Cerebrospinal FluidCSF3SNCT05254353
Comparison of Different CSF Sampling Sites on External Ventricular Drains
An observational study of Cerebrospinal Fluid, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aim of the current study is to evaluate the difference between proximal and distal CSF sampling. If the characteristics of distally and proximally sampled CSF are similar or correlate well, it may be possible to only sample CSF distally in the future, thereby avoiding the risks mentioned above. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrospinal Fluid
- What is being tested?
- Analyses of proximal and distal samples
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jan 2022to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with an external ventricular drain (EVD) presenting to the Neurosurgery ward.
Who may be able to join
- Patients with an EVD in place regardless of the underlying pathology.
- Written informed consent to participate in the study must be obtained from the subject. If the subject is not capable of self-consent, all efforts will be made to locate a legally acceptable representative to act on behalf of the subject.
- When the patient is considered capable to consent but physically unable to sign an informed consent form and a representative is not available an impartial witness can attend the informed consent process.
- Males and females of all ages, including children and pregnant females
Who cannot join
- Patients in whom the removal of the drain is planned within 48 hours, before routine sampling, will be excluded.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Philippe De Vloo, prof.dr., 016 344290, neurochirurgie@uzleuven.be
About this study
The aim of the current study is to evaluate the difference between proximal and distal CSF sampling. If the characteristics of distally and proximally sampled CSF are similar or correlate well, it may be possible to only sample CSF distally in the future, thereby avoiding the risks mentioned above.
Read the detailed description
Insertion of an external ventricular drain (EVD) is a common neurosurgical procedure, for example in patients with intracranial bleeding, head trauma of tumours. The aim of an external ventricular drain is either to drain cerebrospinal fluid (CSF) or to measure intracranial pressure. In patients with external ventricular drains, it is a common practice in many centres, including UZ Leuven, to routinely sample CSF two or three times a week. The following tests are routinely performed: protein level, glucose level, lactate level, white cell count, red cell count, and cultures. Gram stain is performed in case white blood cell count exceeds 5 cells/mm³. This regular sampling (1) permits early detection of ventriculitis, which may be rather asymptomatic, especially in sedated patients,and (2) may guide neurosurgeons to the ideal timeframe to either taper the external ventricular drainage, or replace it by a ventriculoperitoneal shunt.
A typical external ventricular drainage system consists of a ventricular catheter, which is nowadays usually impregnated with antibiotics (e.g. Codman Bactiseal - coated with clindamycin and rifampicin), an extension tube, a drip chamber, and a collection bag. Multiple three-way taps and access ports along its course allow for CSF sampling (or injection of therapeutics, such as tissue plasminogen activator, or saline to flush the catheter in case of blockage).
From a practical perspective, CSF sampling from the external ventricular drain is possible at all of these three-way taps and access ports. Broadly, one may sample CSF as proximally (close to the ventricle) as possible (e.g. by using the access port), or distally (at the level of the drip chamber, e.g. by using the three-way tap between the drip chamber and the collection bag). There is no consistency in for CSF collection site amongst different institutions. Traditionally, in UZ Leuven, we have been sampling CSF proximally until now.
The main theoretical advantage of proximal sampling is that actively aspirated "fresh" CSF close to the ventricle likely closely resembles the true characteristics of our study object, i.e. intraventricular CSF. Nevertheless, this approach is not without risk. First, it requires to directly access the sterile inside of the extension tube. This inherently comes with a risk of iatrogenic infection. Secondly, by aspirating the external ventricular catheter, the neurosurgeon may induce an iatrogenic haemorrhage in the brain parenchyma or the ventricle, and/or direct trauma to the brain parenchyma, as in suboptimally positioned catheters or small ventricles, white matter or choroid plexus may be aspirated along with CSF. Because of the risk of iatrogenic infections, haemorrhage or trauma, it is our institutional policy that CSF sampling from external ventricular drains is performed by neurosurgeons only. This also poses practical problems and may delay sampling, especially in patients who are not admitted to neurosurgical wards (e.g. paediatric cases).
