Clinical trials: Chronic Subdural Hemorrhage (cSDH)
Chronic Subdural Hematomas
PHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial
This is a prospective, randomized, controlled, open-label, blinded endpoint (PROBE) clinical investigation in which patients with non-emergent chronic subdural hematoma (cSDH) requiring treatment will be randomized (1:1) to…
- Trial name
- PHILFIRST (NCT07576998)
- Testing
- PHIL™ (Precipitating Hydrophobic Injectable Liquid), Surgical evacuation
- Volunteers
- 475 people
- Sponsor
- Microvention-Terumo, Inc.
Chronic Subdural Hematoma
Middle Meningeal Artery Embolization for Chronic Subdural Hematoma
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…
- Trial name
- NCT04065113
- Testing
- Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA), Drainage of Subdural Hematoma
- Where
- United States
- Sponsor
- Washington University School of Medicine
Subdural Hematoma, Subdural Hematoma, Chronic
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
The aim of the study is to proof the effectiveness of Histoacryl® on preventing recurrence or progression of subdural hematoma after embolization of the middle meningeal artery.
- Trial name
- HARMONY (NCT07258069)
- Testing
- Histoacryl®
- Where
- 6 sites in Japan
- Volunteers
- 178 people
- Sponsor
- Aesculap AG
Chronic Subdural Hematoma, cSDH
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.
- Conditions
- Chronic Subdural Hematoma, cSDH, Chronic Subdural Hematomas
- Trial name
- iCURE cSDH (NCT07214623)
- Testing
- Neuro endovascular embolic coil
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- Kaneka Medical America LLC
Chronic Subdural Hemorrhage (cSDH)
Chronic Subdural Hematoma Embolization With Detachable Coils
This is a prospective, multi-center, post market registry study designed to evaluate the safety and efficacy of treatment with Balt coils in patients with chronic subdural hematoma (cSDH).
- Trial name
- SEED (NCT07291427)
- Testing
- Balt coils: (Balt USA, LLC), MMA embolization
- Where
- 5 sites in United States
- Volunteers
- 150 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Chronic Subdural Hematomas
Prospective MMA Embolization Registry
Chronic subdural hematoma (cSDH) is a common condition, particularly in older adults, that can substantially impair patients' quality of life, functional independence, and neurological well-being.
- Trial name
- PRO-EMMA (NCT07626671)
- Testing
- Middle Meningeal Artery Embolization
- Volunteers
- 100 people
- Sponsor
- Charite University, Berlin, Germany
Chronic Subdural Hematoma
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.
- Trial name
- NCT07240454
- Testing
- Aspirin Continuation, Aspirin Discontinuation
- Where
- 2 sites in China
- Volunteers
- 143 people
- Sponsor
- Tao Liu
Chronic Subdural Hematoma
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…
- Trial name
- (COAST) (NCT07715656)
- Testing
- embolization therapy Bilateral, embolization therapy Unilateral
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Lahey Clinic
Chronic Subdural Hematoma, Anticoagulant-induced Bleeding
Management of Anticoagulants and Antithrombotics in Patients With CSDH
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…
- Conditions
- Chronic Subdural Hematoma, Anticoagulant-induced Bleeding, Thromboembolic Stroke, Cardiovascular Stroke
- Trial name
- THERCA (NCT05079295)
- Testing
- CSDH evacuation
- Where
- Italy
- Volunteers
- 400 people
- Sponsor
- University Hospital of Ferrara
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…
- Trial name
- EMMA-Can (NCT04750200)
- Testing
- Embolization of the Middle Meningeal Artery
- Where
- Canada
- Volunteers
- 192 people
- Sponsor
- University of Manitoba
Subdural Hematoma
MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma
The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the NeoCast Embolic System for treatment of symptomatic subacute or chronic subdural hematoma (SDH)…
- Trial name
- RADIANT (NCT07541404)
- Testing
- NeoCast Embolic System, Onyx LES, an FDA-Approved Commercial Liquid Embolic
- Where
- 2 sites in United States
- Volunteers
- 360 people
- Sponsor
- Arsenal Medical, Inc.
Chronic Subdural Hematomas, Cerebral Compression Due to Injury
Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)
Chronic Subdural Hematomas (cSHD) are common, and due to cerebral compression, often result in neurological impairment and reduced consciousness. Surgery is typically performed once neurological symptoms develop.
- Trial name
- STORMM (NCT06163547)
- Testing
- MMA embolization
- Where
- 2 sites in Switzerland
- Volunteers
- 180 people
- Sponsor
- University Hospital, Geneva
Chronic Subdural Hematoma
Postoperative Balloninflation After Evacuation of cSDH
In this prospective, randomized, multicenter trial shall patients with chronic subdural hematoma (cSDH) recruited, who were surgically treated.
- Trial name
- BANISH (NCT04060186)
- Testing
- Balloninflation
- Where
- Germany
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Johann Wolfgang Goethe University Hospital
Conscious Sedation
Magnesium Sulphate Versus Fentanyl for Conscious Sedation in CSDH
The investigators hypothesize that magnesium sulphate owing to its analgesic and sedative properties is not inferior to fentanyl in providing conscious sedation as adjuvants to propofol and local injection of lidocaine in…
- Trial name
- CSDH (NCT03548493)
- Testing
- Magnesium sulphate, Fentanyl, Propofol
- Where
- Egypt
- Volunteers
- 34 people
- Sponsor
- Kasr El Aini Hospital
Chronic Subdural Hematoma
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…
- Trial name
- RATATA (NCT07245264)
- Testing
- Tranexamic Acid (Cyklokapron)
- Where
- India
- Volunteers
- 274 people
- Sponsor
- St. Olavs Hospital
Chronic Subdural Hematoma, Recurrence
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
- Trial name
- NCT06401772
- Testing
- Intracranial Hypotension Targeted(IHT) Body Posture
- Where
- China
- Volunteers
- 830 people
- Sponsor
- Huashan Hospital
Chronic Subdural Hematoma, Hemorrhage Brain
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
- Trial name
- SCIENTIA (NCT07324551)
- Testing
- Matched pair Aristotle 14 guidewire and Plato 17 microcatheter, Surgeon combination preference
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Ohio State University
Chronic Subdural Hematoma
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.
- Trial name
- CHESS (NCT06347796)
- Testing
- Conventional Surgery, Middle Meningeal Artery Embolization (MMAE)
- Where
- 31 sites in United States
- Volunteers
- 520 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Chronic Subdural Hematoma, Anesthesia
Nerve Block Anesthesia Combined With Sedative Anesthesia Versus General Anesthesia in Surgery for CSDH
A prospective, multicenter, randomized controlled trial is designed to evaluate the safety of nerve block anesthesia combined with sedative anesthesia versus general anesthesia during burr hole craniostomy with drainage for…
- Trial name
- NCT05888389
- Testing
- Cranial Nerve Block Anesthesia Combined With Sedative Anesthesia, General Anesthesia
- Where
- China
- Volunteers
- 190 people
- Sponsor
- Beijing Tiantan Hospital
Chronic Subdural Hematoma
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…
- Trial name
- SAFER-MMAE (NCT07729098)
- Testing
- Bevacizumab (intra-arterial)
- Volunteers
- 18 people
- Sponsor
- Dheeraj Gandhi