OcclusionNCT03248739
Comparison of EVD Catheter Diameter on Occlusion and Replacement
A study testing Clear Bactiseal 'large' catheter (EVD) and Orange Bactiseal 'small' catheter (EVD) in people with Occlusion, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Occlusion
- What is being tested?
- Clear Bactiseal 'large' catheter (EVD) and Orange Bactiseal 'small' catheter (EVD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2017to 4 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27104
About this study
Official title: A Comparison of External Ventricular Drain Catheter Diameter on Occlusion and Replacement: A Randomized Trial
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.
Read the 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).
- Conditions
- Occlusion
- Being tested
- Clear Bactiseal 'large' catheter (EVD), Orange Bactiseal 'small' catheter (EVD)
- Keywords
- Catheter, Ventricular, External Ventricular Drain Catheter, EVD Catheter, Occlusion, Ventriculostomy, Clear Bactiseal catheter, Orange Bactiseal catheter, Ventriculostomy Occlusion, Neurosurgery
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear Bactiseal 'large' catheter (EVD)Device
Antibiotic-impregnated 'large' catheter (inner diameter 1.9 mm, outer diameter 3.4 mm)
Orange Bactiseal 'small' catheter (EVD)Device
Antibiotic-impregnated 'small' catheter (inner diameter 1.5 mm, outer diameter 3 mm)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Orange Bactiseal 'small' catheter (EVD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 weeks
Secondary outcomes (4)
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.
Measured: Up to 4 weeks
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.
Measured: Up to 4 weeks
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.
Measured: 48 hours after placement.
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).
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start12 Jun 2017
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Why it stopped: Preliminary data did not show a difference. PI decided to terminate study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for OcclusionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle M Fargen, MD, Principal investigator, Assistant Professor, Surgery Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248739
- Sponsor's protocol ID
- IRB00042079
- Status last verified
- Oct 2022
- First submitted
- 4 Aug 2017
- Last updated
- 25 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 24630243Abla 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.
PubMed 21135715Tse 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.
PubMed 20975968Bauer 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.
PubMed 20805772Fichtner 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.
PubMed 19764827Kakarla 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.
PubMed 18728595Khanna 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.
PubMed 7472544Bogdahn 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.
PubMed 1436414Olson 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.
PubMed 23957382Chi 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.
PubMed 19647466Gilard 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.
PubMed 27729301Rahman 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.
PubMed 23130392
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of External Ventricular Drain Catheter Diameter on Occlusion and Replacement: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03248739
- Acronym / sponsor ID
- IRB00042079
- Conditions
- Occlusion
- Keywords
- Catheter, Ventricular, External Ventricular Drain Catheter, EVD Catheter, Occlusion, Ventriculostomy, Clear Bactiseal catheter, Orange Bactiseal catheter
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary data did not show a difference. PI decided to terminate study.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Posted 25 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear Bactiseal 'large' catheter (EVD) | Active comparator | Device: 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. |
| Orange Bactiseal 'small' catheter (EVD) | Active comparator | Device: 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clear Bactiseal 'large' catheter (EVD)Antibiotic-impregnated 'large' catheter (inner diameter 1.9 mm, outer diameter 3.4 mm) | Device | Clear Bactiseal 'large' catheter (EVD) |
| Orange Bactiseal 'small' catheter (EVD)Antibiotic-impregnated 'small' catheter (inner diameter 1.5 mm, outer diameter 3 mm) | Device | Orange Bactiseal 'small' catheter (EVD) |
Primary outcome
Number of Participants With Permanent Catheter Occlusions
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.
4 secondary outcomes
Number of Participants With Catheter Replacements
Time frame: Up to 4 weeks
Number of Participants With Temporary Occlusions
Time frame: Up to 4 weeks
Number of Participants With Procedure-related Hemorrhages
Time frame: 48 hours after placement.
Number of Participants With Symptomatic Hemorrhages
Time frame: Up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24630243Rosenbaum 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.
- Background: PubMed 21135715Abla 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.
- Background: PubMed 20975968Tse 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.
- Background: PubMed 20805772Bauer 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.
- Background: PubMed 19764827Fichtner 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.
- Background: PubMed 18728595Kakarla 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.
- Background: PubMed 7472544Khanna 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.
- Background: PubMed 1436414Bogdahn 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.
- Background: PubMed 23957382Olson 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.
- Background: PubMed 19647466Chi 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.
- Background: PubMed 27729301Gilard 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.
- Background: PubMed 23130392Rahman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle M Fargen, MD principal investigator
Assistant Professor, Surgery Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear Bactiseal 'large' catheter (EVD) and Orange Bactiseal 'small' catheter (EVD) in people with Occlusion, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Permanent Catheter Occlusions (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248739, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023; AzTrials last refreshed its copy on 3 Nov 2026.