Clinical trials: Craniectomy
Cerebral Hemorrhage
Decompressive Hemicraniectomy in Intracerebral Hemorrhage
Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30 per 100'000 population, accounting for 2…
- Trial name
- SWITCH (NCT02258919)
- Testing
- Decompressive craniectomy (DC) and best medical treatment, Best medical treatment
- Where
- 32 sites in Austria, Belgium and 6 more
- Volunteers
- 201 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Middle Cerebral Artery Occlusion With Cerebral Infarction
The AGAINST Protocol: Augmentative Craniotomy in Stroke
Malignant Middle Cerebral Artery (MCA) infarction is a term used for the severe clinical and neurological hemispheric syndrome caused by ischemic occlusion of the proximal tract of MCA and it is observed in near the 10% of all…
- Trial name
- AGAINST (NCT05860855)
- Testing
- Augmentative craniotomy, Decompressive craniotomy
- Volunteers
- 70 people
- Sponsor
- University of Roma La Sapienza
Traumatic Brain Injury, Subdural Hematoma
Hypernatremia for the Prevention and Treatment of Cerebral Edema in Traumatic Brain Injury
Cerebral edema is seen heterogenous group of neurological disease states that mainly fall under the categories of metabolic, infectious, neoplasia, cerebrovascular, and traumatic brain injury disease states.
- Conditions
- Traumatic Brain Injury, Subdural Hematoma, Cerebral Contusion, Head Injury
- Trial name
- NCT01605357
- Testing
- Induced, sustained hypernatremia using hypertonic saline, Standard of care (hypertonic saline and mannitol; serum sodium)
- Sponsor
- Massachusetts General Hospital
Stroke, Acute
aICP Measurement in Patients With Cerebral Artery Infarction / aICP MCA Infarction
Space-occupying, malignant middle cerebral artery (M-MCA) infarctions are still one of the most devastating forms of ischemic stroke, with a mortality of up to 80% in untreated patients.
- Trial name
- aICPStroke (NCT03641963)
- Testing
- Vittamed 205 Non-invasive intracranial pressure (ICP) meter
- Where
- Switzerland
- Volunteers
- 48 people
- Sponsor
- Kantonsspital Aarau
Posterior Fossa Lesion
Comparison of Surgical Outcomes of Craniotomy and Craniectomy in Posterior Fossa Lesions
The purpose of this randomized controlled trial is to compare the surgical outcomes of craniotomy and craniectomy among patients with posterior fossa lesions.
- Trial name
- NCT06831695
- Testing
- Craniotomy, Craniectomy
- Volunteers
- 80 people
- Sponsor
- University of Health Sciences Lahore
Supratentorial Brain Tumor Surgery
FASt Track in Elective Neurosurgery: the Role of Low Propofol Bis-NOL Guided General Anaesthesia for Full, Early and Safe Awakening
To evaluate the effect of intraoperative sedation dosage on awakening and recovery of consciousness after elective neurosurgical surgery.
- Trial name
- FasTrack (NCT06844838)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Severe Traumatic Brain Injury
Cisternostomy Vs Decompressive Craniectomy for Severe Traumatic Brain Injury
The objective of this clinical study is to compare the outcomes of two neurosurgical interventions, Cisternostomy and Decompressive Craniectomy (DC), for the management of severe Traumatic Brain Injury (TBI), assessed using the…
- Trial name
- NCT06363474
- Testing
- Decompressive Craniectomy, Cisternostomy
- Volunteers
- 190 people
- Sponsor
- University of Health Sciences Lahore
Hypertension Intracranial
Decompressive Craniectomy for Severe Traumatic Brain Injury in Children With Refractory Intracranial Hypertension
Severe traumatic brain injury (TBI) is the leading cause of mortality and severe disability in the pediatric population. The prognosis of these patients depends on the severity of the initial lesions but also on the effectiveness…
- Trial name
- RANDECPED (NCT03766087)
- Testing
- decompressive craniectomy
- Where
- France
- Sponsor
- Fondation Lenval
Traumatic Brain Injury, Middle Cerebral Artery Stroke
Intracranial Pressure After Decompressive Craniectomy
Observational study to investigate the natural course of intracranial pressure (ICP) after decompressive craniectomy (DC) using long-term telemetric ICP monitoring.
