Middle Meningeal Artery Embolization for Subdural Hematoma (EMMA-Can Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of Manitoba
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing whether an additional procedure can help prevent brain bleeds in patients who have already received usual care. The goal is to see if this extra step can reduce the risk of the brain bleed coming back.
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is Middle Meningeal Artery Embolization a promising treatment for Subdural Hematoma?Yes, Middle Meningeal Artery Embolization is a promising treatment for Subdural Hematoma. It is a new and less invasive option that is gaining popularity and has shown positive results in treating this condition.78111314
What safety data exists for Middle Meningeal Artery Embolization in treating subdural hematoma?The safety of Middle Meningeal Artery Embolization (EMMA) for treating chronic subdural hematoma has been evaluated in several studies. It is considered a minimally invasive and potentially safe procedure. Systematic reviews and clinical experiences have been conducted to assess its safety and effectiveness. However, more studies are needed to compare the safety of different embolic materials used in the procedure.69101214
What data supports the idea that Middle Meningeal Artery Embolization for Subdural Hematoma is an effective treatment?The available research does not provide any data on Middle Meningeal Artery Embolization for Subdural Hematoma. The studies focus on different treatments for conditions like neoplastic meningitis and meningeal carcinomatosis, which are unrelated to subdural hematoma. Therefore, there is no information here to support the effectiveness of Middle Meningeal Artery Embolization for Subdural Hematoma.12345
Eligibility Criteria
This trial is for patients with chronic subdural hematoma (CSDH) who can function independently (Modified Rankin Scale ≤2), have a CT scan that allows vascular access for the procedure, and symptoms like headache or cognitive issues due to CSDH. It's not for those with CSDH from conditions like tumors, severe kidney problems, pregnancy, or life expectancy under 6 months.Inclusion Criteria
I can carry out all my usual duties with slight disability.
I need surgery for a brain condition causing symptoms like headaches or seizures.
Exclusion Criteria
I am not pregnant and do not have severe kidney problems.
Treatment Details
The EMMA-Can study tests if adding embolization of the middle meningeal artery (EMMA) to standard treatments reduces recurrence in CSDH patients. Participants are randomly chosen to receive either just standard care or standard care plus EMMA.
2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional ArmExperimental Treatment1 Intervention
Patients randomized to the interventional arm will undergo institutional standard of care treatment (surgical drainage and/or medical management for the CSDH as per the standard of care in the institution. These patients will then undergo EMMA within 48 hours after finishing the surgical drainage. The embolic agent and use of general anesthesia vs conscious sedation will be left to operators' preference and the institutional protocol. All patients will be followed as per the institutional standard of the care. Any peri-procedural complications and change in clinical status will be recorded.
Group II: Control ArmActive Control1 Intervention
Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage and/or medical management for the CSDH.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of ManitobaWinnipeg, Canada
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Who is running the clinical trial?
University of ManitobaLead Sponsor
References
Quantitative distribution of 131I-labelled monoclonal antibodies administered by the intra-ventricular route. [2019]In a preliminary study in one patient [111In]DTPA was injected into the lateral ventricle and at the same time [99mT]DTPA into the lumbar sac. The 111In distributed freely throughout the CSF but the concentration of 99mTc in the ventricles remained consistently low. In the second phase of the study three patients with tumours confined to the neuraxis were treated with 20-50 mCi 131I-labelled monoclonal antibodies administered into the lateral ventricle via Ommaya reservoirs. Quantitative distribution of radio-labelled antibody was assessed at intervals up to 8 days post injection. In each case there was rapid distribution to all parts of the neuraxis with 38-68% of total CNS counts remaining in the head and 13-39% in each of the upper and lower half spine areas. The t1/2 for total CNS counts were 31.5, 19.8 and 15.5 h. There was no clear evidence of tumour localization and no neurological toxicity. These patients demonstrate that radiolabelled monoclonal antibodies can be given safely via Ommaya reservoirs and that in order to obtain optimal distribution throughout the CSF this should be the preferred method of administration. Further trials in patients with minimal disease are warranted.
Clinical outcome in aggressively treated meningeal carcinomatosis. [2022]To critically evaluate the clinical outcome of patients with cytologically proved meningeal carcinomatosis and to identify factors associated with an improved outcome.
