Clinical trial NCT03248739: Comparison of EVD Catheter Diameter on Occlusion and Replacement
Official title: A Comparison of External Ventricular Drain Catheter Diameter on Occlusion and Replacement: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Occlusion
Keywords: Catheter
Ventricular
External Ventricular Drain Catheter
EVD Catheter
Occlusion
Ventriculostomy
Clear Bactiseal catheter
Orange Bactiseal catheter
Ventriculostomy Occlusion
Neurosurgery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Permanent Catheter Occlusions
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Number of Participants With Catheter Replacements
timeFrame: Up to 4 weeks
measure: Number of Participants With Temporary Occlusions
timeFrame: Up to 4 weeks
measure: Number of Participants With Procedure-related Hemorrhages
timeFrame: 48 hours after placement.
measure: Number of Participants With Symptomatic Hemorrhages
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Assistant Professor, Surgery Neurosurgery
name: Kyle M Fargen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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