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Neurosurgery vs. Shunting for Intracranial Hypertension (OPEN-UP Trial)
N/A
Recruiting
Led By Felipe C Albuquerque, MD
Research Sponsored by St. Joseph's Hospital and Medical Center, Phoenix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study entry, six months and one year
Awards & highlights
OPEN-UP Trial Summary
This trial will compare dural venous sinus stenting to the current standard treatment (CSF shunting) for pseudotumor cerebri (IIH) patients with moderate vision loss and stenosis of the dural venous sinuses.
Who is the study for?
This trial is for women over 18 with Pseudotumor Cerebri who can't get pregnant, have tried and failed non-surgical treatments, and suffer from moderate to severe vision loss. They must not have other major health issues that could interfere with the study or be on certain medications.Check my eligibility
What is being tested?
The trial compares two procedures for treating Pseudotumor Cerebri: dural venous sinus stenting (placing a stent in brain veins) versus cerebrospinal fluid shunting (diverting fluid to relieve pressure). It aims to see which is more effective at improving symptoms like headaches and vision loss.See study design
What are the potential side effects?
Possible side effects include risks associated with general anesthesia, complications from placing a stent such as bleeding or stroke, infection risk from surgery, and potential failure of the procedure requiring additional interventions.
OPEN-UP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Perimetric mean deviation (PMD) at six months
Secondary outcome measures
Pharmaceutical Preparations
Papilledema
Quality of life
+1 moreOPEN-UP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dural Venous Sinus StentingExperimental Treatment1 Intervention
Pt. will undergo pre-treatment with aspirin and clopidogrel. Transfemoral venous access will be obtained (pt. heparinized).Guide catheter will be placed in jugular bulb ipsilateral to dural venous sinus stenosis. Stent will be deployed across stenotic segment. Balloon angioplasty will not be performed unless initial stenosis is not easily traversed with stent. No pressure measurements will be taken during stent placement. Patients will undergo serial physical/neuro exams for 24 hours post-procedure. Daily dual anti-platelet treatment will continue for 6 months after initial procedure, after which clopidogrel will be discontinued and aspirin 81mg daily will be prescribed indefinitely. If significant bilateral venous sinus stenosis is present, stenosis with more severe pressure gradient will be stented. In pt. with bilateral venous sinus stenosis with equivalent pressure gradients, side will be at surgeon's discretion.
Group II: Cerebrospinal Fluid ShuntingActive Control1 Intervention
Choice of shunt procedure (ventriculoperitoneal, ventriculoatrial, or lumboperitoneal), catheter laterality, brand and shunt equipment (including shunt catheters and valves), valve settings of programmable shunt valves (when applicable), intrathecal antibiotic administration and the use of stereotactic navigation will be at the discretion of neurosurgeon. Shunt procedures will be performed per the standard of care, under general anesthesia. An optional surgical procedure guidance document will be provided for other sites. Patients will undergo serial physical and neurological examinations for 24 hours post-procedure prior to discharge.
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Who is running the clinical trial?
Barrow Neurological InstituteOTHER
24 Previous Clinical Trials
6,983 Total Patients Enrolled
St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
63 Previous Clinical Trials
14,625 Total Patients Enrolled
Felipe C Albuquerque, MDPrincipal InvestigatorBarrow Neurosurgical Associates
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have other existing conditions that could cause permanent vision loss in the eye being studied, and do not meet the eligible eye criteria for a condition called IIH in the other eye.You have a condition that makes your blood more likely to form clots.Your spinal fluid test shows high protein levels, low glucose levels, or an elevated cell count, unless it's due to a recent spinal tap.You have had a surgery to drain fluid from your brain or to relieve pressure around your optic nerve.You have had an allergic reaction to iodine contrast used in medical imaging.Your kidney function is significantly impaired, as shown by a high level of creatinine in your blood.You have a problem with blood vessels in your brain or another mass in your head.You can't reliably and accurately complete visual field exams, with too many mistakes or trouble focusing during the test.You have had or currently have an eye disease like glaucoma or retinopathy.Your vision in the study eye is worse than 20/200, and the other eye doesn't meet the vision criteria either.You have a medical condition that increases the risk of eye problems like retinopathy, such as type I diabetes.You have taken certain medications or substances that could increase pressure inside your head in the past 2 months.You have tried other treatments for your condition and they didn't work, you couldn't tolerate the medication, or the doctor doesn't think those treatments are right for you.You have significant vision loss in one eye, but it's not the worst level of loss.A special test shows high pressure in the veins in your head.You have a severe and unmanageable headache condition like chronic migraine or medication overuse headache.You cannot take aspirin, clopidogrel, or other blood-thinning medications for medical reasons.Your cerebrospinal fluid pressure is less than 20 cm H2O during a lumbar puncture.You cannot have general anesthesia for medical reasons.You are 18 years old or older.You have been diagnosed with Idiopathic Intracranial Hypertension based on specific criteria.You have a significant loss of vision in your worst eye, but it's not the most severe.You must be at least 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Dural Venous Sinus Stenting
- Group 2: Cerebrospinal Fluid Shunting
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers able to participate in this experiment right now?
"Indeed, the records on clinicaltrials.gov support that this medical trial is actively accepting participants. It was initially posted in June 3rd 2020 and last revised on September 20th 2021; it needs 80 individuals to be recruited from 2 different medical centres."
Answered by AI
What is the capacity for participants in this investigation?
"Indeed, the information found on clinicaltrials.gov reveals that recruitment for this study is ongoing. It was first posted on June 3rd 2020 and has undergone its latest update as of September 20th 2021. The trial requires 80 participants to be recruited from 2 medical sites."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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