- Conditions
- Traumatic Brain Injury, Middle Cerebral Artery Stroke, Intracranial Hemorrhages, Intracranial Hypertension
- Trial name
- NCT03364634
- Testing
- Intracranial pressure monitoring
- Volunteers
- 17 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Craniectomy, Trephined Syndrome
External Post-Operative Skull Prosthesis to Prevent Sunken Flap Syndrome in Craniectomy Patients
Patients that undergo decompressive craniectomy are at risk of delayed changes in brain function known as "Sunken Flap Syndrome" or "Syndrome of the Trephined." The goal of this clinical trial is to see if placing a prosthetic…
- Conditions
- Craniectomy, Trephined Syndrome, Traumatic Brain Injury (TBI) Patients, Ischemic Stroke
- Trial name
- ExO-Skull (NCT06899711)
- Testing
- External Cranial Prosthesis
- Where
- 2 sites in United States
- Volunteers
- 72 people
- Sponsor
- Johns Hopkins University
Traumatic Brain Injuries
Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome
Intractable high intracranial pressures (ICP) are associated with poor functional outcomes and mortality, so the SCALPEL trials aims to evaluate the effect of decompressive craniectomy against decompressive laparotomy to lower…
- Trial name
- SCALPEL (NCT05115929)
- Testing
- Decompressive Laparotomy, Decompressive Craniectomy
- Where
- 4 sites in France, Germany
- Volunteers
- 100 people
- Sponsor
- Technical University of Munich
Decompressive Craniectomy, Brain Injuries
Good Prognosis Factors After Decompressive Craniectomy : a Ten-year Retrospective Study
Decompressive craniectomy is a treatment of refractory intracranial hypertension after various etiologies : malignant ischemic stroke, traumatic brain injury, intraparenchymal hemorrhage, aneurysmal subarachnoid hemorrhage…
- Conditions
- Decompressive Craniectomy, Brain Injuries, Treatment Outcome
- Trial name
- NCT04682951
- Testing
- Decompressive Craniectomy
- Where
- France
- Volunteers
- 544 people
- Sponsor
- Central Hospital, Nancy, France
Brain Injury, Neuropsychological Deficits
Cognitive Functions in Severe Acquired Brain Injury After Cranioplasty
Cranioplasty is the main reconstructive neurosurgical procedure, performed in approximately 80% of patients who have previously undergone demolitive surgeries in an emergency setting, particularly in the case of decompressive…
- Conditions
- Brain Injury, Neuropsychological Deficits, Cranioplasty, Cognitive Deficit Following Brain Lesions
- Trial name
- NeC (NCT06895109)
- Testing
- improvement of cognitive functions and psychological aspects
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Scarring
Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring
The purpose of this study is to evaluate the effectiveness of dHACM in reducing scar tissue formation in craniectomy patients as well as facilitating reoperation and repair.
- Trial name
- NCT02033824
- Testing
- dHACM, Craniectomy
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- MiMedx Group, Inc.
Ischemic Stroke, Acute, Malignant Cerebral Edema
Expansion-floating Craniotomy for the Treatment of Malignant Cerebral Edema Caused by Acute Ischemic Stroke
This clinical study investigates Expansion-floating Craniotomy (EC), a novel surgical technique for treating life-threatening malignant cerebral edema following large hemispheric infarction (commonly known as massive stroke).
- Trial name
- ECAIS (NCT07195786)
- Testing
- Expansion-floating Craniotomy, decompressive craniectomy, drug conservative therapeutic
- Volunteers
- 356 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Cerebellar Stroke
Decompressive Craniectomy in Patients With Cerebellar Infarction
The investigators aimed to evaluate the outcome in participants up to 80 years of age with space-occupying cerebellar infarction treated with suboccipital decompressive craniectomy (SDC) compared to medical therapy alone.
- Trial name
- DEMCI (NCT05670249)
- Testing
- suboccipital decompressive craniectomy
- Volunteers
- 72 people
- Sponsor
- Ege University
Skull Defect
Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）
The objective of this trial is to scientifically evaluate the efficacy of PEEK cranioplasty and titanium cranioplasty. The primary objective is to compare the rate of implant failure (defined as infection, implant exposure and…
- Trial name
- NCT05416684
- Where
- China
- Volunteers
- 358 people
- Sponsor
- RenJi Hospital
Tumor, Cerebral Ventricle, Tumor, Cerebellar
Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®
Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.
- Conditions
- Tumor, Cerebral Ventricle, Tumor, Cerebellar, Aneurysm Cerebral, Trauma, Brain
- Trial name
- LYOPLACE (NCT05441618)
- Testing
- Lyoplant®
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Aesculap AG
Aneurysmal Subarachnoid Hemorrhage
Decompressive Craniectomy After Aneurysmal Subarachnoid Hemorrhage (DECIDE-SAH)
DECIDE-SAH is an international, multicenter, retrospective, observational, non-interventional secondary-use cohort study of adults with aneurysmal subarachnoid hemorrhage (aSAH).
- Trial name
- DECIDE-SAH (NCT07872774)
- Testing
- Decompressive craniectomy
- Where
- Germany
- Volunteers
- 10,000 people
- Sponsor
- University Hospital, Essen
Craniectomy, Quality of Life
Long-term Outcomes in Terms of Disability and Quality of Life for Patients Undergoing Posterior Cranial Fossa Craniectomy in the Context of Compressive Cerebellar Hematoma
Posterior cranial fossa craniectomy has been shown to improve patient survival. The level of autonomy, disability and quality of life of survivors has been little studied and still underresearched,.
- Conditions
- Craniectomy, Quality of Life, Cerebellar Haematoma, Handicaps Physical
- Trial name
- CHANCE (NCT04672785)
- Testing
- SF36 questionary
- Where
- France
- Volunteers
- 26 people
- Sponsor
- University Hospital, Grenoble