Comparison of EVD Catheter Diameter on Occlusion and Replacement

NCT03248739 | Terminated Results FDA Device

• 1 other identifier: IRB00042079
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized trial comparing small versus large catheters in terms of occlusion and need for replacement to confirm differential occlusion risk based on catheter size. This study will be done to determine whether external ventricular drain catheter diameter has any effect on risk of occlusion.

Conditions

Occlusion

Keywords

Catheter; Ventricular; External Ventricular Drain Catheter; EVD Catheter; Occlusion; Ventriculostomy; Clear Bactiseal catheter; Orange Bactiseal catheter; Ventriculostomy Occlusion; Neurosurgery

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Permanent Catheter Occlusions

  This is defined by a non-functioning (non-patent) EVD where patency cannot be restored through catheter manipulation or flushing.

  Up to 4 weeks

Secondary Outcomes (4)

• Number of Participants With Catheter Replacements

  Up to 4 weeks

• Number of Participants With Temporary Occlusions

  Up to 4 weeks

• Number of Participants With Procedure-related Hemorrhages

  48 hours after placement.

• Number of Participants With Symptomatic Hemorrhages

  Up to 4 weeks

Study Arms (2)

Clear Bactiseal 'large' catheter (EVD)

ACTIVE COMPARATOR

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.

Device: Clear Bactiseal 'large' catheter (EVD)

Orange Bactiseal 'small' catheter (EVD)

ACTIVE COMPARATOR

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.

Device: Orange Bactiseal 'small' catheter (EVD)

Interventions

Clear Bactiseal 'large' catheter (EVD) DEVICE

Antibiotic-impregnated 'large' catheter (inner diameter 1.9 mm, outer diameter 3.4 mm)

Clear Bactiseal 'large' catheter (EVD)

Orange Bactiseal 'small' catheter (EVD) DEVICE

Antibiotic-impregnated 'small' catheter (inner diameter 1.5 mm, outer diameter 3 mm)

Orange Bactiseal 'small' catheter (EVD)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18-85 years old) with a Glasgow Coma Scale (GCS) score of 7 or higher requiring frontal EVD placement.
• Diagnoses: spontaneous subarachnoid hemorrhage, intraventricular hemorrhage, intraparenchymal or cerebellar hemorrhage due to aneurysm, arteriovenous malformation, arteriovenous fistula, hypertension, or idiopathic etiology.
• Also included are patients for whom the attending neurosurgeon decides that frontal EVD placement is indicated for patient treatment with planned cerebrospinal fluid (CSF) drainage for 72 hours or more.

You may not qualify if:

• GCS of 6 or less
• Hunt and Hess subarachnoid hemorrhage grade of 5.
• Age 86 or greater, or age 17 or less.
• Patient cannot consent and next of kin cannot consent prior to procedure.
• Diagnosis of traumatic brain injury, as the EVD is often clamped for extended periods of time.
• Patients anticoagulated prior to admission with warfarin, Effient, Plavix, therapeutic heparin infusion, therapeutic subcutaneous lovenox, therapeutic subcutaneous arixtra, or other therapeutic anticoagulant or antiplatelet agent (ASA not included).
• Plan for EVD placement through non-frontal burr hole.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27104, United States

Location

Related Publications (12)

• Rosenbaum BP, Vadera S, Kelly ML, Kshettry VR, Weil RJ. Ventriculostomy: Frequency, length of stay and in-hospital mortality in the United States of America, 1988-2010. J Clin Neurosci. 2014 Apr;21(4):623-32. doi: 10.1016/j.jocn.2013.09.001.

  PMID: 24630243 BACKGROUND

• Abla AA, Zabramski JM, Jahnke HK, Fusco D, Nakaji P. Comparison of two antibiotic-impregnated ventricular catheters: a prospective sequential series trial. Neurosurgery. 2011 Feb;68(2):437-42; discussion 442. doi: 10.1227/NEU.0b013e3182039a14.