From a theoretical perspective, distal CSF sampling, at the level of the drip chamber, has multiple advantages. First, the risk of iatrogenic infections induced by CSF sampling is likely to be lower, as there is no direct contact between the CSF in the drip chamber and the intraventricular CSF. Secondly, there is no risk of inducing haemorrhages or brain trauma, as no "active" aspiration is required for CSF sampling. Hence, distal CSF sampling can perhaps also be carried out by physicians from other fields than neurosurgery, or by trained nurses. However, theoretically, it is possible that the characteristics of CSF sampled distally do not sufficiently resemble those of intraventricular CSF.
- Conditions
- Cerebrospinal Fluid
- Being tested
- Analyses of proximal and distal samples
- Keywords
- neurosurgery, CSF, EVD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analyses of proximal and distal samplesProcedure or surgery
Evaluate the difference between proximal and distal CSF samples
| Study group | Role | What they receive |
|---|---|---|
| Patients with EVD | Not described Receives: Procedure: Analyses of proximal and distal samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the CSF white cell count at day 1-4 and day 5-9 when comparing both sampling methods
The aim of the current study is to evaluate the difference between proximal and distal CSF sampling.
Measured: Day 1-4 and day 5-9 after placement of EVD
Secondary outcomes (9)
White cell count correlation for all the available time points
Measured: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Gram stain correlation for all the available time points
Measured: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Culture correlation for all the available time points
Measured: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Protein correlation for all the available time points
Measured: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Glucose correlation for all the available time points
Measured: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Lactate correlation for all the available time points
Measured: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Red cell count correlation for all the available time points
Measured: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Absolute difference between white blood cell count, protein, glucose, lactate, and red blood cell count
Measured: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
AEs likely related to CSF sampling, irrespective of the method (new or increased haemorrhage, infection)
Measured: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start31 Jan 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrospinal FluidStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe De Vloo, prof.dr., Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254353
- Sponsor's protocol ID
- S65845
- Acronym
- CSF3S
- Status last verified
- Jun 2024
- First submitted
- 19 Jan 2022
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different CSF Sampling Sites on External Ventricular Drains
- ClinicalTrials.gov ID
- NCT05254353
- Acronym / sponsor ID
- CSF3S / S65845
- Conditions
- Cerebrospinal Fluid
- Keywords
- neurosurgery, CSF, EVD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current study is to evaluate the difference between proximal and distal CSF sampling. If the characteristics of distally and proximally sampled CSF are similar or correlate well, it may be possible to only sample CSF distally in the future, thereby avoiding the risks mentioned above.
Detailed description
Insertion of an external ventricular drain (EVD) is a common neurosurgical procedure, for example in patients with intracranial bleeding, head trauma of tumours. The aim of an external ventricular drain is either to drain cerebrospinal fluid (CSF) or to measure intracranial pressure. In patients with external ventricular drains, it is a common practice in many centres, including UZ Leuven, to routinely sample CSF two or three times a week. The following tests are routinely performed: protein level, glucose level, lactate level, white cell count, red cell count, and cultures. Gram stain is performed in case white blood cell count exceeds 5 cells/mm³. This regular sampling (1) permits early detection of ventriculitis, which may be rather asymptomatic, especially in sedated patients,and (2) may guide neurosurgeons to the ideal timeframe to either taper the external ventricular drainage, or replace it by a ventriculoperitoneal shunt.
A typical external ventricular drainage system consists of a ventricular catheter, which is nowadays usually impregnated with antibiotics (e.g. Codman Bactiseal - coated with clindamycin and rifampicin), an extension tube, a drip chamber, and a collection bag. Multiple three-way taps and access ports along its course allow for CSF sampling (or injection of therapeutics, such as tissue plasminogen activator, or saline to flush the catheter in case of blockage).
