Clinical trials: Intracranial Hemorrhage, Traumatic
Traumatic Brain Injury
Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure…
- Trial name
- NCT05951777
- Testing
- Autologous HB-adMSCs, Normal Saline
- Where
- 2 sites in United States
- Volunteers
- 51 people
- Sponsor
- Hope Biosciences LLC
Traumatic Brain Hemorrhage
SAFETY: Stabilization Points to Third Hospital Line Assessment oF the Impact of the usE of Infrascanner Model 2500 to Provide Decision Support for Diagnosis/Screening of Traumatic Brain InjurY in Ukraine
The Infrascanner model 2500 is a handheld, noninvasive device that is FDA-cleared to detect traumatic intracranial hematomas. FDA clearance K200203 was issued in 2020, K211617 added pediatric age group to the IFU in 2022, and…
- Trial name
- SAFETY (NCT07014748)
- Testing
- Handheld brain hematoma detector
- Where
- 4 sites in United States, Ukraine
- Volunteers
- 600 people
- Sponsor
- InfraScan, Inc.
Traumatic Subdural Hematoma
Factors Influencing Readmission Rates of Acute Traumatic Subdural Hematoma in the Elderly
Acute traumatic subdural hematomas (TSDH) readmission rate is high (27.8%) with an increase in morbidity and cost for the elderly.
- Trial name
- NCT03878043
- Testing
- Follow-up Care
- Where
- United States
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- Tarik Wasfie, MD
Traumatic Brain Injury, Intracranial Hemorrhages
Usability Study of CEREBO® - A Novel Non-invasive Intracranial Bleed Detector
Traumatic Brain Injury (TBI) is the leading cause of death and disability across the globe. Time from injury to treatment is the most critical factor that determines the patient's recovery.
- Trial name
- NCT05340114
- Testing
- CEREBO®
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Bioscan Research Pvt. Ltd.
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
Brain Edema, TBI (Traumatic Brain Injury)
Dynamic Decompressive Craniotomy
Prospective observational study on patients undergoing decompressive craniotomy
- Conditions
- Brain Edema, TBI (Traumatic Brain Injury), Stroke, Acute, Cerebral Hemorrhage
- Trial name
- NCT05051488
- Testing
- Dynamic craniotomy
- Volunteers
- 20 people
- Sponsor
- Rohit Khanna, MD
Head Injury
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial…
- Trial name
- NCT01824589
- Testing
- -7 cm H2O ITPR, -12cm H2O ITPR
- Volunteers
- 1 people
- Sponsor
- Advanced Circulatory Systems
Traumatic Subarachnoid Haemorrhage
Neurological Outcome in Patients of Traumatic Subarachnoid Haemorrhage
Traumatic brain injury is common cause of morbidity and mortality worldwide. Incidence and pattern of traumatic brain injury varies in developed and developing countries.
- Trial name
- NCT02073890
- Volunteers
- 117 people
- Sponsor
- Macmillan Research Group UK
Chronic Subdural Hematoma
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…
- Trial name
- MEMBRANE (NCT04816591)
- Testing
- Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System, Standard of Care Surgery, Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System
- Where
- 33 sites in United States, China
- Volunteers
- 376 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
Intracranial Hemorrhages, Traumatic Brain Injury
Evaluate the SENSE Device's Ability to Monitor and Detect Intracranial Hemorrhage
This study is a two-stage, pivotal, prospective, non-randomized, multi-center, within patient comparison of the SENSE device and the standard diagnostic test, head CT scan in patients with a diagnosis of primary spontaneous ICH…
- Trial name
- NCT04642443
- Testing
- SENSE Device
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- Sense Diagnostics, LLC
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
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.
Brain Injuries, Traumatic
Biomarkers of Traumatic Brain Injury With Tbit System
A prospective, multi-center, non-randomized, pivotal study to assess the safety and efficacy of the Tbit™ System to aid in patient evaluation, suspected of traumatic brain injury, as adjunct companion test to radiologic standard…
- Trial name
- NCT04107662
- Testing
- Tbit system
- Volunteers
- 740 people
- Sponsor
- BioDirection Inc
Cerebral Hemorrhage, Head Injury
Biomarkers Correlation With Volemia
The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro Endothelin) changes at Day 2, Day 5 and Day 7…
- Conditions
- Cerebral Hemorrhage, Head Injury, Non Traumatic Post Surgery, Poly Trauma Patients Without Heart Failure
- Trial name
- ENVOL (NCT01858675)
- Testing
- Biomarkers, red blood cells and plasma assessment
- Where
- France
- Volunteers
- 66 people
- Sponsor
- ThermoFisher Scientific Brahms Biomarkers France
Subdural Hematoma
Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System 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 Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma…
- Trial name
- EMBOLISE (NCT04402632)
- Testing
- Surgical Management, Onyx™ Liquid Embolic System (LES) Embolization, Observation Only
- Where
- 49 sites in United States
- Volunteers
- 600 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
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.
Intracranial Pressure, Intracranial Pressure Changes
CoMind Early Feasibility Study
The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around…
- Conditions
- Intracranial Pressure, Intracranial Pressure Changes, Traumatic Brain Injury, Intracerebral Hemorrhage
- Trial name
- CoMind EFS (NCT06368648)
- Where
- 17 sites in United States
- Volunteers
- 581 people
- Sponsor
- CoMind Technologies Limited
Traumatic Brain Injury
A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy
This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury…
- Trial name
- NCT04063215
- Testing
- HB-adMSCs
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Hope Biosciences LLC
Neurologic Disorders, Nervous System Diseases
Neurologic Stem Cell Treatment Study
This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in order to determine if such a treatment will…
- Conditions
- Neurologic Disorders, Nervous System Diseases, Neurodegenerative Diseases, Neurological Disorders
- Trial name
- NEST (NCT02795052)
- Testing
- Intravenous and Intranasal BMSC
- Where
- 3 sites in United States, United Arab Emirates
- Volunteers
- 500 people
- Sponsor
- MD Stem Cells
Subdural Hematoma, Chronic
The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)
STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1) controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for…
- Trial name
- STEM (NCT04410146)
- Testing
- SQUID Embolization, SQUID Embolization and Surgical Evacuation, Surgical Evacuation
- Where
- 32 sites in United States, France and 2 more
- Volunteers
- 319 people
- Sponsor
- Balt USA