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Cerebrospinal Fluid (CSF) Drainage Study
High Volume Cerebrospinal Fluid Diversion in the Management of Aneurysmal Subarachnoid Hemorrhage: A Pilot Study
When patients suffer a subarachnoid hemorrhage (bleeding around the brain), they often develop hydrocephalus. This is an enlargement of the fluid-filled spaces (ventricles) in the brain. Standard-of-care treatment includes placing an external ventricular drain (EVD) to drain off fluid. Eventually the EVD is weaned with the goal of removing it. Occasionally a patient does not tolerate this and a permanent surgery needs to be done to internalize a shunt.
Though this is done commonly and routinely throughout the world, there are no good studies to address how to optimally set the EVD level and how fast to wean it. Most set the EVD to a level of around 15 mmHg. The investigators hypothesize that setting the EVD lower (which will allow higher volume Cerebrospinal Fluid (CSF) drainage through the EVD) will improve perfusion at the level of the microcirculation in the brain, and result in improved neurologic outcomes.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Florida
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Jacksonville, Florida, Verenigde Staten, 32224
- Mayo Clinic in Florida
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic in Rochester
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria
- Age ≥ 18 years
- Diagnosis of acute subarachnoid hemorrhage (SAH), confirmed with noncontrast head CT
- SAH is suspected to be aneurysmal in source
- Clinical management requires placement of EVD within 2 days of suspected time of hemorrhage
Exclusion Criteria
- Age < 18 years
- SAH of traumatic or non-aneurysmal etiology
- Patients treated with lumbar drains
- EVD placement ≥ 3 days after suspected time of hemorrhage
- Known contraindication to induction of relative intracranial hypotension (e.g. acute subdural hematoma)
- Pre-morbid mRS ≥ 3
- EVD that is suboptimally placed by CT obtained after EVD placement (i.e. EVD not in the ventricular system)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: High volume CSF diversion
The EVD will be set to an initial level of 5 mmHg.
The drain will remain in place at a level of ≤ 5 mmHg until at least day 10 after SAH before a weaning trial is attempted.
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CSF drainage
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Actieve vergelijker: Conventional CSF diversion
The EVD will be set to a level of 15 mmHg for as long as needed for the treatment of hydrocephalus, and subsequently weaned at the discretion of the treating physician.
Lowering the level of the EVD can be considered by the treating physician if sustained intracranial hypertension occurs
|
CSF drainage
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Modified Rankin Scale
Tijdsspanne: 90-days
|
The primary outcome is clinical outcome at 90 days.
A favorable outcome is defined as a score of 1 or 2 on the modified Rankin Score (mRS) and poor outcome defined as a mRS of 3-6.
This assessment will be made by a clinician who was blinded to the patient's CSF diversion treatment arm.
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90-days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Infarction
Tijdsspanne: 90-days
|
Presence of radiologic infarction
|
90-days
|
Vasospasm
Tijdsspanne: 90-days
|
Evidence of vasospams based upon TCD and/or angiography
|
90-days
|
Shunt placement
Tijdsspanne: 90-days
|
Rate of shunt placement
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90-days
|
Ventriculitis
Tijdsspanne: 90-days
|
Rate of ventriculitis
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90-days
|
Modified Rankin Scale
Tijdsspanne: Hospital discharge (average 3 weeks)
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Modified rankin Scale upon discharge from the hospital
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Hospital discharge (average 3 weeks)
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MMSE
Tijdsspanne: 90-days
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Cognitive status evaluated using the MMSE
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90-days
|
Length of ICU stay
Tijdsspanne: Average 3 weeks
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Evalute the average length of ICU stay for this patient population.
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Average 3 weeks
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Giuseppe Lanzino, MD, Mayo Clinic
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 11-002713
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