From a practical perspective, CSF sampling from the external ventricular drain is possible at all of these three-way taps and access ports. Broadly, one may sample CSF as proximally (close to the ventricle) as possible (e.g. by using the access port), or distally (at the level of the drip chamber, e.g. by using the three-way tap between the drip chamber and the collection bag). There is no consistency in for CSF collection site amongst different institutions. Traditionally, in UZ Leuven, we have been sampling CSF proximally until now.
The main theoretical advantage of proximal sampling is that actively aspirated "fresh" CSF close to the ventricle likely closely resembles the true characteristics of our study object, i.e. intraventricular CSF. Nevertheless, this approach is not without risk. First, it requires to directly access the sterile inside of the extension tube. This inherently comes with a risk of iatrogenic infection. Secondly, by aspirating the external ventricular catheter, the neurosurgeon may induce an iatrogenic haemorrhage in the brain parenchyma or the ventricle, and/or direct trauma to the brain parenchyma, as in suboptimally positioned catheters or small ventricles, white matter or choroid plexus may be aspirated along with CSF. Because of the risk of iatrogenic infections, haemorrhage or trauma, it is our institutional policy that CSF sampling from external ventricular drains is performed by neurosurgeons only. This also poses practical problems and may delay sampling, especially in patients who are not admitted to neurosurgical wards (e.g. paediatric cases).
From a theoretical perspective, distal CSF sampling, at the level of the drip chamber, has multiple advantages. First, the risk of iatrogenic infections induced by CSF sampling is likely to be lower, as there is no direct contact between the CSF in the drip chamber and the intraventricular CSF. Secondly, there is no risk of inducing haemorrhages or brain trauma, as no "active" aspiration is required for CSF sampling. Hence, distal CSF sampling can perhaps also be carried out by physicians from other fields than neurosurgery, or by trained nurses. However, theoretically, it is possible that the characteristics of CSF sampled distally do not sufficiently resemble those of intraventricular CSF.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with EVD | – | Procedure: Analyses of proximal and distal samples |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with an external ventricular drain (EVD) presenting to the Neurosurgery ward.
Key inclusion criteria (4 listed)
- Patients with an EVD in place regardless of the underlying pathology.
- Written informed consent to participate in the study must be obtained from the subject. If the subject is not capable of self-consent, all efforts will be made to locate a legally acceptable representative to act on behalf of the subject.
- When the patient is considered capable to consent but physically unable to sign an informed consent form and a representative is not available an impartial witness can attend the informed consent process.
- Males and females of all ages, including children and pregnant females
Key exclusion criteria (1 listed)
- Patients in whom the removal of the drain is planned within 48 hours, before routine sampling, will be excluded.
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 |
|---|---|---|
| Analyses of proximal and distal samplesEvaluate the difference between proximal and distal CSF samples | Procedure or surgery | Patients with EVD |
Primary outcome
Change of the CSF white cell count at day 1-4 and day 5-9 when comparing both sampling methods
Time frame: Day 1-4 and day 5-9 after placement of EVD
The aim of the current study is to evaluate the difference between proximal and distal CSF sampling.
9 secondary outcomes
White cell count correlation for all the available time points
Time frame: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Gram stain correlation for all the available time points
Time frame: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Culture correlation for all the available time points
Time frame: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Protein correlation for all the available time points
Time frame: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Glucose correlation for all the available time points
Time frame: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Lactate correlation for all the available time points
Time frame: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Red cell count correlation for all the available time points
Time frame: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Absolute difference between white blood cell count, protein, glucose, lactate, and red blood cell count
Time frame: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
AEs likely related to CSF sampling, irrespective of the method (new or increased haemorrhage, infection)
Time frame: Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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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.
Philippe De Vloo, prof.dr. principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrospinal Fluid, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Jul 2024. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe De Vloo, prof.dr. (016 344290, neurochirurgie@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the CSF white cell count at day 1-4 and day 5-9 when comparing both sampling methods (time frame: Day 1-4 and day 5-9 after placement of EVD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2024.