Clinical trials: Leak, Cerebrospinal Fluid
Postdural Puncture Headache, Post-Lumbar Puncture Headache
Incidence of Headache Following an Unintentional Dural Puncture
The purpose of this study is to evaluate the use of intrathecal morphine administration following an unintentional dural puncture, to decrease the incidence of post dural puncture headaches (PDPH) in obstetric patients.
- Conditions
- Postdural Puncture Headache, Post-Lumbar Puncture Headache, Cerebrospinal Fluid Leaks
- Trial name
- NCT01977898
- Testing
- Morphine, Saline
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Cerebrospinal Fluid Leak
Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a…
- Trial name
- ENCASE-II (NCT04086550)
- Testing
- LIQOSEAL, DuraSeal, Adherus
- Where
- 17 sites in United States, Austria and 5 more
- Volunteers
- 228 people
- Sponsor
- Polyganics BV
CSF Leak
Evaluation of Internal Nasal Splint-Supported Free Graft Versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
The study aims to compare the feasibility and effectiveness of using an internal nasal splint- supported free graft versus a nasoseptal flap alone for endoscopic repair of bilateral CSF leaks.
- Trial name
- CSF (NCT07368348)
- Testing
- Internal Nasal Splint-Supported Free Graft, Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Kafrelsheikh University
Subarachnoid Haemorrhagic Stroke
Investigation of the Role of Inflammatory Markers in the Early Detection of Cerebral Vasospasm, Delayed Cerebral Ischemia, and Meningitis Associated With External Cerebrospinal Fluid Drainage After Non-Traumatic Subarachnoid Hemorrhage - A Prospective Case-Control Study
Background Non-traumatic subarachnoid haemorrhage (SAH) is frequently complicated by delayed cerebral ischaemia (DCI) and by ventriculitis/meningitis when external CSF drains are used; bedside TCCD has limited accuracy for…
- Trial name
- NCT07129603
- Where
- Hungary
- Volunteers
- 100 people
- Sponsor
- Tamas Vegh, MD
Cerebrospinal Fluid Leak
The Efficacy and Safety of a Latest Dural Substitute
This prospective, multi-center, randomized, parallel-controlled clinical trial was designed to evaluate the efficacy and safety of Lyoplant Onlay in repairing cerebral dura mater. DURAFORM was regarded as the control group.
- Trial name
- ESLO (NCT04490629)
- Testing
- Lyoplant Onlay, DURAFORM
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Spinal Anesthesia, Intracranial Pressure Change
Effect of Spinal Needle Type on Optic Nerve Sheath Diameter
The optic nerve sheath is a continuation of the dura mater, extending along the subarachnoid space surrounding the optic nerve. Consequently, changes in intracranial pressure cause an augmentation or contraction in the diameter…
- Conditions
- Spinal Anesthesia, Intracranial Pressure Change, Optic Nerve Sheath Diameter, Orthopedic Surgery
- Trial name
- NCT06497634
- Testing
- 25 PP, 25 Q, 27 Q
- Where
- Turkey (Türkiye)
- Volunteers
- 165 people
- Sponsor
- Bagcilar Training and Research Hospital
Dural Tear, Cerebrospinal Fluid Leak
A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair.
The objective of this study was to evaluate the safety and effectiveness of ArtiFascia® in comparison with commercially available dural substitutes in subjects requiring Dural repair following neurosurgery.
- Trial name
- NEOART (NCT04145544)
- Testing
- Implantation of the ArtiFascia®, Implantation of other commercial suturable dural substitute
- Where
- 9 sites in Belgium, Czechia and 3 more
- Volunteers
- 92 people
- Sponsor
- Nurami Medical Ltd
Hyperprolactinemia, Spontaneous Intracranial Hypotension
Pituitary Function and Spontaneous Intracranial Hypotension
Previous research has identified spontaneous cerebral spinal fluid leakage as a cause for spontaneous intracranial hypotension, leading to positional headache patterns.
- Trial name
- NCT02603549
- Testing
- Pituitary panel will be drawn pre-op and post-op for all patients.
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Cedars-Sinai Medical Center
Cerebrospinal Fluid Leak
Perioperative CSF Leak Management - an Opinion Study
Cerebrospinal fluid (CSF) leak is a rare condition. When it involves the ventral skull base, a surgical closure may be achieved using endoscopic skull base surgery techniques.
- Trial name
- NCT04124523
- Where
- France
- Volunteers
- 153 people
- Sponsor
- University Hospital, Montpellier
Cerebrospinal Fluid Leak
Post-market Assessment of Biodesign Dural Repair Grafts
The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.
