Clinical trials: Chronic Subdural Hematomas
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.
Hematoma, Subdural Hematoma
Patient Registry for Patients With Chronic Subdural Hematoma
All admitted patients diagnosed with unilateral or bilateral chronic subdural hematoma are included into this registry after consent.
- Conditions
- Hematoma, Subdural Hematoma, Chronic
- Trial name
- CSDH-R (NCT04170582)
- Where
- Germany
- Volunteers
- 250 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Chronic Subdural Hematoma
The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma
The study will be a multicenter randomised controlled trial of the use of irrigation fluid of body temperature versus irrigation fluid of room temperature during burr hole evacuation of chronic subdural hematoma.
- Trial name
- SIC! (NCT02757235)
- Testing
- Irrigation fluid of body temperature, Irrigation fluid of room temperature
- Where
- 3 sites in Sweden
- Volunteers
- 588 people
- Sponsor
- Sahlgrenska University Hospital
Chronic Subdural Hematoma
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).
- Trial name
- CHAI (NCT06510582)
- Testing
- Bevacizumab 2 mg/kg, Bevacizumab 4 mg/kg
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- The Cooper Health System
Chronic Subdural Hematomas
Treatment of Chronic Subdural Hematoma by Corticosteroids
Chronic subdural hematomas are a frequent neurosurgical pathology in the elderly. Gold standard is surgical evacuation of these hematomas.
- Trial name
- SUCRE (NCT02650609)
- Testing
- Methylprednisolone
- Where
- 17 sites in France
- Volunteers
- 202 people
- Sponsor
- Rennes University Hospital
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, Subdural Hematoma
Prospective Study on the Use of Middle Meningeal Artery Embolization for Chronic Subdural Haematoma
Subdural haematoma is a common neurosurgical condition that results in different levels of neurological deficits in patients. It can be further classified into acute and chronic, which have different pathophysiology.
- Trial name
- NCT04500795
- Testing
- Middle meningeal artery embolization
- Where
- China
- Sponsor
- Chinese University of Hong Kong
Chronic Subdural Hematoma
Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)
Puerto Rico Embolization of the Middle Meningeal Artery (PREMMA) trial is a multi-center, parallel, prospective, superiority, randomized controlled trial with concealed allocation comparing reoperation rates and neurological…
- Trial name
- PREMMA (NCT06466733)
- Testing
- Embolization of the middle meningeal artery, Surgical Evacuation via burr hole or craniotomy
- Volunteers
- 658 people
- Sponsor
- Juan M. Ramos Acevedo
Chronic Subdural Hematoma
Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)
A prospective, multicenter, case control trial is designed to compare difference in dietary and nutritional factors in patients with and without chronic subdural hematoma.
- Trial name
- DISH (NCT05599217)
- Testing
- Dietary and nutritional questionnaire, Neurological function, cognitive function, and life quality assessment, Peripheral blood test
- Where
- 4 sites in China
- Volunteers
- 420 people, healthy volunteers welcome
- Sponsor
- Beijing Tiantan Hospital
Chronic Subdural Hematoma
Endovascular Embolization of Chronic Subdural Hematomas After Surgery
Chronic subdural hematomas (CSH) are one of the most frequent pathologies in emergency neurosurgical practice. Standard therapy for symptomatic CSH is surgical drainage.
- Trial name
- ENCLOSURE (NCT05220826)
- Testing
- Post surgical embolization of middle meningeal artery with liquid embolic agents (ethylene vinyl alcohol copolymers as Onix, Squid, Phil or Libro)
- Where
- Spain
- Volunteers
- 280 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Subdural Hematoma, Atrial Fibrillation
Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma
Subdural hematoma (SDH) is a common disorder that typically results from head trauma and has increased in prevalence in recent decades.
- Trial name
- ATTAACH (NCT05472766)
- Testing
- Direct Acting Oral Anticoagulant starting at Day 30, Direct Acting Oral Anticoagulant starting at Day 90
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- Sunnybrook Health Sciences Centre
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 Hematoma
Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2
Chronic subdural hematoma (CSDH), a common disease after minor head trauma, is characterized by blood collection in the subdural space, which can result in severe neurological impairment.
- Trial name
- TRACE-2 (NCT04898712)
- Testing
- Tranexamic Acid 500 MG
- Where
- Canada
- Volunteers
- 90 people
- Sponsor
- Unity Health Toronto
Chronic Subdural Hematoma
Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
The SWEMMA trial is an open, national, multi-center, prospective, randomized (1:1), superiority trial designed to assess impact on reoperation rates for chronic subdural hematoma with a head-to-head comparison of embolization of…
- Trial name
- SWEMMA (NCT05267184)
- Testing
- Endovascular treatment of the middle meningeal artery, Standard neurosurgical hematoma evacuation
- Where
- 4 sites in Sweden
- Volunteers
- 288 people
- Sponsor
- Region Skane
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.
- Trial name
- NCT07688473
- Testing
- Chronic Subdural Hematoma Evacuation
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Sohag University
Subdural Hematoma, Subdural Hematoma, Chronic
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH)
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, Epilepsy; Seizure
Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas
Some patients with chronic subdural hematomas and transient neurological symptoms do not respond to standard antiepileptic drugs.
- Conditions
- Chronic Subdural Hematoma, Epilepsy; Seizure, Cortical Depression; Cortical Depolarization, Nonepileptic, Stereotypical and Intermittent Symptoms
- Trial name
- GENESIS (NCT04759196)
- Testing
- Topamax, Levetiracetam
- Where
- Canada
- Volunteers
- 56 people
- Sponsor
- Université de Sherbrooke
Hematoma, Subdural, Chronic, Brain Diseases
The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma
Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach might increase the likelihood of resolution and might prevent reaccumulation of Chronic Subdural Hematoma (CSDH).
- Conditions
- Hematoma, Subdural, Chronic, Brain Diseases, Central Nervous System Diseases, Wounds and Injuries
- Trial name
- OTEMACS (NCT04742920)
- Testing
- Middle Meningeal Artery Embolization, Standard Management
- Where
- 6 sites in France
- Volunteers
- 247 people
- Sponsor
- University Hospital, Montpellier