  PMID: 21135715 BACKGROUND

• Tse Ts, Cheng K, Wong K, Pang K, Wong C. Ventriculostomy and Infection: A 4-year-review in a local hospital. Surg Neurol Int. 2010 Sep 9;1:47. doi: 10.4103/2152-7806.69033.

  PMID: 20975968 BACKGROUND

• Bauer DF, McGwin G Jr, Melton SM, George RL, Markert JM. The relationship between INR and development of hemorrhage with placement of ventriculostomy. J Trauma. 2011 May;70(5):1112-7. doi: 10.1097/TA.0b013e3181e7c2ae.

  PMID: 20805772 BACKGROUND

• Fichtner J, Guresir E, Seifert V, Raabe A. Efficacy of silver-bearing external ventricular drainage catheters: a retrospective analysis. J Neurosurg. 2010 Apr;112(4):840-6. doi: 10.3171/2009.8.JNS091297.

  PMID: 19764827 BACKGROUND

• Kakarla UK, Kim LJ, Chang SW, Theodore N, Spetzler RF. Safety and accuracy of bedside external ventricular drain placement. Neurosurgery. 2008 Jul;63(1 Suppl 1):ONS162-6; discussion ONS166-7. doi: 10.1227/01.neu.0000335031.23521.d0.

  PMID: 18728595 BACKGROUND

• Khanna RK, Rosenblum ML, Rock JP, Malik GM. Prolonged external ventricular drainage with percutaneous long-tunnel ventriculostomies. J Neurosurg. 1995 Nov;83(5):791-4. doi: 10.3171/jns.1995.83.5.0791.

  PMID: 7472544 BACKGROUND

• Bogdahn U, Lau W, Hassel W, Gunreben G, Mertens HG, Brawanski A. Continuous-pressure controlled, external ventricular drainage for treatment of acute hydrocephalus--evaluation of risk factors. Neurosurgery. 1992 Nov;31(5):898-903; discussion 903-4. doi: 10.1227/00006123-199211000-00011.

  PMID: 1436414 BACKGROUND

• Olson DM, Zomorodi M, Britz GW, Zomorodi AR, Amato A, Graffagnino C. Continuous cerebral spinal fluid drainage associated with complications in patients admitted with subarachnoid hemorrhage. J Neurosurg. 2013 Oct;119(4):974-80. doi: 10.3171/2013.6.JNS122403. Epub 2013 Aug 20.

  PMID: 23957382 BACKGROUND

• Chi H, Chang KY, Chang HC, Chiu NC, Huang FY. Infections associated with indwelling ventriculostomy catheters in a teaching hospital. Int J Infect Dis. 2010 Mar;14(3):e216-9. doi: 10.1016/j.ijid.2009.04.006. Epub 2009 Jul 31.

  PMID: 19647466 BACKGROUND

• Gilard V, Djoubairou BO, Lepetit A, Metayer T, Gakuba C, Gourio C, Derey S, Proust F, Emery E, Gaberel T. Small versus Large Catheters for Ventriculostomy in the Management of Intraventricular Hemorrhage. World Neurosurg. 2017 Jan;97:117-122. doi: 10.1016/j.wneu.2016.09.105. Epub 2016 Oct 10.

  PMID: 27729301 BACKGROUND

• Rahman M, Whiting JH, Fauerbach LL, Archibald L, Friedman WA. Reducing ventriculostomy-related infections to near zero: the eliminating ventriculostomy infection study. Jt Comm J Qual Patient Saf. 2012 Oct;38(10):459-64. doi: 10.1016/s1553-7250(12)38061-6.

  PMID: 23130392 BACKGROUND

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Results Point of Contact

• Title: Kyle Fargen
• Organization: Wake Forest University School of Medicine

kfargen@wakehealth.edu

336-716-8641

Study Officials

• Kyle M Fargen, MD

  Assistant Professor, Surgery Neurosurgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 14, 2017
• Study Start: June 12, 2017
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: October 25, 2023
• Results First Posted: October 25, 2023

Record last verified: 2022-10

Locations

US (1)