- Trial name
- NCT04057157
- Testing
- Biodesign Dural or Duraplasty Repair Grafts
- Where
- 3 sites in United States, Canada and 1 more
- Volunteers
- 128 people
- Sponsor
- Cook Research Incorporated
Chronic Subdural Hematoma
Spinal CSF Leaks in Chronic Subdural Hematoma
Background: Chronic subdural hematoma (cSDH) is a type of intracranial bleeding, predominantly affecting the elderly and males, with an estimated incidence of 8/100.000.
- Trial name
- SPICE (NCT06323434)
- Where
- Germany
- Volunteers
- 220 people
- Sponsor
- University of Freiburg
Sellar Tumor, Endonasal Surgery
Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
Primary objective: To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of cerebrospinal fluid (CSF) rhinorrhea within 1 month…
- Conditions
- Sellar Tumor, Endonasal Surgery, Csf Leakage
- Trial name
- EEEA-AMSBP (NCT07539792)
- Testing
- Absorbable and moldable skull base support plate
- Where
- 8 sites in China
- Volunteers
- 126 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Cerebrospinal Fluid Leaks
A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment
The goal of this randomized controlled trial (RCT) is to compare the efficacy of CT fluoroscopy-guided targeted epidural patching for treatment of imaging-confirmed spinal CSF leaks to that of a simulated procedure without…
- Trial name
- NCT03276975
- Testing
- TISSEEL
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Duke University
Heart Arrest, Out-Of-Hospital, Brain Swelling
The Effect of Lumbar CSF Drainage on the Neurologic Outcome Improvement in OHCA Underwent TTM
Aim: The investigators aim to evaluate the effect of lumbar cerebrospinal fluid (CSF) drainage on neurologic outcome in post-cardiac arrest (CA) patients treated with target temperature management (TTM).
- Trial name
- NCT04328974
- Testing
- lumbar CSF drainage
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Chungnam National University Hospital
CSF Leak
The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery
This project seeks to test whether a cell-seeded collagen hydrogel dressing can reduce CSF leak after skull base surgery. Normally, patients at risk for CSF leak are treated with a commercial collagen matrix called Duragen.
- Trial name
- NCT04503161
- Testing
- Duragen with Collagen Hydrodel and ASCs
- Volunteers
- healthy volunteers welcome
- Sponsor
- Stanford University
Cerebrospinal Fluid Leakage
Study to Evaluate the Effectivity and Safety of BIOSCAFF®H Compared to DuraGen®, in Patients Undergoing Dural Repair
Study in which the presence or absence of symptoms or any health condition is observed and recorded 30 days after a cranial surgery in which the physician places a material or graft, either BIOSCAFF®H or DuraGen®, into the skull…
- Trial name
- NCT06419855
- Testing
- Human collagen matrix graft, Bovine collagen matrix graft
- Where
- 4 sites in Mexico
- Volunteers
- 2 people
- Sponsor
- Top Health S.A.P.I DE C.V.
Brain Tumor Adult, Brain Tumor Benign
Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors
Cerebrospinal fluid is a clear fluid that surrounds and protects the brain. During surgery for brain tumors, neurosurgeons often need to open the covering of the brain (the dura) to reach the tumor.
- Conditions
- Brain Tumor Adult, Brain Tumor Benign, CerebroSpinal Fluid (CSF) Leak, Craniotomy
- Trial name
- CSF-IMR (NCT07411690)
- Where
- Poland
- Volunteers
- 200 people
- Sponsor
- Medical University of Warsaw
Skull Base
Bed Rest Duration and Outcomes in Endoscopic Skull Base Reconstruction
This study is a randomized controlled trial conducted across multiple centers. Due to the anatomical and pathological complexity of endoscopic endonasal skull base surgery, the study scope was restricted to the midline anterior…
- Trial name
- BRO (NCT07465861)
- Testing
- non-bed-rest, 2-day bed-rest, 1-day bed-rest
- Volunteers
- 316 people
- Sponsor
- The Affiliated Hospital of Qingdao University
Brain Ischemia, Intracranial Vasospasm
The Tilburg Vasospasm Study
In a prospective randomized controlled trial, the investigators aim to assess whether external lumbar drainage (ELD) of CSF is safe and reduces delayed cerebral ischemia and its sequelae in patients with an aneurysmal…
- Trial name
- NCT01407614
- Testing
- external lumbar drainage (ELD) of cerebrospinal fluid
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Elisabeth-TweeSteden Ziekenhuis
Cerebrospinal Fluid Drainage Catheter
Evaluation of a Simulation Based Workshop in an Anesthesia Residency Program
The study aim is to determine whether simulation based learning would improve senior anesthesiology residents' patient care performance during the insertion and management of cerebrospinal fluid drainage catheters when compared…
- Trial name
- NCT03545984
- Testing
- Simulation-based learning, interactive problem based learning
- Volunteers
- 48 people
- Sponsor
- The Cleveland Clinic