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Status unknownNCT05254353CSF3SUpdated Jul 1, 2024

Comparison of Different CSF Sampling Sites on External Ventricular Drains

An observational study in Cerebrospinal Fluid, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2024-07-01.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
55
Sex
All
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Study 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 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.

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Conditions studied

  • Cerebrospinal Fluid

Keywords

  • neurosurgery
  • CSF
  • EVD
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In context

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 959 studies on the registry; 263 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with an external ventricular drain (EVD) presenting to the Neurosurgery ward.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients in whom the removal of the drain is planned within 48 hours, before routine sampling, will be excluded.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
55 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with EVD

    Procedure: Analyses of proximal and distal samples

Interventions

  • ProcedureAnalyses of proximal and distal samples

    Evaluate the difference between proximal and distal CSF samples

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1-4 and day 5-9 after placement of EVD

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05254353
Responsible party
Sponsor
First posted
Feb 24, 2022
Start date
Jan 31, 2022
Primary completion
Jan 2025 (estimated)
Completion
Jan 2025 (estimated)
Last update
Jul 1, 2024

Study contacts

Philippe De Vloo, prof.dr.
Contact
neurochirurgie@uzleuven.be
016 344290
Tom Deleu, dr.
Contact
neurochirurgie@uzleuven.be
016 344290
Philippe De Vloo, prof.dr.
principal investigator · UZ Leuven

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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