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Device

Clear Bactiseal 'large' catheter (EVD) for Blockage

N/A

Waitlist Available

Led By Kyle M Fargen, MD

Research Sponsored by Wake Forest University Health Sciences

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 48 hours after placement.

Awards & highlights

Study Summary

This trial will compare the rates of occlusion and need for replacement for small vs. large EVD catheters, to see if there is a difference in risk based on catheter size.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours after placement.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours after placement.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours after placement. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Permanent Catheter Occlusions

Secondary outcome measures

Number of Participants With Catheter Replacements

Number of Participants With Procedure-related Hemorrhages

Number of Participants With Symptomatic Hemorrhages

+1 more

Trial Design

2Treatment groups

Active Control

Group I: Clear Bactiseal 'large' catheter (EVD)Active Control1 Intervention

All EVDs will be placed by neurological surgeons in either the major operating suite or in an ICU setting using a previously published protocol. This protocol includes using a burr hole entry point 1 cm anterior to the coronal suture in the mid-pupillary line, prep and sterile drape, pre-procedural antibiotic administration, and tunneling the catheter to an exit site at least 5 cm from the incision. In general, physicians are instructed to first attempt distal irrigation of the drainage chamber using sterile techniques (rarely effective), followed by gentle aspiration of the proximal system and catheter if distal flushing is not effective. If these do not restore patency, a small volume of sterile saline, 3 ml or less, is flushed proximally into the catheter. Patency is checked by lowering the EVD drainage system and evaluating for spontaneous flow through the EVD.

Group II: Orange Bactiseal 'small' catheter (EVD)Active Control1 Intervention

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,239 Previous Clinical Trials

1,004,150 Total Patients Enrolled

Kyle M Fargen, MDPrincipal InvestigatorAssistant Professor, Surgery Neurosurgery

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to participate in this medical experiment?

"This clinical trial is seeking 120 sufferers of occlusion, who are between the ages 18-85. Criteria for qualification include: being an adult, having a Glasgow Coma Scale (GCS) score greater than 7 and requiring frontal EVD placement due to a diagnosis such as subarachnoid hemorrhage, intraventricular hemorrhage or hypertension; additionally any patient whose attending neurosurgeon determines that frontal EVD placement with planned CSF drainage for 72 hours or more would be beneficial may qualify."

Answered by AI

Is the age criterion of 65 years+ considered when admitting participants to this experiment?

"This trial is allowing for volunteers that are 18 or older, but not exceeding the age of 85."

Answered by AI

Is this research endeavor actively looking to enroll participants?

"Affirmative, this research effort is currently open for enrolment as indicated on clinicaltrials.gov; it was originally posted in June 2017 and most recently revised at the end of October 2022."

Answered by AI

How many individuals are being included in this research endeavor?

"Affirmative. Per the information hosted on clinicaltrials.gov, this medical research has been recruiting since June 12th 2017 and is currently looking to enroll 120 participants from one site. This study was most recently edited on October 31st 2022."

Answered by AI

Recent research and studies

Journal of Clinical NeuroscienceJournal

Ventriculostomy: Frequency, Length of Stay and In-hospital Mortality in the United States of America, 1988–2010

Rosenbaum, Benjamin P., Sumeet Vadera, Michael L. Kelly, Varun R. Kshettry, and Robert J. Weil. 2014. “Ventriculostomy: Frequency, Length of Stay and In-hospital Mortality in the United States of America, 1988–2010”. Journal of Clinical Neuroscience. Elsevier BV. doi:10.1016/j.jocn.2013.09.001.

Journal of Trauma: Injury, Infection & Critical CareJournal

The Relationship Between INR and Development of Hemorrhage with Placement of Ventriculostomy

Bauer, David F., Gerald McGwin, Sherry M. Melton, Richard L. George, and James M. Markert. 2011. “The Relationship Between INR and Development of Hemorrhage with Placement of Ventriculostomy”. Journal of Trauma: Injury, Infection & Critical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ta.0b013e3181e7c2ae.

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal

Gprobe

Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.

NeurosurgeryJournal