Skip to content

Comparison of EVD Catheter Diameter on Occlusion and Replacement

A Comparison of External Ventricular Drain Catheter Diameter on Occlusion and Replacement: A Randomized Trial

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03248739
Enrollment
33
Registered
2017-08-14
Start date
2017-06-12
Completion date
2022-11-04
Last updated
2023-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occlusion

Keywords

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

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).

Interventions

DEVICEClear Bactiseal 'large' catheter (EVD)

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

DEVICEOrange Bactiseal 'small' catheter (EVD)

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

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Permanent Catheter OcclusionsUp to 4 weeksThis is defined by a non-functioning (non-patent) EVD where patency cannot be restored through catheter manipulation or flushing.

Secondary

MeasureTime frameDescription
Number of Participants With Catheter ReplacementsUp to 4 weeksDefined 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.
Number of Participants With Temporary OcclusionsUp to 4 weeksDefined 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.
Number of Participants With Procedure-related Hemorrhages48 hours after placement.Presence of new catheter-related intraparenchymal hemorrhage, subdural hematoma, or intraventricular hemorrhage on CT scan 48 hours after placement.
Number of Participants With Symptomatic HemorrhagesUp to 4 weeksPresence 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).

Countries

United States

Participant flow

Pre-assignment details

33 subjects were consented to study with 33 being randomized.

Participants by arm

ArmCount
Large
Large Bore Catheter (1.9mmID)
17
Small
Small Bore Catheter (1.5mm ID)
16
Total33

Baseline characteristics

CharacteristicLargeTotalSmall
Age, Continuous58.8 years
STANDARD_DEVIATION 13.9
60.5 years
STANDARD_DEVIATION 13.4
62.1 years
STANDARD_DEVIATION 13.1
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants33 Participants16 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
3 Participants6 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
13 Participants26 Participants13 Participants
Region of Enrollment
United States
17 participants33 participants16 participants
Sex: Female, Male
Female
10 Participants19 Participants9 Participants
Sex: Female, Male
Male
7 Participants14 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 170 / 16
other
Total, other adverse events
0 / 170 / 16
serious
Total, serious adverse events
0 / 170 / 16

Outcome results

Primary

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.

Time frame: Up to 4 weeks

Population: Randomized to Large or Small Bore Catheters

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
LargeNumber of Participants With Permanent Catheter Occlusions0 Participants
SmallNumber of Participants With Permanent Catheter Occlusions2 Participants
p-value: 0.23Fisher Exact
Secondary

Number of Participants With Catheter Replacements

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.

Time frame: Up to 4 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
LargeNumber of Participants With Catheter Replacements1 Participants
SmallNumber of Participants With Catheter Replacements3 Participants
Secondary

Number of Participants With Procedure-related Hemorrhages

Presence of new catheter-related intraparenchymal hemorrhage, subdural hematoma, or intraventricular hemorrhage on CT scan 48 hours after placement.

Time frame: 48 hours after placement.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
LargeNumber of Participants With Procedure-related Hemorrhages0 Participants
SmallNumber of Participants With Procedure-related Hemorrhages0 Participants
Secondary

Number of Participants With Symptomatic Hemorrhages

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).

Time frame: Up to 4 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
LargeNumber of Participants With Symptomatic Hemorrhages0 Participants
SmallNumber of Participants With Symptomatic Hemorrhages0 Participants
Secondary

Number of Participants With Temporary Occlusions

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.

Time frame: Up to 4 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
LargeNumber of Participants With Temporary Occlusions2 Participants
SmallNumber of Participants With Temporary Occlusions0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026