Carcinomatous meningitis in solid tumours. [2022]Carcinomatous meningitis (CM) is an uncommon but devastating complication of malignancy. The management is controversial and clear recommendations cannot be made because: 1) Most series include patients with CM that has arisen from different primary malignancies which are associated with different median survival intervals. 2) There have been no prospective randomised investigations of treatment modalities in patients with CM from a particular tumour type. 3) The definition of response varies from one report to another so that some response rates refer to cytological changes in the CSF while others take clinical, cytological and biochemical parameters into account. 4) Reports include patients with and without parenchymal metastases and the natural history of carcinomatous meningitis in the two situations may differ. The median survival of solid tumour carcinomatous meningitis (excluding leukaemia and lymphoma) is approximately 2-3 months and patients with breast cancer have the longest survival (median 3 months). Currently patients are treated with radiotherapy to part or all of the neuraxis with either intrathecal or intravenous chemotherapy but the relative contribution of these modalities to survival or quality of life remains unknown. Approximately 50% of patients with carcinomatous meningitis die from other causes, including systemic disease. The two most important endpoints for the patient, neurological improvement and overall survival, are seldom used in isolation in the literature. Many reports have focused on surrogate markers of response, namely biochemical and cytological data points but the correlation between clinical status and these parameters is poor because of differences between lumbar and ventricular CSF and disturbances of CSF flow in CM. The current literature does not provide clear guidelines for the treatment of this condition. Multicentre, prospective, randomised trials should be conducted that address questions of most relevance to the patient, namely neurological status and overall survival.
Intrathecal chemotherapy for patients with meningeal carcinomatosis. [2013]Meningeal carcinomatosis (MC) is increasing, and these patients have a poor prognosis. We analyzed the effects of intrathecal (IT) chemotherapy for these patients.
Route of intracerebrospinal fluid chemotherapy administration and efficacy of therapy in neoplastic meningitis. [2013]A study was undertaken to determine whether route (intraventricular vs intralumbar) of intracerebrospinal fluid (intra-CSF) drug administration influences progression-free survival in the treatment of patients with neoplastic meningitis, which occurs in 1% to 5% of patients with known cancer. Currently available treatment options result in modest responses, which is in part a reflection of obstacles to drug delivery into the leptomeningeal space.
Safety and Effectiveness of Embolization for Chronic Subdural Hematoma: Systematic Review and Case Series. [2020]Embolization of the middle meningeal artery (MMA) has emerged as a minimally invasive means of managing subdural hematoma. The purpose of this study was to systematically review the literature on the safety and effectiveness of this treatment and to share our clinical experience.
[Middle meningeal artery embolization for chronic subdural haematoma. Case series and literature review]. [2021]Middle meningeal artery embolization as primary method for treatment of chronic subdural hematomas became more popular in past decade. There are few large case series (>150 patients) and literature reviews characterizing advantages and drawbacks of endovascular treatment and technical features of surgeries. In this manuscript, the authors report 11 patients with chronic subdural hematoma scheduled for middle meningeal artery embolization and review the literature data on this issue.
Middle Meningeal Artery Embolization for Chronic Subdural Hematoma Using N-Butyl Cyanoacrylate With D5W Push Technique. [2022]Middle meningeal artery (MMA) embolization has been recognized as a promising treatment for patients with subdural hematoma (SDH).
Onyx Versus Particles for Middle Meningeal Artery Embolization in Chronic Subdural Hematoma. [2023]Middle meningeal artery (MMA) embolization has recently emerged as a treatment option for chronic subdural hematoma (cSDH). It is considered a simple and potentially safe endovascular procedure.
Outcomes of Particle versus Liquid Embolic Materials Used in Middle Meningeal Artery Embolization for the Treatment of Chronic Subdural Hematoma. [2023]Early evidence suggests that middle meningeal artery (MMA) embolization is an efficacious minimally invasive neuroendovascular technique for the management of chronic subdural hematoma (cSDH). Particle and liquid embolic materials are commonly used to embolize the MMA; however, studies comparing the safety and outcomes between these 2 materials are limited.
Embolic Agent Choice in Middle Meningeal Artery Embolization as Primary or Adjunct Treatment for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis. [2023]Middle meningeal artery embolization is an emerging treatment option for chronic subdural hematomas.
Grading Embolization of Middle Meningeal Artery for Chronic Subdural Hematoma. [2023]Embolization of middle meningeal artery (EMMA) is a relatively new treatment for chronic subdural hematoma (CSDH). To date, an objective method that assesses or describes the extent of EMMA for the treatment of CSDH does not exist. Recently, the concept of a novel grading scale for EMMA in patients with CSDH has emerged. However, this has not been applied to a clinical case setting and inter-rater reliability has not yet been studied. The purpose of this study was to validate the grading scale in clinical practice and to assess for inter-rater reliability.
Middle meningeal artery embolization without surgical evacuation for chronic subdural hematoma: a single-center experience of 209 cases. [2023]Middle meningeal artery (MMA) embolization is a minimally invasive treatment option for new and recurrent chronic subdural hematomas (cSDH).
A systematic review of middle meningeal artery embolization for minimally symptomatic chronic subdural haematomas that do not require immediate evacuation. [2023]Embolization of the Middle Meningeal Artery (EMMA) is an emerging treatment option for patients with Chronic Subdural Haematoma (CSDH).