Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-23

Study Completion Date

2018-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this feasibility study is to demonstrate the safety and feasibility of using an investigational extracorporeal system and catheter to filter hemorrhagic cerebrospinal fluid (CSF) post subarachnoid hemorrhage (SAH) treatment, and reintroduce the CSF via the same catheter.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension

NCT03607825

Subarachnoid Hemorrhage

COMPLETED NA

Cervical Spinal Cord Stimulation in Cerebral Vasospasm

NCT02426827

Cerebral Vasospasm

WITHDRAWN NA

Cervical Sympathetic Block in Patients With Cerebral Vasospasm

NCT05230134

Anesthesia, Local Cerebral Vasospasm Subarachnoid Hemorrhage, Aneurysmal

ENROLLING_BY_INVITATION NA

Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage

NCT07246629

Subarachnoid Hemorrhage

NOT_YET_RECRUITING PHASE4

Ventriculostomy in Subarachnoid Hemorrhage (SAH): Intracranial Pressure (ICP) Open or Not?

NCT01169454

Subarachnoid Hemorrhage

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Subarachnoid Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group

Group Type EXPERIMENTAL

Spinal catheter insertion with extracorporeal filtration of CSF

Intervention Type DEVICE

Extracorporeal filtration of CSF

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spinal catheter insertion with extracorporeal filtration of CSF

Extracorporeal filtration of CSF

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age: 18 years or older
* Informed consent by the patient or his/her legally authorized representative
* Modified Fisher Grade 2, 3, or 4
* Hunt \& Hess I-III
* First aneurysmal SAH that has been confirmed by Angio, CTA or MRA
* Patient is ≤ 48 hours post bleeding event
* World Federation of Neurosurgeons (WFNS) Grades I-IV and those Grade V patients who improve to Grade IV or less after ventriculostomy.

Exclusion Criteria

* Patients with a SAH due to mycotic aneurysm or AV malformation
* Patients who present with an acute MI or unstable angina
* Patients with uncontrolled diabetes
* Patients who present with a creatinine \> 2.0mg/dl
* Imaging demonstrates supratentorial mass lesions greater than 50 cc
* Imaging demonstrates more than 5 mm of mid-line-shift associated with infarction and or edema
* Effacement of the basilar cisterns (suprasellar, ambient, chiasmatic and quadrageminal)
* Vasospasm on admission as defined by angiographic evidence
* Patients with a coagulopathy that cannot be reversed per the professional discretion of the investigator
* Thrombocytopenia def. platelet count \< 100,000
* Patients on low molecular weight heparin e.g., Lovenox
* Patients on Clopidogrel bisulfate (Plavix) or other chronic platelet inhibitors
* Patients with a documented history of cirrhosis
* Patients who will be managed with supportive care rather than intervention
* Obstructive hydrocephalus i.e., non-communicating
* Pregnancy
* History of posterior fusion hardware that would interfere with placement of the catheter
* Pre-existing Lumbar Drain
* Local skin infections or eruptions over the puncture site
* Signs of systemic infection/sepsis or pneumonia
* Lumbar puncture within 6 hours
* Concurrent participation in another study which is not observational or retrospective in nature without prior approval from the Sponsor

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No