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Comparison of EVD Catheter Diameter on Occlusion and Replacement

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ClinicalTrials.gov Identifier: NCT03248739
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Occlusion Device: Clear Bactiseal 'large' catheter (EVD) Device: Orange Bactiseal 'small' catheter (EVD) Not Applicable

Detailed Description:

Ventriculostomy is a common neurosurgical procedure. A Nationwide Inpatient Sample (NIS) database study demonstrated a significant increase in ventriculostomy utilization from 1988-2010, with over 35,000 hospitalizations including a procedural code for ventriculostomy in 2010.

Ventriculostomy occlusion is a common complication after external ventricular drain (EVD) placement. A review of published prospective and retrospective studies indicates that approximately 1-7% of EVDs require replacement secondary to occlusion. Furthermore, in the NIS database study of over 101,000 hospitalizations in which ventriculostomy was performed, nearly 6% of patients required at least one additional ventriculostomy procedure. Studies have demonstrated non-patent EVD in 19-47% of patients, however these studies did not prospectively evaluate EVD occlusion as a primary endpoint, report on number of catheter irrigations performed, or identify risk factors for EVD occlusion.

Recently, the investigators completed a retrospective review of a prospectively collected database of patients undergoing bedside EVD placement with the primary outcome of interest being catheter occlusion. This sample included 101 patients over a 1 year period. Two Codman catheters were available for use (Clear Bactiseal 'large' catheter: outer diameter 3.4 mm, inner diameter 1.9 mm; and Orange Bactiseal 'small' catheter: outer diameter 3 mm, inner diameter 1.5 mm). The decision regarding which catheter to use was made at the time of the procedure based on resident preference and availability. Both temporary occlusion (requiring flushing but patency could be restored) and permanent catheter occlusion (requiring replacement) were common, occurring in 41% and 19% of patients, respectively. Over 25% of small catheters became occluded during the study period compared to 11% of large catheters. Small catheters were associated with a 3.4 times greater odds of occlusion than the larger diameter catheters on multivariable regression analysis. This study suggests that the preferential use of larger diameter catheters may reduce the risk of ventriculostomy occlusion and need for replacement, however the study was not randomized and catheter selection may have been biased.

Recently, a smaller retrospective study of patients with intraventricular hemorrhage performed by Gilard and colleagues demonstrated a lower rate of occlusion and no increased risk of hemorrhage with larger bore catheters. Otherwise, there is no data in the literature supporting the preferential use of catheters based on size (clinical equipoise).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Comparison of External Ventricular Drain Catheter Diameter on Occlusion and Replacement: A Randomized Trial
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Active Comparator: Clear Bactiseal 'large' catheter (EVD)
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)
Antibiotic-impregnated 'large' catheter (inner diameter 1.9 mm, outer diameter 3.4 mm)

Active Comparator: Orange Bactiseal 'small' catheter (EVD)
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)
Antibiotic-impregnated 'small' catheter (inner diameter 1.5 mm, outer diameter 3 mm)




Primary Outcome Measures :
  1. Permanent catheter occlusion [ Time Frame: Up to 4 weeks ]
    This is defined by a non-functioning (non-patent) EVD where patency cannot be restored through catheter manipulation or flushing.


Secondary Outcome Measures :
  1. Catheter replacement [ Time Frame: Up to 4 weeks ]
    Defined by replacement of the ipsilateral EVD due to permanent occlusion, or placement of a contralateral EVD in the setting of a non-functioning ipsilateral catheter. Catheters placed contralaterally in the setting of a functioning ipsilateral catheter will not be considered replacements.

  2. Temporary Occlusion [ Time Frame: Up to 4 weeks ]
    Defined by non-functioning (non-patent) catheter requiring neurosurgeon flushing or manipulation in order to restore patency. By definition, such maneuvers must restore patency of the EVD such that it is functioning normally afterwards. Multiple temporary occlusions may be possible.

  3. Procedure-related hemorrhage [ Time Frame: 48 hours after placement. ]
    Presence of new catheter-related intraparenchymal hemorrhage, subdural hematoma, or intraventricular hemorrhage on CT scan 48 hours after placement.

  4. Symptomatic hemorrhage [ Time Frame: Up to 4 weeks ]
    Presence of new neurologic deficits as a result of EVD-related hemorrhage, or resulting in need for further procedures due to new EVD-related hemorrhage (craniotomy for hematoma evacuation, ICP monitoring, etc).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248739


Contacts
Contact: Kyle M Fargen, MD 336-716-8641 kfargen@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27104
Contact: Kyle M Fargen, MD    336-716-8641    kfargen@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Kyle M Fargen, MD Assistant Professor, Surgery Neurosurgery

Publications:

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03248739     History of Changes
Other Study ID Numbers: IRB00042079
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Wake Forest University Health Sciences:
Catheter
Ventricular
External Ventricular Drain Catheter
EVD Catheter
Occlusion
Ventriculostomy
Clear Bactiseal catheter
Orange Bactiseal catheter
Ventriculostomy Occlusion
Neurosurgery

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents