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Chronic Subdural Hematoma clinical trials

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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.

NCT ID: NCT03831997 Recruiting - Clinical trials for Chronic Subdural Hematoma

Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence

Start date: January 17, 2019
Phase:
Study type: Observational

This study aims to reduce the recurrence rate of chronic subdural hematomas (CSDH) by manipulating the post-operative intravenous fluid use. The hypothesis relies on the relationship between osmolality and volume changes related to osmolality. We will be administering dextrose 5% in 1/4 normal saline (D5 1/4NS) post-operatively to induce brain expansion which can take up the residual CSDH space, to help reduce recurrence rate.

NCT ID: NCT03788005 Active, not recruiting - Clinical trials for Chronic Subdural Hematoma

GET-UP Trial: Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas

GET-UP
Start date: April 7, 2019
Phase: N/A
Study type: Interventional

Compare rates of medical complications, recurrence and outcome in 2 randomized groups of patients with surgical chronic subdural hematomas. The intervention group will be assigned to early mobilization (within 12 hours of the surgical procedure). The control group will be assigned to bed rest for 48 hours.

NCT ID: NCT03666949 Recruiting - Clinical trials for Chronic Subdural Hematoma

General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

This study compare general anesthesia versus locoregional anesthesia for evacuation of chronic subdural hematoma. Half of participant will be operated under general anesthesia, while the other half will be operated under locoregional anesthesia.

NCT ID: NCT03447327 Completed - Clinical trials for Chronic Subdural Hematoma

Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma

Start date: March 5, 2014
Phase: N/A
Study type: Interventional

Aim of the work: Is to evaluate the prognosis of single burr hole under local anesthesia in management of CSDH according to clinical picture, risk factors, and age.

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: NCT03307395 Completed - Clinical trials for Chronic Subdural Hematoma

Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma

Start date: October 31, 2017
Phase: N/A
Study type: Interventional

Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach has been attempted with the goal of eliminating the arterial supply to the vascularized membrane. The investigators have recently presented the first known case series of MMA embolization as upfront treatment for cSDH in lieu of surgical evacuation (publication pending). Five patients underwent successful embolization of the MMA with subsequent reduction in size or complete resolution of cSDH with no peri-procedural complications. The purpose of this study will be to evaluate the safety and efficacy of MMA embolization compared to traditional surgical management for symptomatic, chronic, and medically refractory SDH. MMA embolization is an established procedure used routinely for treatment of tumors or vascular malformations; this study investigates the use of an established procedure for a new disease. The investigators hypothesize that MMA embolization will afford a particularly fragile patient population an alternative to invasive and morbid neurosurgical intervention.