Clinical Research Directory

Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA

This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas (cSDH).

Comparative Study of Embolic Agents in Patients With Subdural Hemorrhage Undergoing Middle Meningeal Artery (MMA) Embolization

Single site, prospective, comparative effectiveness pilot trial comparing efficacy and safety outcomes of three embolic materials (particles, liquid embolics, and Wallaby Phenox coils) in MMA embolication for cSDH.

Frontal vs Parietal Eminence Drainage for Chronic Subdural Hematoma

This clinical trial aims to find out whether the puncture site used during minimally invasive surgery with twist-drill puncture and closed-system drainage affects the treatment of chronic subdural hematoma (cSDH). The target population is adults with a unilateral chronic subdural hematoma who need surgical drainage based on their symptoms and imaging findings (CT/MRI). The main questions this study is designed to answer are: * Does the puncture site affect the risk of same-side cSDH recurrence requiring reoperation within 3 months * Does the puncture site affect recovery and key clinical outcomes after surgery (including functional status and postoperative recovery measures) There are two groups, researchers will compare: * Group A: patients receiving puncture at the frontal region vs. * Group B: patients receiving puncture near the parietal eminence to determine whether one puncture site leads to better outcomes than the other. Participants will: * undergo a surgical procedure where, based on random assignment, the puncture site is either frontal or near the parietal eminence; * receive closed-system drainage after a twist-drill puncture; * complete follow-up assessments at discharge, 30 days, 3 months after surgery, which will include symptom review and imaging (CT) evaluations to check hematoma changes and recurrence; * have safety monitoring throughout the study period to record any complications or adverse events.

The CHALLENGER Registry

The study is a multi-center prospective, single-arm, post-market study evaluating the efficacy and radiologic and functional outcomes associated use of the Numen SILK coils for Middle Meningeal Artery (MMA) embolization following Chronic Subdural Hematoma (cSDH) compared to surgical evacuation or medical management alone. Chronic subdural hematoma is a collection of blood between the dural mater and the brain. It typically develops over time in older adults or people on anticoagulant medication. Blood slowly accumulates over time and often becomes encapsulated by a fibrous membrane over weeks or months, which can lead to the gradual development of symptoms. Middle Meningeal Artery embolization (MMAE) through coiling provides a minimally invasive option for cSDH treatment and prevention of reaccumulation and recurrence.

Intra-Arterial Bevacizumab as an Adjunct to Middle Meningeal Artery Embolization for Chronic Subdural Hematoma

This is a Phase 1, open-label, single-center, dose-escalation study evaluating the safety and tolerability of intra-arterial bevacizumab (IA-BEV) given as an adjunct to middle meningeal artery embolization (MMAE) in adults with non-surgical chronic subdural hematoma (cSDH). Up to 18 participants who are already scheduled to undergo MMAE as standard of care will receive a single dose of bevacizumab, delivered directly into the middle meningeal artery immediately before embolization, during the same procedure. Three dose levels (2.0, 3.5, and 5.0 mg/kg) will be tested using a standard 3+3 dose-escalation design to identify the maximum tolerated dose. The study will also collect imaging and blood biomarker data to help understand which patients may benefit most from this combined treatment approach.

Template-Guided Burr-Hole Drainage With Middle Meningeal Artery Coagulation for Chronic Subdural Hematoma

Chronic subdural hematoma is a collection of blood and fluid on the surface of the brain that is common in older adults. Burr-hole drainage is a standard surgical treatment, but the hematoma may come back in some patients and require another procedure.This study will test whether using a patient-specific 3D-printed template to guide burr-hole placement, combined with coagulation of the middle meningeal artery during surgery, can reduce the risk of hematoma recurrence compared with standard burr-hole drainage.Participants with symptomatic chronic subdural hematoma who need surgery will be randomly assigned to one of two groups. One group will receive standard burr-hole drainage. The other group will receive 3D-printed template-guided burr-hole drainage with attempted intraoperative frontal branch of the middle meningeal artery coagulation when it can be safely performed.The main outcome is whether the hematoma comes back and requires another invasive treatment within 3 months after surgery. The study will also assess brain imaging results, neurological recovery, complications, hospital stay, and the feasibility and safety of the 3D-printed template and artery coagulation procedure.

Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas

This is a pragmatic, prospective, multicenter, randomized controlled trial with intention to treat analysis. In which subjects will receive either unilateral or bilateral middle meningeal artery (MMA) embolization using coils for the treatment of unilateral chronic subdural hematomas (cSDH).

Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH)

This study is an open label randomized controlled trial. Patients with a symptomatic Chronic Subdural Hematoma (CSDH) confirmed on radiological imaging, planned for surgery, age over 18, free from other intracranial pathologies and no previous intracranial surgery, will be recruited at time of admission. Patients eligible for inclusion will be randomized to receive treatment with Tranexamic acid (TXA) as an adjunct to surgery or surgery alone. Surgical evacuation will be performed using a single or double burr hole and 24 hours postoperative drainage. The primary endpoint will be recurrent hematoma requiring repeat surgery within 90 days. Secondary outcomes will be modified Rankin Scale at 90 days, EQ-5D-5L, complications and adverse events, and 90-day mortality.

Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma

COMPLEMENT study (ChrOnic subdural hematoMa Patients suppLemented with Embolization of Middle mENingeal artery Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to assess the efficacy and safety of middle meningeal artery embolization for chronic subdural hematoma.

Surgical Management of Chronic Subdural Hematoma: Clinical Outcomes Following Single VS Double Burr Holes Evacuation

This study aims to evaluate and compare the clinical and radiological outcomes of patients with chronic subdural hematoma (CSDH) undergoing surgical evacuation using either single or double burr-hole craniostomy. The comparison focuses on key outcome measures including recurrence rate, postoperative complications, neurological improvement, length of hospital stay, and overall functional recovery, in order to determine the most effective and safe surgical technique.

Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization

Chronic subdural hematomas (CSH) are collections of blood in the subdural space. CSH are becoming the most common cranial neurosurgical condition among adults, and a significant public health problem, due to an increasing use of anticoagulant and antiplatelet medication in an ageing population. Symptomatic CSH, or CSH with a significant mass effect, are treated surgically. However, recurrences are common (10 to 20%). Conservative management (medical) is used in patients who are asymptomatic or have minor symptoms. However, therapeutic failures, requiring surgical treatment, are common. The pathophysiology of CSH involves inflammation, angiogenesis, and clotting dysfunction. Self-perpetuation and rebleeding is thought to be caused by neo-membranes from the inflammatory remodeling of the dura-mater mainly fed by the distal branches of the middle meningeal artery (MMA). There are 13 ongoing registered RCTs in CSH, with the most common covering application of steroids, surgical techniques and tranexamic acid. Further to this, there are trials running on other pharmacological agents, and peri-operative management. Some industrial or academic trials are or will enroll in France in the next year in France. But to our best knowledge, none of these trials will the eventual benefits of the MMA embolization in both cases of medical and/or surgical management, and none will focus on the use of cyanoacrylates (CYA) for this purpose. Preliminary case series and nonrandomized retrospective studies have suggested that MMA embolization alone or as adjuvant therapy to surgery can decrease recurrences. The investigators hypothesize that in both conditions of conservative or surgical managements, endovascular embolization of patients with CSH significantly reduces the risk of recurrence of CSH. The investigators choose the CYA as liquid embolic agent because of the pain and cost of the use of Ethylen Vinyl alcohol copolymer (EVOH) agents and its simplicity to be used.

Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma

The goal of this randomized controlled trial is to evaluate whether the adjuvant application of non-thermal plasma (NTP) during standard surgical drainage of chronic subdural hematoma (cSDH) can reduce the recurrence rate at 6 months. The main questions it aims to answer are: * Does NTP application significantly lower the radiological and clinical recurrence rate of cSDH compared to surgery alone? * Is NTP safe when applied to the subdural space and surgical wound bed? * Does NTP improve functional outcomes and time to hematoma resolution? Participants will be randomly assigned to one of two groups: * Experimental group (n = 20): Standard burr hole drainage or craniotomy plus intraoperative NTP application over the exposed dura mater, the residual membrane, soft tissue layers, and the skin incision. * Control group (n = 20): Standard surgical drainage alone (no NTP). Follow-up includes clinical assessments and computed tomography (CT) scans at 1 week, 3 months, and 6 months post-surgery. The primary outcome is recurrence (symptomatic reaccumulation requiring re-intervention or ≥50% volume increase on CT).

Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are: * Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths? * What is the safety of MMAE and conventional open surgery in these patients? Participants will be asked to: * Share their medical history and undergo physical examinations * Have blood drawn * Have CT scans of the head * Answer questionnaires * Undergo MMAE or conventional open surgery * Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety.

The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma

This study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma

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

EMMA-Can is a prospective randomized open-label, blinded end point (PROBE) study, that will assess the recurrence risk and safety of embolization of the middle meningeal (EMMA) when added to standard of care treatment (surgical drainage) of chronic subdural hematoma (CSDH) compared to surgical treatment alone.

Implementation of an Enhanced Recovery Pathway for Burr-hole Drainage in Patients With a Chronic Subdural Hematoma

A chronic subdural hematoma (cSDH) is a type of intracranial hematoma that primarily affects older adults. The rising incidence of this condition, coupled with the high healthcare burden of this disease, calls for an update of the medical care program. We introduced an enhanced recovery protocol (ERP) at our center for patients undergoing surgical treatment (by means of burr-hole drainage) for a cSDH. Our ERP includes guidelines for treatment decisions (surgery or middle meningeal artery embolization), modifications in surgical techniques, and standardized postoperative management strategies. This study prospectively analyses the safety and efficacy of this enhanced recovery protocol for patients undergoing burr hole drainage of a chronic subdural hematoma. Safety and efficacy outcomes will be compared with outcomes of a historical patient cohort. Safety of the protocol will be measured in terms of recurrence rate (6-month follow-up, primary outcome), complication incidence, and 30-day mortality. Efficacy of the enhanced recovery protocol will be represented by the length-of-stay.

Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma

Chronic subdural hematoma (CSDH) is a frequent condition in neurosurgery, leading to fluid accumulation between the meninges, brain compression, neurological dysfunction, and potentially herniation. The efficacy of treatments and their long-term outcomes remain uncertain, with no established standard. Notably, neuroendoscopy-assisted hematoma evacuation, in contrast to burr-hole drainage, enables direct visualization and thorough removal of the hematoma, thereby minimizing residue, lowering recurrence rates, and shortening drainage duration. This study will undertake a multicenter trial to compare these two methods and determine the superior treatment approach for CSDH.

Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center

The purpose of this study is to evaluate the function of matched pair Aristotle 14 Guidewire and Plato Microcatheter in MMA embolization treatment for chronic subdural hematoma compared to surgeon's preference

Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)

This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile.

A National Study Examining the Most Effective Drainage Method After Burr Hole Evacuation of Chronic Subdural Hematoma

Chronic subdural hematoma (CSDH) is a common disease. The main treatment is neurosurgical evacuation and subsequent hematoma drainage. However, consensus on the optimal drain placement site, and whether the drainage should be active or passive, is lacking. The aim of the current study is to test the hypothesis that 24 hours active subperiosteal drainage is non-inferior to 24 hours passive subdural drainage after single burr hole evacuation of a unilateral CSDH. The study is a multicenter randomized non-inferiority trial encompassing all neurosurgical units in Denmark. Adult patients with symptomatic CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be screened for inclusion. Patients who are not able to give informed consent, and patients with recurrent CSDH, known cerebrospinal fluid abnormalities, and other known brain pathologies will be excluded. Patients with bilateral CSDH will be registered as one case and treated similarly on both sides. Before surgical hematoma evacuation patients will be randomized to 24-hour passive subdural drainage or 24-hour active subperiosteal drainage. The patients included and the two study statisticians will be blinded. The primary outcome is a composite outcome of 90-day mortality and symptomatic CSDH recurrence. Secondary outcomes are 90-day simplified modified Rankin score (smRSq), and complications related to surgery or occurring during admission, including intracerebral hemorrhage due to misplaced drains, acute subdural hematoma, tension pneumocephalus, wound infection, drain seepage, subperiosteal hematoma, thromboembolic events, infections and seizures. Sample size simulations of non-inferiority with a threshold of 7% increased relative risk show that a total of 354 participants will be required to demonstrate a relative risk reduction of recurrent CSDH and mortality of 30% for the cohort receiving active subperiosteal drainage given a stable power above 80% with an alpha of 5%. The study inclusion period is estimated to last 2 years. Ethics approval for inclusion of competent patients has been obtained (N-20240009).

Aspirin Continuation or Discontinuation in Conservative Treatment for Chronic Subdural Hematoma

This clinical study aims to learn about the efficacy and safety of aspirin continuation or discontinuation in conservative treatment for chronic subdural hematoma. All participants received standard conservative treatment for chronic subdural hematoma, with a randomized intervention to either continue or discontinue aspirin administration. By participating in this study, participants can receive additional scientific guidance on aspirin medication management beyond routine conservative treatment, thereby optimizing individualized therapy.

Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy

All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain. Depending on the specific condition patients may also have a surgical procedure, a mini-craniotomy or burr holes where the skull is pierced and the blood clot is drained.

Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation

The goal of this randomized clinical trial is to assess the benefit of early resumption versus late resumption of oral anticoagulation medication in adults with atrial fibrillation undergoing surgery for chronic subdural hematoma. The main questions it aims to answer are: * Does anticoagulation resumption 5 days after surgery as compared to 30 days after surgery result in fewer thromboembolic complications, without increasing the risk for bleeding? * Does anticoagulation resumption 5 days after surgery as compared to 30 days after surgery affect the risk of reoperation, functional outcome, mortality, and healthcare use? Researchers will compare early anticoagulation resumption (5 days) and late anticoagulation resumption (30 days) after chronic subdural hematoma surgery. Participants will either resume the medication 5 days or 30 days after the surgery. The participants will be followed up for 3 months after the surgery.

Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection

The goal of this clinical trial is to test whether infusing bevacizumab into the middle meningeal arteries can be used to treat chronic subdural hematomas (cSDH). The main questions it aims to answer are: * Is bevacizumab infusion safe in cSDH patients? * Is bevacizumab infusion effective in treating cSDH?