this treatment has not yet been confirmed by a clinical study. So the purpose of this research.

NCT ID: NCT00915928 Terminated - Clinical trials for Hematoma, Subdural, Chronic

Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors

KSDH
Start date: July 2009
Phase: N/A
Study type: Interventional

The project aims at investigating if treatment with the Angiotensin Converting Enzyme inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma will decrease the risc of recurrence.